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Claforan

Claforan(cefotaxime sodium) – Sanofi-Aventis

THERAPEUTIC CLASS

Cephalosporin (3rd generation)

INDICATIONS

Treatment of lower respiratory tract (eg, pneumonia), genitourinary (eg, urinary tract infections, uncomplicated gonorrhea), gynecologic (eg, pelvic inflammatory disease, endometritis, pelvic cellulitis), intra-abdominal (eg, peritonitis), skin and skin structure, bone and/or joint, and CNS (eg, meningitis and ventriculitis) infections, and bacteremia/septicemia caused by susceptible strains of microorganisms. Surgical prophylaxis during surgical procedures classified as contaminated or potentially contaminated.

ADULT DOSAGE

Adults: IM: Gonococcal Urethritis/Cervicitis (Males/Females): 0.5g single dose. Rectal Gonorrhea: 0.5g (females) or 1g (males) single dose. IM/IV: Uncomplicated Infections: 1g q12h. Moderate-Severe Infections: 1-2g q8h. Surgical Prophylaxis: 1g 30-90 min before surgery. IV: Septicemia: 2g q6-8h. Life-Threatening Infections: 2g q4h. Max: 12g/day. Cesarean Section: 1g IV as soon as umbilical cord is clamped, then 1g IV/IM at 6 and 12 hrs after 1st dose. CrCl <20mL/min: Give 1/2 of usual dose.

PEDIATRIC DOSAGE

Pediatrics: 1 month-12 yrs: ≥50kg: Use adult dose. <50kg: 50-180mg/kg/day IM/IV divided in 4-6 doses. Max: 12g/day. 1-4 weeks: 50mg/kg IV q8h. 0-1 week: 50mg/kg IV q12h. CrCl <20mL/min: Give 1/2 of usual dose.

HOW SUPPLIED

Inj: 500mg [vial], 1g, 2g [vial, ADD-Vantage]. Also available as a Pharmacy Bulk Package. Refer to individual package insert for more information

WARNINGS/PRECAUTIONS

Possible cross-sensitivity to penicillins (PCNs) and other cephalosporins. Caution with PCN sensitive patients; d/c if an allergic reaction occurs. Clostridium difficile-associated diarrhea (CDAD) reported. May result in bacterial resistance with prolonged use or use in the absence of a proven/suspected bacterial infection or a prophylactic indication; take appropriate measures if superinfection develops. Caution with history of GI disease, particularly colitis. Reduce dose with renal dysfunction. Granulocytopenia and agranulocytosis may occur especially with long-term use; monitor blood count if therapy lasts >10 days. May be locally irritating to tissue; perivascular extravasation may result in tissue damage and require surgical treatment. Monitor infusion site for tissue inflammation. Lab test interactions may occur. Caution in elderly.

ADVERSE REACTIONS

Inj-site reactions (eg, pain, induration, tenderness, inflammation), hypersensitivity reactions.

DRUG INTERACTIONS

Increased nephrotoxicity with aminoglycosides; monitor renal function carefully, especially with high doses or prolonged therapy. Concomitant administration with probenecid may delay excretion and increase cefotaxime plasma concentrations. May potentiate renal toxicity of nephrotoxic drugs.

PREGNANCY

Category B, caution in nursing.

MECHANISM OF ACTION

3rd-generation cephalosporin; bactericidal activity results from inhibiting cell wall synthesis.

PHARMACOKINETICS

Absorption: IM: Tmax=30 min; Cmax=11.7mcg/mL (500mg), 20.5mcg/mL (1g). IV: Cmax=38.9mcg/mL (500mg), 101.7mcg/mL (1g), 214.4mcg/mL (2g). Distribution: Found in breast milk. Metabolism: Desacetyl derivative (major metabolite, active). Elimination: Urine (60%); T1/2=(IM, IV) 1 hr; (IV, Infants) >1500g; 3.4 hrs, ≤1500g; 4.6 hrs.

ASSESSMENT

Assess for previous hypersensitivity reactions to cephalosphorins, PCNs, or other drugs, history of GI disease, renal dysfunction, pregnancy/nursing status, and possible drug interactions. Obtain CBC with differential, platelet count, and specimens for bacteriologic culture.

MONITORING

Monitor for hypersensitivity reactions, arrhythmias, CDAD, superinfection, granulocytopenia, and agranulocytosis. Periodically monitor renal function, SrCr, and CBC.

PATIENT COUNSELING

Counsel that it only treats bacterial infections and it does not treat viral infections. Take exactly as directed; skipping doses or not completing full course of therapy may decrease effectiveness and increase resistance. Notify physician as soon as possible if watery/bloody diarrhea (with/without stomach cramps and fever) develops; inform that diarrhea may occur up to ≥2 months after treatment.

ADMINISTRATION/STORAGE

Administration: IM/IV route. Refer to PI for preparation and administration instructions. Storage: Premixed: ≤-20°C (-4°F). Powder: <30°C. Protect from elevated temperature and excessive light. Refer to PI for compatibility and stability of reconstituted drug.


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    Claforan

    Claforan

    Generic Name: cefotaxime sodium

    Dosage Form: injection

    For ProfessionalsSide EffectsInteractionsMore…

    Claforan Sterile Injection, USP 1 gm Vial

    Claforan Description

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Claforan (cefotaxime sodium) and other antibacterial drugs, Claforan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

    Sterile Claforan (cefotaxime sodium) is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2- carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Claforan contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of Claforan range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4.

    Claforan is supplied as a dry powder in conventional and ADD-Vantage® System compatible vials, infusion bottles, pharmacy bulk package bottles, and as a frozen, premixed, iso-osmotic injection in a buffered diluent solution in plastic containers. Claforan, equivalent to 1 gram and 2 grams cefotaxime, is supplied as frozen, premixed, iso-osmotic injections in plastic containers. Solutions range from very pale yellow to light amber. Dextrose Hydrous, USP has been added to adjust osmolality (approximately 1.7 g and 700 mg to the 1 g and 2 g cefotaxime dosages, respectively). The injections are buffered with sodium citrate hydrous, USP. The pH is adjusted with hydrochloric acid and may be adjusted with sodium hydroxide. The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

    Claforan – Clinical Pharmacology

    Following IM administration of a single 500 mg or 1 g dose of Claforan to normal volunteers, mean peak serum concentrations of 11.7 and 20.5 mcg/mL respectively were attained within 30 minutes and declined with an elimination half-life of approximately 1 hour. There was a dose-dependent increase in serum levels after the IV administration of 500 mg, 1 g, and 2 g of Claforan (38.9, 101.7, and 214.4 mcg/mL respectively) without alteration in the elimination half-life. There is no evidence of accumulation following repetitive IV infusion of 1 g doses every 6 hours for 14 days as there are no alterations of serum or renal clearance. About 60% of the administered dose was recovered from urine during the first 6 hours following the start of the infusion.

    Approximately 20–36% of an intravenously administered dose of 14C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15–25% as the desacetyl derivative, the major metabolite. The desacetyl metabolite has been shown to contribute to the bactericidal activity. Two other urinary metabolites (M2 and M3) account for about 20–25%. They lack bactericidal activity. A single 50 mg/kg dose of Claforan was administered as an intravenous infusion over a 10- to 15-minute period to 29 newborn infants grouped according to birth weight and age. The mean half-life of cefotaxime in infants with lower birth weights (£1500 grams), regardless of age, was longer (4.6 hours) than the mean half-life (3.4 hours) in infants whose birth weight was greater than 1500 grams. Mean serum clearance was also smaller in the lower birth weight infants. Although the differences in mean half-life values are statistically significant for weight, they are not clinically important. Therefore, dosage should be based solely on age. (See DOSAGE AND ADMINISTRATION section.) Additionally, no disulfiram-like reactions were reported in a study conducted in 22 healthy volunteers administered Claforan and ethanol.

    Microbiology

    The bactericidal activity of cefotaxime sodium results from inhibition of cell wall synthesis. Cefotaxime sodium has in vitro activity against a wide range of gram-positive and gram-negative organisms. Cefotaxime sodium has a high degree of stability in the presence of b-lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Cefotaxime sodium has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

    Aerobes, Gram-positive

    Enterococcus spp.

    Staphylococcus aureus1, including b-lactamase-positive and negative strains

    Staphylococcus epidermidis

    Streptococcus pneumoniae

    Streptococcus pyogenes (Group A beta-hemolytic streptococci)

    Streptococcus spp

    .

    1Staphylococci which are resistant to methicillin/oxacillin must be considered resistant to cefotaxime sodium.

    Aerobes, Gram-negative

    Acinetobacter spp.

    Citrobacter spp.

    Enterobacter spp.

    Escherichia coli

    Haemophilus influenzae (including ampicillin-resistant strains)

    Haemophilus parainfluenzae

    Klebsiella spp. (including Klebsiella pneumoniae)

    Morganella morganii

    Neisseria gonorrhoeae (including b-lactamase-positive and negative strains)

    Neisseria meningitidis

    Proteus mirabilis

    Proteus vulgaris

    Providencia rettgeri

    Providencia stuartii

    Serratia marcescens

    NOTE: Many strains of the above organisms that are multiply resistant to other antibiotics, e.g. penicillins, cephalosporins, and aminoglycosides, are susceptible to cefotaxime sodium. Cefotaxime sodium is active against some strains of Pseudomonas aeruginosa.

    Anaerobes

    Bacteroides spp., including some strains of Bacteroides fragilis

    Clostridium spp. (Note: Most strains of Clostridium difficile are resistant.)

    Fusobacterium spp. (Including Fusobacterium nucleatum).

    Peptococcus spp.

    Peptostreptococcus spp.

    Cefotaxime sodium also demonstrates in vitro activity against the following microorganisms but the clinical significance is unknown. Cefotaxime sodium exhibits in vitro minimal inhibitory concentrations (MICs) of 8 mcg/mL or less against most (greater than or  equal to 90%) strains of the following microorganisms; however, the safety and effectiveness of cefotaxime sodium in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials:

    Aerobes, Gram-negative

    Providencia spp.

    Salmonella spp. (including Salmonella typhi)

    Shigella spp.

    Cefotaxime sodium is highly stable in vitro to four of the five major classes of 5-lactamases described by Richmond et al.1, including type IIIa (TEM) which is produced by many gram-negative bacteria. The drug is also stable to b-lactamase (penicillinase) produced by staphylococci. In addition, cefotaxime sodium shows high affinity for penicillin-binding proteins in the cell wall, including PBP: Ib and III.

    Cefotaxime sodium and aminoglycosides have been shown to be synergistic in vitro against some strains of Pseudomonas aeruginosa but the clinical significance is unknown.

    Susceptibility Tests

    Dilution techniques

    Quantitative methods that are used to determine minimum inhibitory concentrations (MICs) provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized dilution method1 (broth or agar) or equivalent with cefotaxime sodium powder. The MIC values obtained should be interpreted according to the following criteria:

    When testing organisms* other than Haemophilus spp., Neisseria gonorrhoeae, and Streptococcus spp.

    MIC (mcg/mL

    Interpretation

    less than or equal to 8

    Susceptible (S)

    16-32

    Intermediate (I)

    greater than or equal to 64

    Resistant (R)

    When testing Haemophilus spp.b

    MIC (mcg/mL)

    Interpretation c

    less than or equal to 2

    Susceptible (S)

    When testing Streptococcus d

    MIC (mcg/mL)

    Interpretation

    less than or equal to 0.5

    Suscepible (S)

    1

    Intermediate (I)

    greater than or equal to 2

    Resistant (R)

    When testing Neisseria gonorrhoeae e

    MIC (mcg/mL)

    Interpretation c

    less than or equal to 5

    Susceptible (S)

    *Staphylococci exhibiting resistance to methicillin/oxacillin, should be reported as also resistant to cefotaxime despite apparent in

    vitro susceptibility.

    †Interpretive criteria is applicable only to tests performed by broth microdilution method using Haemophilus Test Media.2

    ‡The absence of resistant strains precludes defining any interpretations other than susceptible.

    § Streptococcus pneumoniae must be tested using cation-adjusted Mueller-Hinton broth with 2–5% lysed horse blood.

    ¶Interpretive criteria applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth

    supplement.2

    A report of Susceptible indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of Intermediate indicates that the result should be considered equivocal and if the microorganism is not fully susceptible to alternative clinically feasible drugs the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable, other therapy should be selected.  Standardized susceptibility test procedures require the use of laboratory control microorganisms to  control the technical aspects of the laboratory procedure. Standard cefotaxime sodium powder should provide the following MIC values:

    Microorganism

    MIC (mcg/mL)

    Eschenichia coli ATCC 25922

    0.06-0.25

    Staphylococcus aureus ATCC 29213

    1-4

    Pseudomonas aeruginosa ATCC 27853

    4-16

    Haemophilus influenzae a ATCC 49247

    0.12-0.5

    Streptococcus pneumoniae b ATCC 49619

    0.06-0.25

    Neisseria gonorrhoeae c ATCC 49226

    0.015-0.06

    a.Ranges applicable only to tests performed by broth microdilution method using Haemophilus Test Media.2

    b.Ranges applicable only to tests performed by broth microdilution method using cation-adjusted Mueller-Hinton broth with 2–5% lysed horse blood.2

    c.Ranges applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement.2

    Diffusion Techniques

    Quantitative methods that require measurements of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg cefotaxime sodium to test the susceptibility of microorganisms to cefotaxime sodium. Reports from the laboratory providing results of the standard single-disk susceptibility test using a 30 mcg cefotaxime sodium disk should be interpreted according to the following criteria:

    When testing organisms a other than Haemophilus spp., Neisseria gonorrhoeae, and Streptococcus spp.

    MIC (mcg/mL)

    Interpretation

    greater than or equal to 23

    Susceptible (S)

    15-22

    Intermediate (I)

    less than or equal to 14

    Resistant (R)

    When testing Haemophilus spp b

    Zone Diameter (mm)

    Interpretation c

    greater than or equal to 26

    Susceptible (S)

    When testing Streptococcus other than Streptococcus pneumoniae

    Zone Diameter (mm)

    Interpretation

    greater than or equal to 28

    Susceptible (S)

    26-27

    Intermediate (I)

    less than or equal to 25

    Resistant (R)

    When testing Neisseria gonorrhoeae d

    Zone Diameter (mm)

    Interpretation c

    greater than or equal to 30

    Susceptible (S)

    a. Staphylococci exhibiting resistance to methicillin/oxacillin, should be reported as also resistant to cefotaxime despite apparent in vitro susceptibility.

    b. Interpretive criteria is applicable only to tests performed by disk diffusion method using Haemophilus Test Media.3

    c. The absence of resistant strains precludes defining any interpretations other than susceptible.

    d. Interpretive criteria applicable only to tests performed by disk diffusion method using GC agar base with 1% defined growth supplement.3

    Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cefotaxime sodium.

    As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg cefotaxime sodium disk should provide the following zone diameters in these laboratory test quality control strains:

    Microorganism

    Zone Diameter (mm)

    Escherichia coli ATCC 25922

    29-35

    Staphylococcus aureus ATCC 25923

    25-31

    Pseudomonas aeruginosa ATCC 27853

    18-22

    Haemophilus influenzae a ATCC 49247

    31-39

    Neisseria gonorrhoeae b ATCC 49226

    38-48

    a. Ranges applicable only to tests performed by disk diffusion method using Haemophilus Test Media.3

    b. Ranges applicable only to tests performed by disk diffusion method using GC agar base with 1% defined growth supplement.3

    Anaerobic Techniques

    For anaerobic bacteria, the susceptibility to cefotaxime sodium as MICs can be determined by standardized test methods.4 The MIC values obtained should be interpreted according to the following criteria:

    MIC (mcg/mL)

    Interpretation

    less than or equal to 16

    susceptible (S)

    32

    Intermediate (I)

    greater than or equal to 64

    Resistant (R)

    Interpretation is identical to that stated above for results using dilution techniques.

    As with other susceptibility techniques, the use of laboratory control microorganisms is required to control the technical aspects of the laboratory standardized procedures. Standardized cefotaxime sodium powder should provide the following MIC values:

    Microorganism

    MIC (mcg/mL)

    Bacteroides fragilis a ATCC 25285

    8-32

    Bacteroides thetaiotaomicron ATCC 29741

    16-64

    Eubacterium lantem ATCC 43055

    64-256

    a. Ranges applicable only to tests performed by agar dilution method.

    INDICATIONS & USAGE

    Treatment

    Claforan is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

    (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes2 (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens2, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa).

    (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus2, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris2, Providencia stuartii, Morganella morganii2, Providencia rettgeri2, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains.

    (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species2, Klebsiella species2, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis2), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum2). Claforan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

    (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia).

    (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species2, Escherichia coli,Citrobacter species (including C. freundii2), Enterobacter species, Klebsiella species,

    Proteus mirabilis,Proteus vulgaris2, Morganella morganii, Providencia rettgeri2, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus2 species and Peptococcus species).

    (6) Intra-abdominal infections including peritonitis caused by Streptococcus species2, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus2 species and Peptococcus2 species) Proteus mirabilis2, and Clostridium species2.

    (7) Bone and/or joint infectionscaused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes2), Pseudomonas species (including P. aeruginosa2), and Proteus mirabilis2.

    (8) Central nervous system infections,e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, Claforan has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to Claforan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, Claforan may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient’s condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if Claforan is used concomitantly with an aminoglycoside.

    Prevention

    The administration of Claforan preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (e.g., abdominal or vaginal hysterectomy, gastrointestinal and genitourinary tract surgery) that may be classified as contaminated or potentially contaminated. In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of Claforan may also reduce the incidence of certain postoperative infections. See DOSAGE AND ADMINISTRATION section. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, Claforan should be given 1/2 or 1 1/2 hours before surgery. See DOSAGE AND ADMINISTRATION section. For patients undergoing gastrointestinal surgery, preoperative bowel preparation by mechanical cleansing as well as with a nonabsorbable antibiotic (e.g., neomycin) is recommended. If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapy may be instituted.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Claforan and other antibacterial drugs, Claforan should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

    Warnings

    Claforan is contraindicated in patients who have shown hypersensitivity to cefotaxime sodium, any component of Claforan, or the cephalosporin group of antibiotics.

    Warnings

    BEFORE THERAPY WITH Claforan IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOTAXIME SODIUM, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PATIENTS WITH TYPE I HYPERSENSITIVITY REACTIONS TO PENICILLIN. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO Claforan OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.

    During post-marketing surveillance, a potentially life-threatening arrhythmia was reported in each of six patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter. Therefore, cefotaxime should only be administered as instructed in the DOSAGE AND ADMINISTRATION section.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Claforan, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary

    since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

    Precautions

    General

    Prescribing Claforan in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Claforan should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Claforan is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime sodium in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime sodium be halved in patients with estimated creatinine clearances of less than 20 mL/min/1.73 m2. When only serum creatinine is available, the following formula5 (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

    Weight (kg) × (140 – age)

    Males:     72 × serum creatinine

    Females:     0.85 × above value

    As with other antibiotics, prolonged use of Claforan may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken. As with other beta-lactam antibiotics, granulocytopenia and, more rarely, agranulocytosis may develop during treatment with Claforan, particularly if given over long periods. For courses of treatment lasting longer than 10 days, blood counts should therefore be monitored. Claforan, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of Claforan responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of Claforan may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, infusion sites should be monitored regularly and changed when appropriate.

    Information for patients

    Patients should be counseled that antibacterial drugs including Claforan should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Claforan is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Claforan or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

    Drug Interactions

    Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics. Probenecid interferes with the renal tubular transfer of cephalosporins, thereby delaying their excretion and increasing their plasma concentrations. As with other cephalosporins, cefotaxime may potentiate the renal toxicity of nephrotoxic drugs. See INDICATIONS AND USAGE section.

    Drug/Laboratory Test Interactions

    Cephalosporins, including cefotaxime sodium, are known to occasionally induce a positive direct Coombs’ test. Urinary glucose testing with non-specific reducing agents may yield a false-positive reaction in patients treated with cefotaxime. This phenomenon is not seen when a glucose-oxidase specific method is used.

    Carcinogenesis, Mutagenesis

    Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Claforan was not mutagenic in the mouse micronucleus test or in the Ames test. Claforan did not impair fertility to rats when administered subcutaneously at doses up to 250 mg/kg/day (0.2 times the maximum recommended human dose based on mg/m2) or in mice when administered intravenously at doses up to 2000 mg/kg/day (0.7 times the recommended human dose based on mg/m2).

    Pregnancy

    Teratogenic Effects

    Pregnancy Category B: Reproduction studies have been performed in pregnant mice given Claforan intravenously at doses up to 1200 mg/kg/day (0.4 times the recommended human dose based on mg/m2) or in pregnant rats when administered intravenously at doses up to 1200 mg/kg/day (0.8 times the recommended human dose based on mg/m2). No evidence of embryotoxicity or teratogenicity was seen in these studies. Although cefotaxime has been reported to cross the placental barrier and appear in cord blood, the effect on the human fetus is not known. There are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Nonteratogenic Effects

    Use of the drug in women of child-bearing potential requires that the anticipated benefit be weighed against the possible risks. In perinatal and postnatal studies with rats, the pups in the group given 1200 mg/kg/day of Claforan were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of nursing.

    Nursing Mothers

    Claforan is excreted in human milk in low concentrations. Caution should be exercised when Claforan is administered to a nursing woman.

    Pediatric Use

    See Precautions above regarding perivascular extravasation. The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic in single dose Galaxy® containers (premixed Claforan Injection) has not been determined.

    Geriatric Use

    Of the 1409 subjects in clinical studies of cefotaxime, 632 (45%) were 65 and over, while 258 (18%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General).

    Adverse Reactions

    Clinical Trials Experience

    Claforan is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.

    The most frequent adverse reactions (greater than 1%) are:

    Local (4.3%) – Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection. Hypersensitivity (2.4%) – Rash, pruritus, fever, eosinophilia.

    Gastrointestinal (1.4%) – Colitis, diarrhea, nausea, and vomiting.

    Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely.

    Less frequent adverse reactions (less than 1%) are:

    Hematologic System – Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with Claforan and other cephalosporin antibiotics.  

    Genitourinary System – Moniliasis, vaginitis.

    Central Nervous System -    Headache.

    Liver – Transient elevations in AST, ALT,serum LDH,  and serum alkaline phosphatase levels have been reported.

    Kidney – As with some other cephalosporins, transient elevations of BUN and creatinine have been occasionally observed with Claforan.

    Cephalosporin Class Labeling

    In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. See DOSAGE AND ADMINISTRATION and OVERDOSAGE. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

    Overdosage

    The acute toxicity of Claforan was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral doses in excess of 6000 mg/kg/day in all groups. Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefotaxime sodium overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine. There is a risk of reversible encephalopathy in cases of administration of high doses of beta-lactam antibiotics including cefotaxime. No specific antidote exists. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

    DOSAGE & ADMINISTRATION

    Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Claforan may be administered IM or IV after reconstitution. Premixed Claforan Injection is intended for IV administration after thawing. The maximum daily dosage should not exceed 12 grams.

    GUIDELINES FOR DOSAGE OF Claforan

    Type of Infection

    Daily Dose (grams)

    Frequency and Route

    Gonococcal urethritis/cervicitis in males and females

    0.5

    0.5 gram IM (single dose)

    Rectal gonorrhea in females

    0.5

    0.5 gram IM (single dose)

    Rectal gonorrhea in males

    1

    1 gram IM (single dose)

    Uncomplicated infections

    2

    1 gram every 12 hours IM or IV

    Moderate to severe infections

    3-6

    1-2 grams every 8 hours IM or IV

    Infections commonly needing antibiotics in higher dosage (e.g., septicemia)

    6-8

    2 grams every 6-8 hours IV

    Life-threating infections

    up to 12

    2 grams every 4 hours IV

    If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism. To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

    Cesarean Section Patients

    The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

    Neonates, Infants, and Children

    The following dosage schedule is recommended:

    Neonates (birth to 1 month):

    0–1 week of age     50 mg/kg per dose every 12 hours IV

    1–4 weeks of age     50 mg/kg per dose every 8 hours IV

    It is not necessary to differentiate between premature and normal-gestational age infants.

    Infants and Children (1 month to 12 years):

    For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

    Geriatric Use

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

    Impaired Renal Function

    see PRECAUTIONS, General.

    NOTE: As with antibiotic therapy in general, administration of Claforan should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

    Preparation of Claforan Sterile

    Claforan for IM or IV administration should be reconstituted as follows:

    Approximate

    Diluent

    Withdrawable

    Concentration

    Strength

    (mL)

    Volume (mL)

    (mg/mL)

    500 mg vial*(IM)

    2

    2.2

    230

    1g vial* (IM)

    3

    3.4

    300

    2g vial* (IM)

    5

    6.0

    330

    500 mg vial* (IV)

    10

    10.2

    50

    1g vial* (IV)

    10

    10.4

    95

    2g vial*(IV)

    10

    11.0

    180

    1g infusion

    50-100

    50-100

    20-10

    2g infusion

    50-100

    50-100

    40-20

    (*) in conventional vials

    Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of Claforan range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

    For intramuscular use

    Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

    For intravenous use

    Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. Reconstitute INFUSION BOTTLES with 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection. For other diluents, see COMPATIBILITY AND STABILITY section.

    NOTE: Solutions of Claforan must not be admixed with aminoglycoside solutions. If Claforan and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

    A SOLUTION OF 1 G Claforan IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

    IM Administration

    As with all IM preparations, Claforan should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

    IV Administration

    The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

    For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the

    patient may be receiving other IV solutions. However, during infusion of the solution containing Claforan, it is advisable to discontinue temporarily the administration of other solutions at the same site.

    For the administration of higher doses by continuous IV infusion, a solution of Claforan may be added to IV bottles containing the solutions discussed below.

    Directions for use of Claforan Injection in Galaxy Container (PL 2040 Plastic)

    Claforan Injection in Galaxy containers (PL 2040 plastic) is for continuous or intermittent infusion using sterile equipment.

    Storage

    Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

    Thawing of Plastic Container

    Thaw frozen container at room temperature or under refrigeration (at or below 5°C). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

    Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

    DO NOT ADD SUPPLEMENTARY MEDICATION.

    The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

    The thawed solution is stable for 10 days under refrigeration (at or below 5°C) or 24 hours at or below 22°C. Do not refreeze thawed antibiotics.

    CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

    Preparation for Intravenous Administration

    1. Suspend container from eyelet support.

    2. Remove protector from outlet port at bottom of container.

    3. Attach administration set. Refer to complete directions accompanying set.

    Preparation of Claforan Sterile in ADD-Vantage System

    Claforan Sterile 1 g or 2 g may be reconstituted in 50 mL or 100 mL of 5% Dextrose or 0.9% Sodium Chloride in the ADDVantage diluent container. Refer to enclosed, separate INSTRUCTIONS FOR ADD-VANTAGE SYSTEM.

    Compatibility and Stability

    Solutions of Claforan Sterile reconstituted as described above (Preparation of Claforan Sterile) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

    Strength

    Reconstitured

    Stability at or

    Stability under

    Concentration

    below 22 degrees C

    Refrigeration

    mg/mL

    (at or below 5 degrees C)

    Original

    Plastic

    containers

    syringes

    500 mg vial IM

    230

    12 hours

    7 days

    5 days

    1g vial IM

    300

    12 hours

    7 days

    5 days

    2g vial IM

    330

    12 hours

    7 days

    5 days

    500 mg vial IV

    50

    24 hours

    7 days

    5 days

    1g vial IV

    95

    24 hours

    7 days

    5 days

    2g vial IV

    180

    12 hours

    7 days

    5 days

    1g infusion bottle

    10-20

    24 hours

    10 days

    2g infusion

    20-40

    24 hours

    10 days

    Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen. Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose

    Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer’s Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% TRAVASOL® (Amino Acid) Injection without Electrolytes. Solutions of Claforan Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in Viaflex® plastic containers maintain satisfactory potency for 24 hours at or below 22°C, 5 days under refrigeration (at or below 5°C) and 13 weeks frozen. Solutions of Claforan Sterile reconstituted in 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the ADDVantage flexible containers maintain satisfactory potency for 24 hours at or below 22°C. DO NOT FREEZE.

    NOTE: Claforan solutions exhibit maximum stability in the pH 5–7 range. Solutions of Claforan should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

    How is Claforan Supplied

    Sterile Claforan is a dry off-white to pale yellow crystalline powder supplied in vials and bottles containing cefotaxime sodium as follows:

    500 mg cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0017-10).

    1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0018-10), packages of 25 (NDC 0039-0018-25), packages of 50 (NDC 0039-0018-50); infusion bottles in packages of 10 (NDC 0039-0018-11).

    2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 0039-0019-10), packages of 25 (NDC 0039-0019-25), packages of 50 (NDC 0039-0019-50); infusion bottles in packages of 10 (NDC 0039-0019-11).

    1 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0023-25) and 50 (NDC 0039-0023-50).

    2 g cefotaxime (free acid equivalent) in ADD-Vantage System vials in packages of 25 (NDC 0039-0024-25) and 50 (NDC 0039-0024-50).

    ADD-Vantage System diluents (5% Dextrose or 0.9% Sodium Chloride) are available from Abbott Laboratories.

    Also available:

    Pharmacy Bulk Package:

    10g cefotaxime (free acid equivalent) in bottles (NDC 0039-0020-01)

    NOTE: Claforan in the dry state should be stored below 30°C. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light. Premixed Claforan Injection is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL single dose Galaxy containers (PL 2040 plastic) as follows:

    1 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0037-05) 2G3518.

    2 g cefotaxime (free acid equivalent) in packages of 12 (NDC 0039-0038-05) 2G3519.

    NOTE: Store Premixed Claforan Injection at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF Claforan (cefotaxime injection) IN GALAXY CONTAINERS (PL 2040 PLASTIC)].

    Claforan Injection supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in Galaxy containers (PL 2040 plastic) is manufactured for sanofi-aventis U.S. LLC by Baxter Healthcare Corporation.

    REFERENCES

        1) Richmond, M. H. and Sykes R. B.: The b-Lactamases of Gram-Negative Bacteria and their Possible Physiological Role, Advances in Microbial Physiology 9:31–88, 1973.

        2) National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Third Edition. Approved Standard NCCLS     Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.

        3) National Committee for Clinical Laboratory Standards. Performance Standard for Antimicrobial Disk Susceptibility Tests – Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol.         13, No. 24, NCCLS, Villanova, PA, December, 1993.

        4) National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – Third Edition. Approved Standard NCCLS Document M11-A3,     NCCLS, Villanova, PA, December, 1993.

        5) Cockcroft, D.W. and Gault, M.H.: Prediction of Creatinine Clearance from Serum Creatinine, Nephron 16:31–41, 1976.

    RX only

    Revised July 2009

    Manufactured for:

    sanofi-aventis U.S. LLC

    Bridgewater, NJ 08807

    Claforan Injection in Galaxy Containers:

    Manufactured by:

    Baxter Healthcare Corporation

    Deerfield, IL 60015

    Manufactured for:

    sanofi-aventis U.S. LLC

    Bridgewater, NJ 08807

    2009 sanofi-aventis U.S. LLC

    50091941

    CNE 90003

    PACKAGE LABEL

    Claforan 

    cefotaxime sodium injection

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52584-018(NDC:0039-0018)
    Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cefotaxime Sodium (Cefotaxime) Cefotaxime 1 g  in 1 g
    Packaging
    # Item Code Package Description
    1 NDC:52584-018-01 1 VIAL (VIAL) in 1 BAG
    1 1 g in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA050547 06/07/2012
    Labeler - General Injectables & Vaccines, Inc (108250663)

    Revised: 06/2012   General Injectables & Vaccines, Inc

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    Claforan

    Claforan

    Generic Name: cefotaxime (SEF-oh-TAX-eem)

    Brand Name: Claforan

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Claforan is used for:

    Treating infections caused by certain bacteria. It is also used to prevent bacterial infections before, during, or after certain surgeries.

    Claforan is a cephalosporin antibiotic. It works by weakening and rupturing the cell wall, killing the bacteria.

    Do NOT use Claforan if:

    • you are allergic to any ingredient in Claforan or to any other cephalosporin antibiotic (eg, cephalexin)

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using Claforan:

    Some medical conditions may interact with Claforan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem)
    • if you have a history of stomach or bowel problems (eg, inflammation), blood clotting problems, or kidney or liver problems
    • if you have poor nutrition

    Some MEDICINES MAY INTERACT with Claforan. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Aminoglycosides (eg, gentamicin) because the risk of kidney side effects may be increased
    • Probenecid because it may increase the risk of Claforan’s side effects
    • Heparin because the risk of its side effects, including risk of bleeding, may be increased by Claforan

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Claforan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Claforan:

    Use Claforan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Claforan is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Claforan at home, a health care provider will teach you how to use it. Be sure you understand how to use Claforan. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
    • Do not use Claforan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
    • To clear up your infection completely, use Claforan for the full course of treatment. Keep using it even if you feel better in a few days.
    • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
    • If you miss a dose of Claforan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Claforan.

    Important safety information:

    • Claforan only works against bacteria; it does not treat viral infections (eg, the common cold).
    • Be sure to use Claforan for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
    • Long-term or repeated use of Claforan may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
    • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
    • Diabetes patients – Claforan may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
    • Claforan may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Claforan.
    • Lab tests, including kidney or liver tests or blood cell counts, may be performed while you use Claforan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • Use Claforan with caution in the ELDERLY; they may be more sensitive to its effects.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Claforan while you are pregnant. Claforan is found in breast milk. If you are or will be breast-feeding while you use Claforan, check with your doctor. Discuss any possible risks to your baby.

    Possible side effects of Claforan:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Headache; mild diarrhea; nausea; vomiting.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody diarrhea or stools; decreased urination; fever, chills, or persistent sore throat; irregular heartbeat; pain, swelling, or redness at the injection site; red, swollen, or blistered skin; seizures; severe diarrhea; severe nausea or vomiting; stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; white patches in mouth; yellowing of the eyes and skin.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures.

    Proper storage of Claforan: Claforan is usually handled and stored by a health care provider. If you are using Claforan at home, store Claforan as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Keep Claforan out of the reach of children and away from pets.

    General information:

    • If you have any questions about Claforan, please talk with your doctor, pharmacist, or other health care provider.
    • Claforan is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Claforan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Claforan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Claforan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Claforan.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Claforan

    Claforan

    Generic Name: cefotaxime (Injection route)

    sef-oh-TAX-eem

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Claforan

    Available Dosage Forms:

    • Powder for Solution

    Therapeutic Class: Antibiotic

    Pharmacologic Class: 3rd Generation Cephalosporin

    Uses For Claforan

    Cefotaxime injection is used to treat bacterial infections in many different parts of the body. This medicine is also given before, during, and after certain types of surgery to prevent infections.

    Cefotaxime injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

    This medicine is available only with your doctor’s prescription.

    Before Using Claforan

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefotaxime injection in children.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefotaxime injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefotaxime injection.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

    Breast Feeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Warfarin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Probenecid

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Blood or bone marrow problems (e.g., agranulocytosis, granulocytopenia) or
    • Colitis (inflammation in gut), history of or
    • Diarrhea, severe, history of—Use with caution. May make these conditions worse.
    • Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

    Proper Use of Claforan

    A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles or through a needle placed in one of your veins.

    Precautions While Using Claforan

    If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

    Cefotaxime injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

    Cefotaxime injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

    • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
    • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
    • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
    • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
    • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
    • Avoid contact sports or other situations where bruising or injury could occur.

    Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

    Claforan Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Less common

    • Abdominal or stomach cramps or tenderness
    • black, tarry stools
    • bloating
    • chest pain
    • chills
    • diarrhea
    • diarrhea, watery and severe, which may also be bloody
    • difficulty with breathing
    • difficulty with swallowing
    • dizziness
    • fast heartbeat
    • fever
    • hives
    • increased thirst
    • itching
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • nausea or vomiting
    • noisy breathing
    • pain
    • painful or difficult urination
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • shortness of breath
    • skin rash
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • swollen glands
    • tenderness
    • tightness in the chest
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • unusual weight loss
    • wheezing

    Rare

    • Agitation
    • back, leg, or stomach pains
    • bleeding gums
    • blistering, peeling, or loosening of the skin
    • blood in the urine or stools
    • bloody or cloudy urine
    • blurred vision
    • coma
    • confusion
    • cough or hoarseness
    • cracks in the skin at the corners of the mouth
    • dark urine
    • drowsiness
    • fainting
    • fast, slow, or irregular heartbeat
    • fever with or without chills
    • general body swelling
    • general feeling of tiredness or weakness
    • greatly decreased frequency of urination or amount of urine
    • hallucinations
    • headache
    • irritability
    • itching
    • itching of the vagina or genital area
    • joint or muscle pain
    • loss of appetite
    • lower back or side pain
    • mood or mental changes
    • nosebleeds
    • pain during sexual intercourse
    • pale skin
    • pinpoint red spots on the skin
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • seizures
    • soreness or redness around the fingernails and toenails
    • stiff neck
    • swelling of the feet or lower legs
    • thick, white vaginal discharge with no odor or with a mild odor
    • yellowing of the eyes or skin

    Incidence not known

    • Clay-colored stools
    • unpleasant breath odor
    • vomiting of blood

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Red streaks on the skin
    • swelling, tenderness, or pain at the injection site

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Claforan side effects (in more detail)

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    Claforan

    Claforan

    Generic Name: Cefotaxime Sodium
    Class: Third Generation Cephalosporins

    VA Class: AM117

    CAS Number: 64485-93-4

    For ProfessionalsSide EffectsInteractionsMore…

    Introduction

    Antibacterial; β-lactam antibiotic; third generation cephalosporin.a b

    Uses for Claforan

    Bone and Joint Infections

    Treatment of serious bone and joint infections caused by susceptible S. aureus, streptococci (including S. pyogenes), Pseudomonas (including Ps. aeruginosa), or P. mirabilis.230

    Genitourinary Tract Infections

    Treatment of serious genitourinary tract infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, enterococci, Citrobacter, Enterobacter, E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, Providencia stuartii, P. rettgeri, Pseudomonas (including Ps. aeruginosa), or S. marcescens.230

    Gynecologic Infections

    Treatment of gynecologic infections (including pelvic inflammatory disease [PID], endometritis, pelvic cellulitis) caused by susceptible S. epidermidis, streptococci (including enterococci), E. coli, Enterobacter, Klebsiella, P. mirabilis, Bacteroides (including B. fragilis), Clostridium, Fusobacterium (including F. nucleatum), Peptococcus, and Peptostreptococcus.230

    CDC states cefotaxime may be effective for PID, but is less active than cefoxitin against anaerobic bacteria.200 When an oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with oral doxycycline (with or without oral metronidazole).200 369 Because cefotaxime (like other cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.230 290

    Intra-abdominal Infections

    Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible streptococci, E. coli, Klebsiella, P. mirabilis, Clostridium, Bacteroides, or anaerobic cocci (including Peptococcus and Peptostreptococcus).230

    Meningitis and Other CNS Infections

    Treatment of meningitis and ventriculitis caused by susceptible H. influenzae, N. meningitidis, S. pneumoniae,230 275 291 294 296 335 E. coli, or K. pneumoniae.230 275 291 294 296 336

    A drug of choice when a third generation cephalosporin is indicated for empiric treatment of bacterial meningitis;275 290 296 319 should not be used alone for empiric treatment when Listeria monocytogenes, enterococci, staphylococci, or Ps. aeruginosa may be involved.275 290 296 319

    Treatment of brain abscesses and other CNS infections† (e.g., subdural empyema, intracranial epidural abscesses).319 336 347 Concomitant metronidazole usually recommended for empiric therapy;319 347 used in conjunction with a penicillinase-resistant penicillin or vancomycin if staphylococci suspected.319 347

    Respiratory Tract Infections

    Treatment of serious lower respiratory tract infections, including community-acquired pneumonia (CAP)211 269 342 caused by susceptible Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), other streptococci (except enterococci), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella, Haemophilus influenzae (including ampicillin-resistant strains), H. parainfluenzae, Proteus mirabilis, indole-positive Proteus, Serratia marcescens, Enterobacter, or Pseudomonas (including Ps. aeruginosa).230

    Recommended by ATS and IDSA as an alternative for treatment of CAP caused by penicillin-susceptible S. pneumoniae and as a preferred drug for treatment of CAP caused by penicillin-resistant S. pneumoniae, provided in vitro susceptibility has been demonstrated.269 Also recommended in certain combination regimens used for empiric treatment of CAP.269 Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).269

    For empiric inpatient treatment of CAP in patients not requiring treatment in an intensive care unit (non-ICU patients), IDSA and ATS recommend monotherapy with a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin).269

    For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) S. aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (moxifloxacin, gemifloxacin, levofloxacin).269

    Septicemia

    Treatment of bacteremia/septicemia caused by E. coli, Klebsiella, S. marcescens, S. aureus, or streptococci (including S. pneumoniae).230 An aminoglycoside often is used concomitantly.230

    Skin and Skin Structure Infections

    Treatment of serious skin and skin structure infections caused by susceptible S. aureus, S. epidermidis, S. pyogenes, other streptococci (including enterococci), Acinetobacter, E. coli, Citrobacter (including C. freundii), Enterobacter, Klebsiella, P. mirabilis, P. vulgaris, M. morganii, P. rettgeri, Pseudomonas, Serratia, Bacteroides (including B. fragilis), Fusobacterium (including F. nucleatum), or anaerobic cocci (including Peptococcus and Peptostreptococcus).230

    Capnocytophaga Infections

    Alternative to penicillin G for treatment of infections caused by Capnocytophaga† (e.g., septicemia, meningitis, endocarditis).211

    Gonorrhea and Associated Infections

    Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea caused by susceptible Neisseria gonorrhoeae in adults or adolescents.200 230 366 367 369 Drug of choice is IM ceftriaxone or oral cefixime.200 251 275 369 Although effective, CDC states that IM cefotaxime appears to offer no advantage over IM ceftriaxone.200

    Alternative for initial treatment of disseminated gonococcal infections† caused by susceptible N. gonorrhoeae.200 275 369 Ceftriaxone is usual drug of choice for initial parenteral treatment of disseminated gonorrhea in adults, adolescents, or children; CDC and AAP consider cefotaxime an alternative.200 275 369

    Treatment of disseminated gonococcal infections†,200 275 gonococcal scalp abscesses†,200 275 and gonococcal ophthalmia neonatorum† in neonates.200 275

    Lyme Disease

    Treatment of early neurologic Lyme disease† with acute neurologic manifestations such as meningitis or radiculopathy.273 275 351 354 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 Although an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) may be effective for early localized or early disseminated Lyme disease associated with erythema migrans in the absence of specific neurologic manifestations or advanced atrioventricular (AV) heart block,270 273 275 284 285 286 287 338 351 353 355 356 357 a parenteral regimen usually is recommended when there are acute neurologic manifestations.270 273 275 284 285 286 287 338 351 353 355 356

    Treatment of Lyme carditis† when a parenteral regimen is indicated.273 275 351 354 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 Although a parenteral regimen usually is recommended for initial treatment of hospitalized patients, an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) can be used to complete therapy and for the treatment of outpatients.273 275 351 354

    Treatment of Lyme arthritis† when a parenteral regimen is indicated.273 275 351 354 361 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.273 275 351 354 361 Although the comparative safety and efficacy of oral versus IV anti-infectives for treatment of Lyme arthritis have not been fully evaluated,351 those with concomitant neurologic disease generally should receive a parenteral regimen.273 275 351 354 361

    Treatment of late neurologic Lyme disease† affecting the CNS or peripheral nervous system (e.g., encephalopathy, neuropathy).351 IV ceftriaxone is the drug of choice; alternatives are IV cefotaxime or IV penicillin G.351

    Typhoid Fever and Other Salmonella Infections

    Treatment of typhoid fever (enteric fever) or septicemia caused by Salmonella typhi or S. paratyphi†, including multidrug-resistant strains.275 306

    Treatment of >;Salmonella gastroenteritis† caused by non-typhi Salmonella (e.g., S. enteritidis, S. typhimurium).211 245 275 309 Anti-infective treatment is indicated only in those with severe disease and in those at increased risk of invasive disease, including those <3–6 months of age or >50 years of age, those with hemoglobinopathies, severe atherosclerosis or valvular heart disease, prostheses, uremia, chronic GI disease, or severe colitis, and those immunocompromised because of malignancy, immunosuppressive therapy, HIV infection, or other immunosuppressive illness.211 245 275 309 Choice of anti-infective is based on in vitro susceptibility.211 245 275 309

    Vibrio Infections

    Treatment of severe Vibrio parahaemolyticus† infection when anti-infective therapy is indicated in addition to supportive care.218

    Treatment of infections caused by V. vulnificus†.211 250 Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.211 218 250 Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.250 294

    Yersinia Infections

    Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis†.218 245 275 Usually self-limited infections, but anti-infectives may be indicated in immunocompromised individuals, for severe infections, or when septicemia or other invasive disease occurs.218 245 275

    Perioperative Prophylaxis

    Perioperative prophylaxis to reduce the incidence of infection in patients undergoing contaminated or potentially contaminated surgery (e.g., GI and genitourinary surgery, abdominal or vaginal hysterectomy) and in patients undergoing cesarean section.230

    Other cephalosporins or cephamycins (cefazolin, cefotetan, cefoxitin) are the preferred drugs for perioperative prophylaxis.201 Cefotaxime and other third generation cephalosporins usually not used for perioperative prophylaxis since they are expensive, some are less active against staphylococci than cefazolin, they have a spectrum of activity wider than necessary for organisms encountered in elective surgery, and their use for prophylaxis promotes emergence of resistant organisms.201

    Claforan Dosage and Administration

    Administration

    Administer by IV injection or infusion or by deep IM injection.230

    IV route preferred in patients with septicemia, bacteremia, peritonitis, meningitis, or other severe or life-threatening infections or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly if shock is present.230

    Large IM doses may be painful; IV administration may be preferred when large doses are indicated.b

    Cefotaxime ADD-Vantage vials and the commercially available frozen cefotaxime injection in dextrose should be used only for IV infusion.

    For solution and drug compatibility information, see Compatibility under Stability.

    IV Injection

    Reconstitution

    Reconstitute vials containing 500 mg, 1 g, or 2 g of cefotaxime with 10 mL of sterile water for injection to provide solutions containing approximately 50, 95, or 180 mg/mL, respectively.230

    Rate of Administration

    Inject directly into a vein over a period of 3-5 minutes or slowly into the tubing of a freely flowing compatible IV solution.230

    Do not inject IV over <3 minutes; rapid (over <1 minute) injection is associated with potentially life-threatening arrhythmias.230

    IV Infusion

    Reconstitution and Dilution

    Reconstitute infusion bottles containing 1 or 2 g of cefotaxime with 50–100 mL of 0.9% sodium chloride injection or 5% dextrose injection to provide solutions containing 10–20 or 20–40 mg/mL, respectively.230 May be diluted further in 50 mL to 1 L of compatible IV solution.230

    Reconstitute 10-g pharmacy bulk package according to the manufacturer’s directions and then dilute further in a compatible IV solution.230

    Reconstitute ADD-Vantage vials or infusion bottles containing 1 or 2 g of cefotaxime according to the manufacturer’s directions.230

    Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.230 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.230 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.230 The injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.230

    Rate of Administration

    For intermittent IV infusion, infuse over 20–30 minutes via butterfly or scalp vein-type needles.b

    During infusion, discontinue other IV solutions flowing through a common administration tubing or site230 unless the solutions are known to be compatible and the flow-rate is adequately controlled.b

    IM Injection

    Inject IM deeply into a large muscle mass such as the upper outer quadrant of the gluteus maximus.230 Use aspiration to avoid inadvertent injection into a blood vessel.230

    2-g IM doses should be divided and administered at 2 different injection sites.230

    Reconstitution

    Reconstitute vials containing 500 mg, 1 g, or 2 g of cefotaxime with 2, 3, or 5 mL, respectively, of sterile or bacteriostatic water for injection to provide solutions containing approximately 230, 300, or 330 mg/mL, respectively.230

    Dosage

    Available as cefotaxime sodium; dosage expressed in terms of cefotaxime.230

    Pediatric Patients

    General Dosage in Neonates <1 Week of Age
    IV

    50 mg/kg every 12 hours for premature or full-term neonates <1 week of age recommended by manufacturers.230 366 367

    IV or IM

    AAP recommends 50 mg/kg every 12 hours for neonates <1 week of age weighing ≤2 kg and 50 mg/kg every 8 or 12 hours for those weighing >2 kg.275

    General Dosage in Neonates 1–4 Weeks of Age
    IV

    50 mg/kg every 8 hours recommended by manufacturers.230 366 367

    IV or IM

    AAP recommends 50 mg/kg every 12 hours for neonates 1–4 weeks of age weighing <1.2 kg; 50 mg/kg every 8 hours for those weighing 1.2–2 kg; and 50 mg/kg every 6 or 8 hours for those weighing >2 kg.275

    General Dosage in Children 1 Month to 12 Years of Age
    IV or IM

    50–180 mg/kg daily given in 4–6 equally divided doses in those weighing <50 kg.230 366 367 The higher dosage should be used for more severe or serious infections.230 366 367

    AAP recommends 75–100 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections and 150–200 mg/kg daily given in 3 or 4 equally divided doses for severe infections.275

    Children weighing >50 kg should receive the usual adult dosage.230 366 367 (See Adult Dosage under Dosage and Administration.)

    Meningitis and Other CNS Infections
    IV

    Manufacturers recommend that children 1 month to 12 years of age weighing <50 kg receive dosage at the high end of the range of 50–180 mg/kg daily.230 366 367 Some clinicians recommend that infants and children <18 years of age with meningitis receive 50 mg/kg IV every 6 hours.296 Others recommend 100–150 mg/kg daily given in divided doses every 8–12 hours in neonates ≤7 days of age, 150–200 mg/kg daily given in divided doses every 6–8 hours in neonates 8–28 days of age, and 225–300 mg/kg daily given in divided doses every 6–8 hours in older infants and children.365

    AAP recommends 300 mg/kg daily given in 3 or 4 divided doses for treatment of meningitis in pediatric patients beyond the neonatal period.275 If meningitis is known or suspected to be caused by S. pneumoniae, AAP recommends that infants and children ≥1 month of age or older receive 225–300 mg/kg daily given in divided doses every 6–8 hours.275 297

    Duration of treatment is 7 days for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis; ≥10–14 days for complicated cases or meningitis caused by S. pneumoniae; and ≥21 days for meningitis caused by susceptible Enterobacteriaceae.275 296 318

    Gonorrhea and Associated Infections
    Disseminated Gonococcal Infection or Gonococcal Scalp Abscess in Neonates†

    IV or IM 25 mg/kg every 12 hours for 7 days recommended by CDC and AAP; if meningitis is documented, continue for 10–14 days.200 275

    Disseminated Gonorrhea in Children ≥8 Years of Age or Weighing ≥45 kg†

    IV 1 g every 8 hours recommended by CDC and AAP.200 275 369 Continue for 7 days275 or discontinue 24–48 hours after improvement occurs and switch to an oral regimen (e.g., cefixime or cefpodoxime) to complete ≥7 days of treatment.200 275 369

    Lyme Disease†
    Early Neurologic Lyme Disease†

    IV 150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 10–28 days) recommended by IDSA and others for early Lyme disease in children with acute neurologic manifestations (e.g., meningitis, radiculopathy).273 351 354

    Lyme Carditis†

    IV 150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–21 days) recommended by IDSA and others for those with AV heart block and/or myopericarditis associated with early Lyme disease when a parenteral regimen is indicated (e.g., hospitalized patients).273 351 354

    Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.351

    Lyme Arthritis†

    IV 150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–28 days) for children with evidence of neurologic disease or when arthritis has not responded to an oral regimen.351

    Late Neurologic Lyme Disease†

    IV 150–200 mg/kg daily (up to 6 g daily) given in divided doses every 6–8 hours for 14 days (range: 14–28 days) recommended by IDSA for children with late neurologic disease affecting the CNS or peripheral nervous system.273 351

    Response to anti-infective treatment usually is slow and may be incomplete in such patients.351 IDSA states that retreatment is not recommended unless relapse is shown by reliable objective measures.351

    Adults

    General Adult Dosage
    Uncomplicated Infections

    IV or IM 1 g every 12 hours.230 366 367

    Moderate to Severe Infections

    IV or IM 1–2 g every 8 hours.230 366 367

    Severe or Life-threatening Infections

    IV 2 g every 6–8 hours.230 366 367 For life-threatening infections, 2 g every 4 hours.230 366 367

    Meningitis and Other CNS Infections
    IV

    2 g every 6–8 hours for 7–21 days.230 296 Some clinicians recommend 8–12 g daily in divided doses every 4–6 hours.365

    Duration of treatment is 7 days for uncomplicated meningitis caused by susceptible H. influenzae or N. meningitidis; ≥10–14 days for complicated cases or meningitis caused by S. pneumoniae; and ≥21 days for meningitis caused by susceptible Enterobacteriaceae.275 296 318

    Meningitis Caused by S. pneumoniae

    IV Initially, 350 mg/kg daily given in 4 divided doses; reduce dosage to 225 mg/kg daily given in 3 divided doses if organism is susceptible to penicillin.327 335

    Respiratory Tract Infections
    Community-acquired Pneumonia

    IV or IM 1 g every 6–8 hours.269

    Duration of treatment depends on the causative pathogen, illness severity at the onset of anti-infective therapy, response to treatment, comorbid illness, and complications.269

    Gonorrhea and Associated Infections
    Uncomplicated Urethral, Cervical, or Rectal Gonorrhea

    IM 500 mg as a single dose.200 230 366 367 369

    Manufacturers recommend 1 g as a single dose for treatment of rectal gonorrhea in males.230 366 367

    Disseminated Gonorrhea†

    IV CDC recommends 1 g every 8 hours; continue for 24–48 hours after improvement begins and switch to an oral regimen (cefixime or cefpodoxime) to complete ≥1 week of treatment.200 369

    Lyme Disease
    Early Neurologic Lyme Disease†

    IV 2 g every 8 hours for 14 days (range: 10–28 days) recommended by IDSA and others for adults with acute neurologic manifestations (e.g., meningitis, radiculopathy).273 351 354

    Lyme Carditis†

    IV 2 g every 8 hours for 14 days (range: 14–21 days) recommended by IDSA and others for adults with AV heart block and/or myopericarditis associated with early Lyme disease when a parenteral regimen is indicated (e.g., hospitalized patients).351 354

    Parenteral regimen can be switched to an oral regimen (doxycycline, amoxicillin, cefuroxime axetil) to complete therapy when clinically indicated.351

    Lyme Arthritis†

    IV 2 g every 8 hours for 14 days (range: 14–28 days) recommended by IDSA for adults with evidence of neurologic disease or when arthritis has not responded to an oral regimen.351

    Late Neurologic Lyme Disease†

    IV 2 g every 8 hours for 14 days (range: 14–28 days) recommended by IDSA for adults with late neurologic disease affecting the CNS or peripheral nervous system.273 351

    Response to anti-infective treatment usually is slow and may be incomplete in such patients.351 IDSA states that retreatment is not recommended unless relapse is shown by reliable objective measures.351

    Perioperative Prophylaxis
    Contaminated or Potentially Contaminated Surgery

    IV or IM 1 g 30–90 minutes prior to surgery.230

    Cesarean Section

    IV or IM 1 g IV as soon as the umbilical cord is clamped, followed by additional 1-g IM or IV doses given 6 and 12 hours after the first dose.230

    Prescribing Limits

    Pediatric Patients

    Maximum 12 g daily for children weighing >50 kg.230 366 367

    Adults

    Maximum 12 g daily.230 366 367

    Special Populations

    Hepatic Impairment

    No dosage adjustments required.289 290

    Renal Impairment

    Patients with Clcr <20 mL/minute per 1.73 m2 should receive 50% of the usual dose given at the usual time intervals.230

    Patients undergoing hemodialysis should receive 0.5–2 g as a single daily dose with a supplemental dose after each dialysis period.265

    Cautions for Claforan

    Contraindications

    • Known hypersensitivity to cefotaxime or other cephalosporins.230

    Warnings/Precautions

    Warnings

    Superinfection/Clostridium difficile-associated Diarrhea and Colitis

    Possible emergence and overgrowth of nonsusceptible organisms, especially Enterobacter, Pseudomonas, enterococci, or Candida.230 Careful observation of the patient is essential.230 Institute appropriate therapy if superinfection occurs.230

    Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.230 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefotaxime, and may range in severity from mild diarrhea to fatal colitis.230 Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.230

    Consider CDAD if diarrhea develops during or after therapy and manage accordingly.230 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.230

    If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.230 Some mild cases of CDAD may respond to discontinuance alone.230 342 343 344 345 346 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.230 342 343 344 345 346

    Cardiac Effects

    Potentially life-threatening arrhythmia reported with rapid injection (<1 minute) through a central venous catheter.230 Do not inject IV over <3 minutes.230 (See IV Injection under Dosage and Administration.)

    Sensitivity Reactions

    Hypersensitivity Reactions

    Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.230

    If a hypersensitivity reaction occurs, discontinue cefotaxime and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).230

    Cross-hypersensitivity

    Partial cross-allergenicity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.a

    Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.230 Cautious use recommended in individuals hypersensitive to penicillins:a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a

    General Precautions

    Selection and Use of Anti-infectives

    To reduce development of drug-resistant bacteria and maintain effectiveness of cefotaxime and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.230

    When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.230 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.230

    History of GI Disease

    Use with caution in patients with a history of GI disease, particularly colitis.230 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

    Local Effects

    May be locally irritating to tissues.230 Inflammation, phlebitis, and thrombophlebitis reported with IV administration;b pain, induration, and tenderness may occur at IM injection sites.230

    Perivascular extravasation responds to changing the infusion site;230 extensive perivascular extravasation may result in tissue damage requiring surgery.230

    Regularly monitor infusion sites and change site when appropriate.230

    Hematologic Effects

    Possible transient neutropenia, granulocytopenia, leukopenia, eosinophilia, or thrombocytopenia.230

    Agranulocytosis may occur rarely during prolonged therapy.230 Monitor blood cell counts if treatment lasts >10 days.230

    CNS Effects

    Seizures reported with some cephalosporins, especially in patients with renal impairment who received dosages inappropriate for the degree of renal impairment.230

    If seizures occur, discontinue cefotaxime and administer anticonvulsant therapy as indicated.230

    Sodium Content

    Contains approximately 50.5 mg (2.2 mEq) of sodium per g of cefotaxime.230 366 367

    Specific Populations

    Pregnancy

    Category B.230

    Lactation

    Distributed into milk; use with caution.230

    Pediatric Use

    Adverse effects similar to those reported in adults.291

    Safety of the chemical components that may leach out of the plastic containing commercially available frozen cefotaxime sodium injections not established.230

    Geriatric Use

    No overall differences in safety or efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.230 366 367

    Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.230 366 367 Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function.230 366 367 (See Renal Impairment under Dosage and Administration.)

    Hepatic Impairment

    Possible increased plasma half-life and clearance of cefotaxime and its major metabolite.117 289

    Renal Impairment

    Plasma half-life of cefotaxime and its major metabolite increased in severe renal impairment.13 16 19 Possibility of seizures if dosage is inappropriately high for the degree of renal impairment.230

    Dosage adjustment recommended in those with Clcr <20 mL/minute per 1.73 m3.230

    Common Adverse Effects

    Local reactions at injection sites, hypersensitivity reactions, GI effects.230

    Interactions for Claforan

    Specific Drugs and Laboratory Tests

    Drug or Test

    Interaction

    Comments

    Aminoglycosides

    Possible increased risk of nephrotoxicity.230

    In vitro evidence of additive or synergistic antibacterial activity; antagonism also reported.a

    Closely monitor renal function, especially if high aminoglycoside dosage is used or therapy is prolonged.230

    Administer separately; do not admix.230

    Probenecid

    Decreased renal clearance and increased concentrations of cefotaxime and its metabolites.b

    Tests for glucose

    Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution.a

    Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape.)a

    Claforan Pharmacokinetics

    Absorption

    Bioavailability

    Not appreciably absorbed from GI tract; must be administered parenterally.b

    Following IM administration, peak serum concentrations attained within 30 minutes.6 8 11 230

    Distribution

    Extent

    Widely distributed into body tissues and fluids, including aqueous humor, bronchial secretions,224 sputum, middle ear effusions, bone,115 bile,115 116 and ascitic,117 pleural, and prostatic fluids.9

    Distributed into CSF; highest concentrations attained in those with inflamed meninges.263 264 288 290 b

    Crosses the placenta21 and is distributed into milk.21

    Plasma Protein Binding

    13–38%.2 6 11

    Elimination

    Metabolism

    Partially metabolized in the liver to desacetylcefotaxime, which has antibacterial activity.2 7 14 Desacetylcefotaxime is further metabolized into inactive metabolites in the liver.2 7 14 18

    Elimination Route

    Cefotaxime and its metabolites excreted principally in urine.2 14 In adults with normal renal function, 40–60% of a dose excreted as unchanged drug; 24% excreted as the active metabolite.b

    Half-life

    Terminal serum half-life of cefotaxime and desacetylcefotaxime is 0.9–1.7 and 1.4–1.9 hours, respectively.2 7 10 11 13 14 19

    Special Populations

    Terminal half-lives of cefotaxime and desacetylcefotaxime may be prolonged in patients with hepatic impairment.117 289

    Terminal half-life of cefotaxime only slightly prolonged in adults with Clcr ≥20 mL/minute per 1.73 m2.13 16 In those with Clcr of ≤10 mL/minute per 1.73 m2, terminal half-lives of 1.4–11.5 and 8.2–56.8 hours reported for cefotaxime and desacetylcefotaxime, respectively.13 16 19

    Stability

    Storage

    Parenteral

    Powder for Injection

    15–30°C;230 366 367 protect from light.230 366 367

    Powder for injection and solutions may darken.230

    IV solutions reconstituted with 0.9% sodium chloride injection or 5% dextrose injection and further diluted in a compatible IV solution are stable for 24 hours at room temperature (≤22°C) or at least 5 days refrigerated at ≤5°C.230 When reconstituted as directed in 0.9% sodium chloride injection or 5% dextrose injection, solutions prepared from ADD-Vantage vials are stable for 24 hours at room temperature (≤22°C); these solutions should not be frozen.230

    IM solutions containing 230–330 mg/mL prepared using sterile or bacteriostatic water for injection are stable in their original containers for 24 hours at room temperature (≤22°C) or 10 days refrigerated at ≤5°C and stable for 5 days in plastic syringes refrigerated at ≤5°C.230

    Injection (Frozen)

    -20°C or lower.230 After thawing, store up to 24 hours at room temperature (≤22°C) or up to 7 days under refrigeration (≤5°C).230

    Do not refreeze after thawing.230

    Compatibility

    For information on systemic interactions resulting from concomitant use, see Interactions.

    Parenteral

    Cefotaxime sodium is most stable at a pH of 5–7 and should not be diluted with IV solutions that have a pH >7.5 (e.g., sodium bicarbonate).230

    Solution Compatibility
    Compatible

    Dextrose 5 or 10% in waterHID 230

    Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%230

    Invert sugar 10%230

    Ringer’s injection, lactated230

    Sodium chloride 0.9%HID

    Sodium lactate (1/6) M230

    Travasol 8.5% without electrolytes230

    Drug Compatibility
    Admixture CompatibilityHID
    Compatible

    Clindamycin phosphate

    Metronidazole

    Metronidazole HCl

    Verapamil HCl

    Variable

    Amikacin sulfate

    Gentamicin sulfate

    Y-site CompatibilityHID
    Compatible

    Acyclovir sodium

    Amifostine

    Aztreonam

    Bivalirudin

    Cyclophosphamide

    Dexmedetomidine HCl

    Diltiazem HCl

    Docetaxel

    Etoposide phosphate

    Famotidine

    Fenoldopam mesylate

    Fludarabine phosphate

    Granisetron HCl

    Hetastarch in lactated electrolyte injection (Hextend)

    Hydromorphone HCl

    Levofloxacin

    Lorazepam

    Magnesium sulfate

    Melphalan HCl

    Meperidine HCl

    Midazolam HCl

    Milrinone lactate

    Morphine sulfate

    Ondansetron HCl

    Pemetrexed disodium

    Perphenazine

    Propofol

    Remifentanil HCl

    Sargramostim

    Teniposide

    Thiotepa

    Tolazoline HCl

    Vinorelbine tartrate

    Incompatible

    Allopurinol sodium

    Azithromycin

    Filgrastim

    Fluconazole

    Gemcitabine HCl

    Hetastarch in sodium chloride 0.9%

    Pentamidine isethionate

    Variable

    Vancomycin HCl

    Actions and Spectrum

    • Based on spectrum of activity, classified as a third generation cephalosporin.a Usually less active in vitro against susceptible staphylococci than first generation cephalosporins; has an expanded spectrum of activity against gram-negative bacteria compared with first and second generation cephalosporins.a b

    • Usually bactericidal.a
    • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.230 a
    • Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.a
    • Gram-positive aerobes: active in vitro and in clinical infections against S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), S. agalactiae (group B streptococci), S. aureus (including β-lactamase-producing strains), and some enterococci (e.g., Enterococcus faecalis).230 a b Also active in vitro against some viridans streptococci.350 Oxacillin-resistant (methicillin-resistant) staphylococci and some enterococci are resistant.a b
    • Gram-negative aerobes: active in vitro and in clinical infections against Acinetobacter, Citrobacter, Enterobacter, E. coli, H. influenzae (including ampicillin-resistant strains), H. parainfluenzae, Klebsiella, M. morganii, N. gonorrhoeae, N. meningitidis, P. mirabilis, P. vulgaris, P. rettgeri, P. stuartii, and Serratia.230 a b Also active in vitro against Campylobacter,222 223 Capnocytophaga,312 314 315 Eikenella corrodens,220 221 249 Moraxella,232 236 240 244 Salmonella,a b Shigella,a b and Vibrio vulnificus.292 Active against some strains of Pseudomonas aeruginosa, but less active against susceptible Ps. aeruginosa than ceftazidime.b
    • Anaerobes and other organisms: active in vitro and in clinical infections against Bacteroides, Eubacterium, Fusobacterium, Peptococcus, Peptostreptococcus, Propionibacterium, Veillonella, and some strains of Clostridium.230 265 a b Also active against the spirochete Borrelia burgdorferi.265

    Advice to Patients

    • Advise patients that antibacterials (including cefotaxime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).230

    • Importance of completing full course of therapy, even if feeling better after a few days.230
    • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefotaxime or other antibacterials in the future.230
    • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.230 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.230
    • Importance of informing clinicians if an allergic reaction occurs.230
    • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs as well as any concomitant illnesses.230
    • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
    • Importance of informing patients of other important precautionary information. (See Cautions.)

    Preparations

    Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Cefotaxime Sodium
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Parenteral

    For injection

    500 mg (of cefotaxime)*

    Cefotaxime Sodium for Injection

    Claforan

    Sanofi-Aventis

    1 g (of cefotaxime)*

    Cefotaxime Sodium for Injection

    Claforan

    Sanofi-Aventis

    2 g (of cefotaxime)*

    Cefotaxime Sodium for Injection

    Claforan

    Sanofi-Aventis

    10 g (of cefotaxime) pharmacy bulk package*

    Cefotaxime Sodium for Injection

    Claforan

    Sanofi-Aventis

    20 g (of cefotaxime) pharmacy bulk package*

    Cefotaxime Sodium for Injection

    For injection, for IV infusion

    1 g (of cefotaxime)

    Claforan

    Sanofi-Aventis

    Claforan ADD-Vantage

    Sanofi-Aventis

    2 g (of cefotaxime)

    Claforan

    Sanofi-Aventis

    Claforan ADD-Vantage

    Sanofi-Aventis

    * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

    Cefotaxime Sodium in Dextrose
    Routes

    Dosage Forms

    Strengths

    Brand Names

    Manufacturer

    Parenteral

    Injection (frozen), for IV infusion

    20 mg (of cefotaxime) per mL (1 g) in 3.4% Dextrose*

    Cefotaxime Sodium in Iso-osmotic Dextrose Injection (Galaxy)

    40 mg (of cefotaxime) per mL (2 g) in 1.4% Dextrose*

    Cefotaxime Sodium in Iso-osmotic Dextrose Injection (Galaxy)

    Disclaimer

    This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

    The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

    AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions December 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

    † Use is not currently included in the labeling approved by the US Food and Drug Administration.

    References

    2. Hoechst-Roussel Pharmaceuticals Inc. Claforan (cefotaxime sodium) sterile IM–IV: clinical and laboratory experience—an update. Somerville, NJ; 1981 Oct.

    6. Esmieu F, Guibert J, Rosenkilde HC. Pharmacokinetics of cefotaxime in normal human volunteers. J Antimicrob Chemother. 1980; 6(Suppl A):83-92. [PubMed 6252184]

    7. Reeves DS, White LO, Holt HA. Human metabolism of cefotaxime. J Antimicrob Chemother. 1980; 6(Suppl A):93-101. [PubMed 6252185]

    8. Neu HC, Aswapokee P, Fu KP et al. Cefotaxime kinetics after intravenous and intramuscular injection of single and multiple doses. Clin Pharmacol Ther. 1980; 27:677-85. [IDIS 113130] [PubMed 6245831]

    9. Grabe M, Andersson KE, Forsgren A et al. Concentrations of cefotaxime in serum, urine and tissues of urological patients. Infection. 1981; 9:154-8.

    10. Luthy R, Munch R, Blaser J et al. Human pharmacology of cefotaxime (HR 756), a new cephalosporin. Antimicrob Agents Chemother. 1979; 16:127-33. [IDIS 106317] [PubMed 485125]

    11. Fu K, Aswapokee P, Ho I et al. Pharmacokinetics of cefotaxime. Antimicrob Agents Chemother. 1979; 16:592-7. [IDIS 109979] [PubMed 526000]

    12. Wise R, Baker S, Livingston R. Comparison of cefotaxime and moxalactam pharmacokinetics and tissue levels. Antimicrob Agents Chemother. 1980; 18:369-71. [IDIS 122916] [PubMed 6252833]

    13. Wise R, Wright N, Wills PJ. Pharmacology of cefotaxime and its desacetyl metabolite in renal and hepatic disease. Antimicrob Agents Chemother. 1981; 19:526-31. [IDIS 133921] [PubMed 6264849]

    14. Luthy R, Blaser J, Bonetti A et al. Comparative multiple-dose pharmacokinetics of cefotaxime, moxalactam, and ceftazidime. Antimicrob Agents Chemother. 1981; 20:567-75. [IDIS 141468] [PubMed 6275776]

    15. Kafetzis DA, Brater DC, Kanarios J et al. Clinical pharmacology of cefotaxime in pediatric patients. Antimicrob Agents Chemother. 1981; 20:487-90. [IDIS 139336] [PubMed 6282194]

    16. Wise R, Wright N. cefotaxime metabolism and renal function. Lancet. 1979; 1:1106-7.

    17. Clumeck N, Vanhoof R, Valaethem Y. Cefotaxime and nephrotoxicity. Lancet. 1979; 1:835.

    18. Chamberlain J, Coombes JD, Dell D et al. Metabolism of cefotaxime in animals and man. J Antimicrob Chemother. 1980; 6(Suppl A):69-78. [PubMed 6252182]

    19. Fillastre JP, Leroy A, Humvert G et al. Pharmacokinetics of cefotaxime in subjects with normal and impaired renal function. J Antimicrob Chemother. 1980; 6(Suppl A):103-11. [PubMed 6252138]

    20. Karimi A, Seeger K, Stolke D et al. Cefotaxime concentration of cerebrospinal fluid. J Antimicrob Chemother. 1980; 6(Suppl A):119-20. [PubMed 6252140]

    21. Kafetzis DA, Lazarides CV, Siafas CA et al. Transfer of cefotaxime in human milk and from mother to fetus. J Antimicrob Chemother. 1980; 6(Suppl A):135-41. [PubMed 6252147]

    39. Kobayashi Y, Morikawa Y, Huruta T et al. Clinical evaluation of cefotaxime in the treatment of purulent meningitis in children. Clin Ther. 1981; 4(Suppl A):89-110. [PubMed 6276000]

    48. Neu HC, Aswapokee N, Fu KP et al. Antibacterial activity of a new 1-oxa cephalosporin compared with that of other β-lactam compounds. Antimicrob Agents Chemother. 1979; 16:141-9. [IDIS 132053] [PubMed 314774]

    50. Hall WH, Opfer BJ, Gerding DN. Comparative activity of the oxa-β-lactam LY127935, cefotaxime, cefoperazone, cefamandole, and ticarcillin against multiply resistant gram-negative bacilli. Antimicrob Agents Chemother. 1980; 17:273-9. [IDIS 111702] [PubMed 6247970]

    59. File TM, Tan JS. Enterococcal sensitivity to third generation cephalosporins. Lancet. 1981; 2:477. [PubMed 6115237]

    61. Kurtz TO, Winston DJ, Hindler JA et al. Comparative in vitro activity of moxalactam, cefotaxime, cefoperazone, piperacillin, and aminoglycosides against gram-negative bacilli. Antimicrob Agents Chemother. 1980; 18:645-8. [IDIS 123768] [PubMed 6255864]

    64. Lang SDR, Edwards DJ, Durack DT. Comparison of cefoperazone, cefotaxime, and moxalactam (LY127935) against aerobic gram-negative bacilli. Antimicrob Agents Chemother. 1980; 17:488-93. [IDIS 116143] [PubMed 6252831]

    65. Barza M, Tally FP, Jacobus NV et al. In vitro activity of LY127935. Antimicrob Agents Chemother. 1979; 16:287-92. [IDIS 132166] [PubMed 507785]

    66. Pulliam L, Hadley WK, Mills J. In vitro comparison of third-generation cephalosporins, piperacillin, dibekacin, and other aminoglycosides against aerobic bacteria. Antimicrob Agents Chemother. 1981; 19:490-2. [IDIS 134666] [PubMed 6454384]

    68. Wise R, Andrews JM, Bedford KA. LY127935, a novel oxa-β-lactam: an in vitro comparison with other β-lactam antibiotics. Antimicrob Agents Chemother. 1979; 16:341-5. [IDIS 132167] [PubMed 507788]

    69. Masuyoshi S, Arai S, Miyamoto M et al. In vitro antimicrobial activity of cefotaxime, a new cephalosporin. Antimicrob Agents Chemother. 1980; 18:1-8. [IDIS 131867] [PubMed 6251749]

    70. Cherubin CE, Corrado ML, Sierra MF et al. Susceptibility of gram-positive cocci to various antibiotics, including cefotaxime, moxalactam, and N-formimidoyl thienamycin. Antimicrob Agents Chemother. 1981; 20:553-5. [IDIS 139345] [PubMed 6282200]

    72. Trager GM, White GW, Zimelis VM et al. In vitro comparison of three new cephalosporins: LY-127935, cefotaxime and cefoperazone. Chemotherapy. 1981; 27:34-8. [IDIS 130358] [PubMed 6260435]

    75. Appelbaum PC, Tamim J, Stavitz J et al. Sensitivity of Acinetobacter calcoaceticus strains to seven cephalosporins. Lancet. 1981; 2:472. [IDIS 136435] [PubMed 6115226]

    78. Verbist L. Comparison of in vitro activities of eight β-lactamase-stable cephalosporins against β-lactamase-producing gram-negative bacilli. Antimicrob Agents Chemother. 1981; 19:407-13. [IDIS 134657] [PubMed 6972728]

    80. Tutlane VA, McCloskey RV, Trent JA. In vitro comparison of N-formimidoyl thienamycin, piperacillin, cefotaxime, and cefoperazone. Antimicrob Agents Chemother. 1981; 20:140-3. [IDIS 135358] [PubMed 6269481]

    100. Papdatos CJ, Kafetzis DA, Kanarios J. Cefotaxime in the treatment of severe paediatric infections. J Antimicrob Chemother. 1980; 6(Suppl A):243-8. [PubMed 6252164]

    106. King A, Warren C, Shannon K et al. The in vitro antibacterial activity of cefotaxime compared with that of cefuroxime and cefoxitin. J Antimicrob Chemother. 1980; 6:479-94. [IDIS 132028] [PubMed 6253433]

    109. Neu HC, Aswapokee N, Fu KP. HR 756, a new cephalosporin active against gram-positive and gram-negative aerobic and anaerobic bacteria. Antimicrob Agents Chemother. 1979; 15:273-81. [IDIS 123925] [PubMed 426518]

    115. Kosmidis J, Stathakis CH, Mantopoulos K et al. Clinical pharmacology of cefotaxime including penetration into bile, sputum, bone and cerebrospinal fluid. J Antimicrob Chemother. 1980; 6(suppl A):147-51. [PubMed 6252149]

    116. Soussy CJ, Deforges LP, Le Van Thoi J et al. Cefotaxime concentration in the bile and wall of the gallbladder. J Antimicrob Chemother. 1980; 6(Suppl A):125-30. [PubMed 6252143]

    117. Moreau L, Durand H, Biclet P et al. Cefotaxime concentrations in ascites. J Antimicrob Chemother. 1980; 6(Suppl A):121-2. [PubMed 6252141]

    200. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-96.

    201. Anon. Antimicrobial prophylaxis for surgery. Med Lett Treat Guid. 2004; 2:27-32.

    202. Barry AL, Brown SD, Novick WJ. In vitro activities of cefotaxime, ceftriaxone, ceftazidime, cefpirome, and penicillin against Streptococcus pneumoniae isolates. Antimicrob Agents Chemother. 1995; 39:2193-6. [IDIS 356005] [PubMed 8619565]

    203. National Committee for Clinical Laboratory Standards. Performance standards for antimicrobial susceptibility testing; twelfth informational supplement. NCCLS document M100-S12. Wayne, PA: NCCLS; 2002 Jan.

    210. Bartlett JG. Treatment of antibiotic-associated pseudomembranous colitis. Rev Infect Dis. 1984; 6(Suppl 1):S235-41.

    211. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:13-26.

    215. Sanders CC, Sanders WE Jr. Microbial resistance to newer generation β-lactam antibiotics: clinical and laboratory implications. J Infect Dis. 1985; 151:399-406. [PubMed 2982957]

    216. Sanders CC. Novel resistance selected by the new expanded-spectrum cephalosporins: a concern. J Infect Dis. 1983; 147:585-9. [IDIS 168702] [PubMed 6601169]

    217. Curtis NAC, Eisenstadt RL, Rudd C et al. Inducible type I β-lactamases of gram-negative bacteria and resistance to β-lactam antibiotics. J Antimicrob Chemother. 1986; 17:51-61. [PubMed 3485092]

    218. Centers for Disease Control and Prevention. Diagnosis and management of foodborne illness. A primer for physicians. MMWR Recomm Rep. 2001; 50(RR-2):1-69.

    219. Jones RN, Barry AL. Antimicrobial activity of ceftriaxone, cefotaxime, desacetylcefotaxime, and cefotaxime-desacetylcefotaxime in the presence of human serum. Antimicrob Agents Chemother. 1987; 31:818-20. [PubMed 3606081]

    220. Goldstein EJ, Cherubin CE, Shulman M. Comparison of microtiter broth dilution and agar dilution methods for susceptibility testing of Eikenella corrodens. Antimicrob Agents Chemother. 1983; 23:42-5. [IDIS 164447] [PubMed 6338819]

    221. Goldstein EJ, Gombert ME, Agyare EO. Susceptibility of Eikenella corrodens to newer beta-lactam antibiotics. Antimicrob Agents Chemother. 1980; 18:832-3. [IDIS 127705] [PubMed 7004350]

    222. Ahonkhai VI, Cerubin CE, Sierra MF et al. In vitro susceptibility of Campylobacter fetus subsp jejuni to N-formimidoyl thienamycin, rosaramicin, cefoperazone, and other antimicrobial agents.. Antimicrob Agents Chemother. 1981; 20:850-1. [IDIS 142043] [PubMed 6459767]

    223. Van der Auwera P, Scorneaux B. In vitro susceptibility of Campylobacter jejuni to 27 antimicrobial agents and various combinations of β-lactams with clavulanic acid or sulbactam. Antimicrob Agents Chemother. 1985; 28:37-40. [IDIS 203395] [PubMed 2994557]

    224. Fick RB, Alexander MR, Prince RA et al. Penetration of cefotaxime into respiratory secretions. Antimicrob Agents Chemother. 1987; 31:815-7. [IDIS 229469] [PubMed 3606080]

    225. Nichols RL, Wikler MA, McDevitt JT et al. Coagulopathy associated with extended-spectrum cephalosporins in patients with serious infections. Antimicrob Agents Chemother. 1987; 31:281-5. [IDIS 226549] [PubMed 3471181]

    226. Saxon A, Beall GN, Rohr AS et al. Immediate hypersensitivity reactions to beta-lactam antibiotics. Ann Intern Med. 1987; 107:204-15. [IDIS 233229] [PubMed 3300459]

    227. Norrby SR. Adverse reactions and interactions with newer cephalosporins and cephamycin antibiotics. Medical Toxicol. 1986; 1:32-46.

    228. Barriere SL, Flaherty JF. Third generation cephalosporins: a critical evaluation. Clin Pharm. 1984; 3:351-73. [IDIS 187699] [PubMed 6432420]

    229. Balant L, Dayer P, Auckenthaler R. Clinical pharmacokinetics of the third generation cephalosporins. Clin Pharmacokinet. 1985; 10:101-43. [IDIS 198911] [PubMed 3888488]

    230. Sanofi-Aventis. Claforan (cefotaxime) injection and for injection prescribing information. Bridgewater, NJ; 2007 May.

    231. American Academy of Pediatrics. Report of the task force on diagnosis and management of meningitis. Pediatrics. 1986; 78(Suppl):959-82. [IDIS 307460] [PubMed 3763317]

    232. Alvarez S, Jones M, Holtsclaw-Berk S et al. In vitro susceptibilities and β-lactamase production of 53 isolates of Branhamella catarrhalis. Antimicrob Agents Chemother. 1985; 27:646-7. [IDIS 198592] [PubMed 3873905]

    233. Hammerschlag MR, Gleyzer A. In vitro activity of a group of broad-spectrum cephalosporins and other β-lactam antibiotics against Chlamydia trachomatis. Antimicrob Agents Chemother. 1983; 23:493-4. [IDIS 167353] [PubMed 6847175]

    234. Muytjens HL, Heessen FW. In vitro activities of thirteen β-lactam antibiotics against Chlamydia trachomatis. Antimicrob Agents Chemother. 1982; 22:520-1. [IDIS 157302] [PubMed 7137988]

    235. Cullmann W, Opferkuch W, Stieglitz M et al. A comparison of the antibacterial activities of N-formimidoyl thienamycin (MKO787) with those of other recently developed β-lactam derivatives. Antimicrob Agents Chemother. 1982; 22:302-7. [IDIS 156712] [PubMed 6821459]

    236. Mandell W, Neu HC. In vitro activity of CI-934, a new quinolone, compared with that of other quinolones and other antimicrobial agents. Antimicrob Agents Chemother. 1986; 29:852-7. [PubMed 3729343]

    237. Neu HC, Labthavikul P. In vitro antibacterial activity and β-lactamase stability of E-0702, a new cephalosporin. Antimicrob Agents Chemother. 1983; 24:313-20. [IDIS 175794] [PubMed 6605718]

    238. Schell RF, Francisco M, Bihl JA et al. The activity of ceftazidime compared with those of aztreonam, newer cephalosporins and Sch 29482 against nonfermentative gram-negative bacilli. Chemotherapy. 1985; 31:181-90. [IDIS 200330] [PubMed 3888543]

    239. Fass RJ. In vitro activity of ciprofloxacin (Bay o 9867). Antimicrob Agents Chemother. 1983; 24:568-74. [IDIS 177504] [PubMed 6228192]

    240. Jones RN, Barry AL, Thornsberry C et al. The anti-microbial activity, beta-lactamase stability, and disk diffusion susceptibility testing of carumonam (RO 17-2301, AMA-1080), a new monobactam. Am J Clin Pathol. 1986; 86:608-18. [IDIS 222719] [PubMed 3096130]

    241. Eliopoulos GM, Reiszner E, Moellering RC Jr. In vitro activity of Sch 34343 against enterococci and other gram-positive bacteria. Antimicrob Agents Chemother. 1985; 27:28-32. [PubMed 3845792]

    242. Eliopoulos GM, Moellering AE, Reiszner E et al. In vitro activities of the quinolone antimicrobial agents A-56619 and A-56620. Antimicrob Agents Chemother. 1985; 28:514-20. [IDIS 207607] [PubMed 3935046]

    243. Baxter Healthcare Corporation. Descriptive information on premixed frozen products. Baxter Healthcare Corporation: Deerfield, IL; 1992 Sep.

    244. Calder MA, Croughan MJ, McLeod DT et al. The incidence and antibiotic susceptibility of Branhamella catarrhalis in respiratory infections. Drugs. 1986; 31(Suppl 3):11-6. [IDIS 217398] [PubMed 3488189]

    245. Guerrant RL, Gilder TV, Steiner TS et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001; 32:331-50. [IDIS 466024] [PubMed 11170940]

    246. Goldstein EJC, Citron DM. Comparative in vitro inhibitory and killing activity of cefpirome, ceftazidime, and cefotaxime against Pseudomonas aeruginosa, Enterococci, Staphylococcus epidermidis, and methicillin-susceptible and -resistant and tolerant and nontolerant Staphylococcus aureus. Antimicrob Agents Chemother. 1985; 28:160-2. [IDIS 203416] [PubMed 3929677]

    247. Garzone P, Lyon J, Yu VL. Third-generation and investigational cephalosporins: II. Microbiologic review and clinical summaries. Drug Intell Clin Pharm. 1983; 17:615-22. [IDIS 174601] [PubMed 6311502]

    248. Jones RN, Thornsberry C. Cefotaxime: a review of in vitro antimicrobial properties and spectrum of activity. Rev Infect Dis. 1982; 4(Suppl):S300-15.

    249. Goldstein EJC, Cherubin CE, Corrado ML et al. Comparative susceptibility of Yersinia enterolitica, Eikenella corrodens, and penicillin-resistant and penicillin-susceptible Streptococcus pneumoniae to β-lactam and alternative antimicrobial agents. Rev Infect Dis. 1982; 4(Suppl):S406-10.

    250. Anon. Vibrio vulnificus infections associated with eating raw oysters—Los Angeles, 1996. MMWR Morb Mortal Wkly Rep. 1996; 45:621-4. [PubMed 8965788]

    251. Anon. Drugs for sexually transmitted infections. Med Lett Treat Guid. 2004; 2:67-74.

    252. Kumar A, Kelly KJ. In vitro activity of cefixime (CL284635) and other antimicrobial agents against Haemophilus isolates from pediatric patients. Chemotherapy. 1988; 34:30-5. [IDIS 239247] [PubMed 3258232]

    253. Nakashio S, Nakamura M. In vitro activity of cefotaxime against clinically significant pathogens. Drugs. 1988; 35:14-21. [IDIS 241650] [PubMed 3260852]

    254. Kawakami Y, Okimura Y, Horiuchi N et al. In vitro activity of cefotaxime, ceftizoxime, cefmenoxime, and latamoxef in comparison with other β-lactam antibiotics against recent clinical isolates of Haemophilus influenzae and Haemophilus parainfluenzae. Microbiol Immunol. 1982; 26:617-21. [PubMed 6290854]

    255. Chin NX, Neu HC. In vitro antibacterial activity and beta-lactamase stability of CL 118523, an aminothiazol iminomethoxy cephalosporin. Chemiotherapia. 1987; 6:329-36.

    256. Chin NX, Neu HC. Comparative in vitro activity and beta-lactamase stability of CGP 31523A, a new aminothiazolyl cephalosporin. Chemioterapia. 1986; 5:92-100. [PubMed 3518967]

    257. Vuram-Rapp U, Kayser FH, Barberis-Maino L. Antibacterial properties of imipenem with special reference to the activity against methicillin-resistant staphylococci, cefotaxime-resistant enterobacteriaceae and Pseudomonas aeruginosa. J Antimicrob Chemother. 1986; 18:27-33. [PubMed 3102452]

    258. Moellering RC Jr, Eliopoulos GM. Activity of cefotaxime against enterococci. Diagn Microbiol Infect Dis. 1984; 2(Suppl 3):85-90S. [PubMed 6232086]

    259. Winstanley TG, Spencer RC. An in vitro study of the interaction between cefotaxime and desacetylcefotaxime. Drugs Exp Clin Res. 1986; 12:967-71. [PubMed 3471432]

    260. Elliott AM, Karam GH, Cobbs CG. Interaction of cefotaxime and aminoglycosides against enterococci in vitro. Antimicrob Agents Chemother. 1983; 24:847-50. [IDIS 179228] [PubMed 6318661]

    261. Goldstein EJC, Citron DM. Comparative in vitro inhibitory and killing activity of cefpirome, ceftazidime, and cefotaxime against Pseudomonas aeruginosa, enterococci, Staphylococcus epidermidis, and methicillin-susceptible and -resistant and tolerant and nontolerant Staphylococcus aureus. Antimicrob Agents Chemother. 1985; 28:160-2. [IDIS 203416] [PubMed 3929677]

    262. Thornsberry C, Jones RN, Barry AL et al. Antimicrobial susceptibility tests with cefotaxime and correlation with clinical bacteriologic response. Rev Infect Dis. 1982; 4(Suppl):S316-24.

    263. Asmar Bi, Thirumoorthi MC, Buckley JA et al. Cefotaxime diffusion into cerebrospinal fluid of children with meningitis. Antimicrob Agents Chemother. 1985; 28:138-40. [IDIS 203411] [PubMed 4037772]

    264. Trang JM, Jacobs RF, Kearns GL et al. Cefotaxime and desacetylcefotaxime pharmacokinetics in infants and children with meningitis. Antimicrob Agents Chemother. 1985; 28:791-5. [IDIS 208812] [PubMed 4083862]

    265. Preac-Mursic V, Wilske B, Schierz G et al. In vitro and in vivo susceptibility of Borrelia burgdorferi. Eur J Clin Microbiol. 1987; 6:424-6. [PubMed 3665899]

    266. Hassler D, Zoller L, Haude M et al. Cefotaxime versus penicillin in the late stage of Lyme disease—prospective, randomized therapeutic study. Infection. 1990; 18:16-20. [PubMed 2179134]

    267. Pfister H-W, Preac-Mursic V, Wilske B et al. Cefotaxime vs penicillin G for acute neurologic manifestations in Lyme borreliosis. Arch Neurol. 1989; 46:1190-4. [PubMed 2684107]

    268. Abdel-Hag NM, Asmar BI, Abuhammour WM et al. Yersinia enterocolitica infection in children. Pediatr Infect Dis J. 2000; 19:954-8. [PubMed 11055595]

    269. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007; 44 Suppl 2:S27-72. [PubMed 17278083]

    270. Luft BJ, Gorevic PD, Halperin JJ et al. A perspective on the treatment of Lyme borreliosis. Rev Infect Dis. 1989; 11(Suppl 6):S1518-25.

    271. Neu HC. A perspective on therapy of Lyme infection. Ann NY Acad Sci. 1988; 539:314-6. [PubMed 3056200]

    272. Reviewers’ comments on Lyme disease revisions (personal observations). 1989 Dec 4.

    273. Anon. Treatment of Lyme Disease. Med Lett Drugs Ther. 2000; 42:37-9. [PubMed 10825919]

    274. Steere AC, Schoen RT, Taylor E. The clinical evolution of Lyme arthritis. Ann Intern Med. 1987; 107:725-31. [PubMed 3662285]

    275. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

    276. Anon. Prevalence of penicillin-resistant Streptococcus pneumoniae—Connecticut, 1992-1993. MMWR Morb Mortal Wkly Rep. 1994; 43:216,217,223. [PubMed 8127327]

    277. Leggiadro RJ. Penicillin- and cephalosporin-resistant Streptococcus pneumoniae: an emerging threat Pediatrics. 1994; 93:500-3.

    278. Baxter Healthcare Corporation. Descriptive information on premixed products. Deerfield, IL; 1994 Feb 21.

    279. Hofmann J, Cetron MS, Farley MM et al. The prevalence of drug-resistant Streptococcus pneumoniae in Atlanta. N Engl J Med. 1995; 333:481-6. [IDIS 351542] [PubMed 7623880]

    280. Pallares R, Linares J, Vadillo M et al. Resistance to penicillin and cephalosporin and mortality from severe pneumococcal pneumonia in Barcelona, Spain. N Engl J Med. 1995; 333:474-80. [IDIS 351541] [PubMed 7623879]

    281. Klass PE, Klein JO. Therapy of bacterial sepsis, meningitis and otitis media in infants and children: 1992 poll of directors of programs in pediatric infectious diseases. Pediatr Infect Dis J. 1992; 11:702-5. [PubMed 1448307]

    282. Feigin RD, McCracken GH, Klein JO. Diagnosis and management of meningitis. Pediatr Infect Dis J. 1992; 11:785-814. [PubMed 1448332]

    283. Sloas NM, Barrett FF, Chesney PJ et al. Cephalosporin treatment failures in penicillin- and cephalosporin-resistant Streptococcus pneumoniae meningitis. Pediatr Infect Dis J. 1992; 11:662-6. [PubMed 1523079]

    284. Sigal LH. Early disseminated Lyme disease: cardiac manifestations. Am J Med. 1995; 98(4A):25-8S.

    285. Sigal LH. Management of Lyme disease refractory to antibiotic therapy. Rheum Dis Clin North Am. 1995; 21:217-30. [PubMed 7732170]

    286. Spach DH, Liles WC, Campbell GL et al. Tick-borne diseases in the United States. N Engl J Med. 1993; 329:936-47. [IDIS 320338] [PubMed 8361509]

    287. Nadelman RB, Wormser GP. Erythema migrans and early Lyme disease. Am J Med. 1995; 98(4A):15-23S.

    288. Nau R, Prange HW, Muth P et al. Passage of cefotaxime and ceftriaxone into cerebrospinal fluid of patients with inflamed meninges. Antimicrob Agents Chemother. 1993; 37:1518-24. [IDIS 316800] [PubMed 8363385]

    289. Ko RJ, Sattler FR, Nichols S et al. Pharmacokinetics of cefotaxime and desacetylcefotaxime in patients with liver disease. Antimicrob Agents Chemother. 1991; 35:1376-80. [IDIS 284981] [PubMed 1929296]

    290. Todd PA, Brogden RN. Cefotaxime: an update of its pharmacology and therapeutic use. Drugs. 1990; 40:608-51. [PubMed 2083516]

    291. Jacobs RF, Darville T, Parks JA et al. Safety profile and efficacy of cefotaxime for the treatment of hospitalized children. Clin Infect Dis. 1992; 14:56-65. [IDIS 295049] [PubMed 1571464]

    292. Chuang YC, Liu JW, Ko WC et al. In vitro synergism between cefotaxime and minocycline against Vibrio vulnificus. Antimicrob Agents Chemother. 1997; 41:2214-7. [IDIS 395008] [PubMed 9333050]

    293. Chuang YC, Ko WC, Wang St et al. Minocycline and cefotaxime in the treatment of experimental murine Vibrio vulnificus infection. Antimicrob Agents Chemother. 1998; 42:1319-22. [PubMed 9624467]

    294. Kumamoto KS, Vukich DJ. Clinical infections of Vibrio vulnificus: a case report and review of the literature. J Emerg Med. 1998; 16:61-6. [PubMed 9472762]

    295. Anon. Vibrio vulnificus infections associated with raw oyster consumption—Florida, 1981-1992. MMWR Morb Mortal Wkly Rep. 1993; 42:405-7. [PubMed 8497241]

    296. Quagliarello VJ, Scheld WM. Treatment of bacterial meningitis. N Engl J Med. 1997; 336:708-16. [IDIS 388664] [PubMed 9041103]

    297. American Academy of Pediatrics Committee on Infectious Diseases. Therapy for children with invasive pneumococcal infections. Pediatrics. 1997; 99:289-99. [IDIS 381500] [PubMed 9024464]

    298. Walker CK, Kahn JG, Washington AE et al. Pelvic inflammatory disease: metaanalysis of antimicrobial regimen efficacy. J Infect Dis. 1993; 168:969-78. [IDIS 320603] [PubMed 8376843]

    299. Cunha BA. Treatment of pelvic inflammatory disease. Clin Pharm. 1990; 9:275-85. [IDIS 265474] [PubMed 2184973]

    300. Hemsell DL, Little BB, Faro S et al. Comparison of three regimens recommended by the Centers for Disease Control and Prevention for the treatment of women hospitalized with acute pelvic inflammatory disease. Clin Infect Dis. 1994; 19:720-7. [IDIS 337500] [PubMed 7803638]

    301. Adu A, Armour CL. Drug utilisation review (DUR) of the third generation cephalosporins: focus on ceftriaxone, ceftazidime and cefotaxime. Drugs. 1995; 50:423-39. [PubMed 8521766]

    302. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Saf. 1994; 10:318-27. [PubMed 8018304]

    303. Thompson JW, Jacobs RF. Adverse effects of newer cephalosporins: an update. Drug Saf. 1993; 9:132-42. [PubMed 8397890]

    304. Nataro JP. Treatment of bacterial enteritis. Pediatr Infect Dis J. 1998; 17:420-2. [IDIS 407084] [PubMed 9613658]

    305. Zenilman JM. Typhoid fever. JAMA. 1997; 278:847-50. [IDIS 391174] [PubMed 9293994]

    306. Soe GB, Overturf GD. Treatment of typhoid fever and other systemic salmonelloses with cefotaxime, ceftriaxone, cefoperazone, and other newer cephalosporins. Rev Infect Dis. 1987; 9:719-36. [IDIS 232251] [PubMed 3125577]

    307. Mermin JH, Townes JM, Gerber M et al. Typhoid fever in the United States, 1985-1994: changing risks of international travel and increasing antimicrobial resistance. Arch Intern Med. 1998; 158:633-8. [PubMed 9521228]

    308. Guerrero MLF, Ramos JM, Nunez A et al. Focal infections due to non-typhi Salmonella in patients with AIDS: report of 10 cases and review. Clin Infect Dis. 1997; 25:690-7. [IDIS 393737] [PubMed 9314463]

    309. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From HIV/AIDS Treatment Information Services (ATIS) website ().

    310. McClean KL, Sheehan GJ, Harding GKM. Intraabdominal infection: a review. Clin Infect Dis. 1994; 19:100-6. [IDIS 333128] [PubMed 7948510]

    311. Karam GH, Sanders CV, Aldridge KE. Role of newer antimicrobial agents in the treatment of mixed aerobic and anaerobic infections. Surg Gynecol Obstet. 1991; 172(Suppl):57-64. [IDIS 281378] [PubMed 2024228]

    312. Cormican MG, Jones RN. Antimicrobial activity of cefotaxime tested against infrequently isolated pathogenic species (unusual pathogens). Diagn Microbiol Infect Dis. 1995; 22:43-8. [PubMed 7587049]

    313. Gomez-Garces JL, Alos JI, Sanchez J et al. Bacteremia by multidrug-resistant Capnocytophaga sputigena. J Clin Microbiol. 1994; 32:1067-9. [PubMed 8027314]

    314. Hawkey PM, Smith SD, Hayes J et al. In vitro susceptibility of Capnocytophaga species to antimicrobial agents. Antimicrob Agents Chemother. 1987; 31:331-2. [PubMed 3566254]

    315. Rummen JL, Gordts B, Van Landuyt HW. In vitro susceptibility of Capnocytophaga species to 29 antimicrobial agents. Antimicrob Agents Chemother. 1986; 30:739-42. [PubMed 3800350]

    316. Pers C, Gahrn-Hanson B, Frederiksen W. Capnocytophaga canimorsus septicemia in Denmark, 1982-1995: review of 39 cases. Clin Infect Dis. 1996; 23:71-5. [PubMed 8816132]

    317. Pitkin DH, Sheikh W, Nadler HL. Comparative in vitro activity of meropenem versus other extended-spectrum antimicrobials against randomly chosen and selected resistant clinical isolates tested in 26 North American centers. Clin Infect Dis. 1997; 24(Suppl 2):S238-48.

    318. Tunkel AP, Scheld WM. Issues in the management of bacterial meningitis. Am Fam Physician. 1997; 56:1355-62. [IDIS 393071] [PubMed 9337758]

    319. Townsend GC, Scheld WM. Infections of the central nervous system. Adv Intern Med. 1998; 43:403-47. [PubMed 9506189]

    320. Paris MM, Ramilo I, McCracken GH. Management of meningitis caused by penicillin-resistant Streptococcus pneumoniae. Antimicrob Agents Chemother. 1995; 2171-5.

    321. Buchingham SC, Brown SP, San Joaquin VH. Breakthrough bacteremia and meningitis during treatment with cephalosporins parenterally for pneumococcal pneumonia. J Pediatr. 1998; 132:174-6. [IDIS 401044] [PubMed 9470026]

    322. Pacheco TR, Cooper CK, Hardy DJ et al. Failure of cefotaxime treatment in an adult with Streptococcus pneumoniae meningitis. Am J Med. 1997; 102:303-5. [IDIS 389050] [PubMed 9217602]

    323. Wubbel L, McCracken GH. Management of bacterial meningitis: 1998. Pediatr Rev. 1998; 19:78-84. [PubMed 9509854]

    324. McIntyre PB, Berkey CS, King SM et al. Dexamethasone as adjunctive therapy in bacterial meningitis: a meta-analysis of randomized clinical trials since 1988. JAMA. 1997; 278:925-31. [IDIS 391326] [PubMed 9302246]

    325. Chesney PJ, Halsey NA, Marcy SM. Treatment of bacterial meningitis. N Engl J Med. 1997; 337:793-4. [IDIS 390965] [PubMed 9289652]

    326. Quagliarello V, Scheld WM. Treatment of bacterial meningitis. N Engl J Med. 1997; 337:794. [IDIS 390967] [PubMed 9289653]

    327. Bhattacharya S. Management of meningitis caused by penicillin-resistant Streptococcus pneumoniae. Antimicrob Agents Chemother. 1996; 40:827-8. [IDIS 364393] [PubMed 8851626]

    328. Ahmed A. A critical evaluation of vancomycin for treatment of bacterial meningitis. Pediatr Infect Dis J. 1997; 16:895-903. [IDIS 392888] [PubMed 9306486]

    329. Kleiman MB, Weinberg GA, Reynolds JK et al. Meningitis with beta-lactam-resistant Streptococcus pneumoniae: the need for early repeat lumbar puncture. Pediatr Infect Dis J. 1993; 12:782-4. [PubMed 8414810]

    330. Centers for Disease Control and Prevention. Drug-resistant Streptococcus pneumoniae—Kentucky and Tennessee, 1993. MMWR Morb Mortal Wkly Rep. 1994; 43:23-7. [IDIS 324201] [PubMed 8277937]

    331. Friedland IR, Shelton S, Paris M et al. Dilemmas in diagnosis and management of cephalosporin-resistant Streptococcus pneumoniae meningitis. Pediatr Infect Dis J. 1993; 12:196-200. [PubMed 8451095]

    332. Chesney PJ. The escalating problem of antimicrobial resistance in Streptococcus pneumoniae. Am J Dis Child. 1992; 146:912-6. [IDIS 300056] [PubMed 1636656]

    333. John CC. Treatment failure with use of a third-generation cephalosporin for penicillin-resistant pneumococcal meningitis: case report and review. Clin Infect Dis. 1994; 18:188-93. [IDIS 325352] [PubMed 8161625]

    334. Hofmann J, Cetron MS, Farley MM et al. The prevalence of drug-resistant Streptococcus pneumoniae in Atlanta. N Engl J Med. 1995; 333:481-6. [IDIS 351542] [PubMed 7623880]

    335. Viladrich PF, Cabellos C, Pallares R et al. High doses of cefotaxime in treatment of adult meningitis due to Streptococcus pneumoniae with decreased susceptibilities to broad-spectrum cephalosporins. Antimicrob Agents Chemother. 1996; 40:218-20. [IDIS 361527] [PubMed 8787909]

    336. Sjolin J, Lilja A, Eriksson N et al. Treatment of brain abscess with cefotaxime and metronidazole: prospective study on 15 consecutive patients. Clin Infect Dis. 1993; 17:857-63. [IDIS 321794] [PubMed 8286626]

    338. Nadelman RB, Wormser GP. Lyme borreliosis. Lancet. 1998; 352:557-65. [IDIS 415637] [PubMed 9716075]

    340. Rahn DW, Felz MW. Lyme disease update. Current approach to early, disseminated, and late disease. Postgrad Med. 1998; 103:51-4, 57-9, 63-4. [IDIS 405540] [PubMed 9590986]

    341. Luft BJ. Treatment of erythema migrans. Ann Intern Med. 1997; 126:408-9.

    342. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]

    343. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

    344. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

    345. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

    346. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]

    347. Mathisen GE, Johnson JP. Brain abscess. Clin Infect Dis. 1997; 25:763-81. [IDIS 395783] [PubMed 9356788]

    348. Reviewers’ comments (personal observations).

    349. Sobraques M, Maurin M, Birtles RJ et al. In vitro susceptibilities of four Bartonella bacilliformis strains to 30 antibiotic compounds. Antimicrob Agents Chemother. 1999; 43:2090-2. [IDIS 433952] [PubMed 10428946]

    350. Aracil B, Gomez-Garces JL, Alos JI. A study of susceptibility of 100 clinical isolates belonging to the Streptococcus milleri group to 16 cephalosporins. J Antimicrob Chemother. 1999; 43:399-402. [IDIS 425875] [PubMed 10223596]

    351. Wormser GP, Dattwyler RJ, Shapiro ED et al. The clinical assessment, treatment, and prevention of lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2006; 43:1089-134. [PubMed 17029130]

    352. Heffelfinger JD, Dowell SF, Jorgensen JH et al. Management of community-acquired pneumonia in the era of pneumococcal resistance. A report from the drug-resistant Streptococcus pneumoniae therapeutic working group. Arch Intern Med. 2000; 160:1399-1408. [IDIS 448719] [PubMed 10826451]

    353. Nocton JJ, Steere AC. Lyme disease. Adv Intern Med. 1995; 40:69-117. [PubMed 7747659]

    354. Steere AC. Lyme disease. N Engl J Med. 2001; 345:115-25. [IDIS 467351] [PubMed 11450660]

    355. Steere AC. Musculoskeletal manifestations of Lyme disease. Am J Med. 1995; 98(4A):44-48S.

    356. Shapiro ED. Lyme disease in children. Am J Med. 1995; 98(4A):69-73S.

    357. Pachner AR. Early disseminated Lyme disease: Lyme meningitis. Am J Med. 1995; 98(4A):30-37S.

    358. Klempner MS, Hu LT, Evans J et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med. 2001; 345:85-92. [IDIS 467349] [PubMed 11450676]

    359. Patel R, Grogg KL, Edwards WD et al. Death from inappropriate therapy for Lyme disease. Clin Infect Dis. 2000; 31:1107-9. [IDIS 456009] [PubMed 11049799]

    360. Centers for Disease Control and Prevention. Ceftriaxone-associated biliary complications of treatment of suspected disseminated Lyme disease—New Jersey, 1990-1992. MMWR Morb Mortal Wkly Rep. 1993; 42:39-42. [PubMed 8419791]

    361. Thompson C, Spielman A, Krause P. Coinfecting deer-associated zoonoses: Lyme disease, babesiosis, and ehrlichiosis. Clin Infect Dis. 2000; 33:676-85.

    362. Luft BJ, Gardner P, Lightfoot RW Jr. Appropriateness of parenteral antibiotic treatment for patients with presumed Lyme disease. Ann Intern Med. 1993; 119:518. [PubMed 8357119]

    363. Lightfoot RW, Luft BJ, Rahn DW et al. Empiric parenteral antibiotic treatment of patients with fibromyalgia and fatigue and a positive serologic result for Lyme disease. A cost-effectiveness analysis. Ann Intern Med. 1993; 119:503-9. [IDIS 320377] [PubMed 8357117]

    364. Ettestad PJ, Campbell GL, Welbel SF et al. Biliary complications in the treatment of unsubstantiated Lyme disease. J Infect Dis. 1995; 171:356-61. [IDIS 342008] [PubMed 7844372]

    365. Tunkel AR, Hartman BJ, Kaplan SL et al. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004; 39:1267-84. [IDIS 537717] [PubMed 15494903]

    366. American Pharmaceutical Partners, Inc. Cefotaxime for injection, USP prescribing information. Schaumburg, IL. 2004 Nov.

    367. American Pharmaceutical Partners, Inc. Cefotaxime for injection, USP pharmacy bulk package prescribing information. Schaumburg, IL. 2004 Nov.

    368. Pfister HW, Preac-Mursic V, Wilske B et al. Randomized comparison of ceftriaxone and cefotaxime in Lyme neuroborreliosis. J Infect Dis. 1991; 163:311-8. [PubMed 1988514]

    369. Centers for Disease Control and Prevention. Updated recommended treatment regimens for gonococcal infections and associated conditions—United States, April 2007. From CDC website (). Accessed 2007 April 12.

    a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.

    b. AHFS Drug Information 2003. McEvoy GK, ed. Cefotaxime. American Society of Health-System Pharmacists; 2003:168-78.

    HID. Trissel LA. Handbook on injectable drugs. 13th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:296-303.

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    Claforan

    Claforan

    Generic Name: cefotaxime (SEF oh TAX eem)

    Brand Name: Claforan

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Claforan (cefotaxime)?

    Cefotaxime is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

    Cefotaxime is used to treat many kinds of bacterial infections, including severe or life-threatening forms. Cefotaxime is also used to prevent infections in people having surgery.

    Cefotaxime may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about Claforan (cefotaxime)?

    You should not use this medication if you are allergic to cefotaxime or to similar antibiotics, such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

    Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, diabetes, a stomach or intestinal disorder, or a heart rhythm disorder.

    Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefotaxime will not treat a viral infection such as the common cold or flu.

    Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

    This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using cefotaxime.

    What should I discuss with my health care provider before using Claforan (cefotaxime)?

    You should not use this medication if you are allergic to cefotaxime, or to other cephalosporin antibiotics, such as:

    • cefaclor (Raniclor);

    • cefadroxil (Duricef);
    • cefazolin (Ancef);
    • cefdinir (Omnicef);
    • cefditoren (Spectracef);
    • cefpodoxime (Vantin);
    • cefprozil (Cefzil);
    • ceftibuten (Cedax);
    • cefuroxime (Ceftin);
    • cephalexin (Keflex); or
    • cephradine (Velosef).

    To make sure you can safely use cefotaxime, tell your doctor if you have any of these other conditions:

    • allergy to penicillin;

    • kidney disease;
    • liver disease;
    • a stomach or intestinal disorder such as colitis;
    • diabetes; or
    • a heart rhythm disorder.

    FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

    Cefotaxime can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I use Claforan (cefotaxime)?

    Cefotaxime is injected into a muscle or into a vein through an IV. It is sometimes given through a central IV line placed into a large vein in your chest. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

    Cefotaxime must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

    Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

    Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Cefotaxime will not treat a viral infection such as the common cold or flu.

    This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using cefotaxime.

    If your medicine is frozen when you receive it, keep it frozen until you are ready to use the medicine. It is best to store the medicine in a deep freezer at a temperature of 4 degrees below 0.

    To use the medicine, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Keep thawed medicine in the refrigerator and use it within 10 days after thawing it. Do not refreeze thawed medicine.

    What happens if I miss a dose?

    Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

    If you are receiving this medication at a clinic, call your doctor if you miss an appointment for your injection.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    Overdose symptoms may include weakness, cold feeling, pale skin, blue lips, or seizure (convulsions).

    What should I avoid while using Claforan (cefotaxime)?

    Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using cefotaxime and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

    Claforan (cefotaxime) side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have a serious side effect such as:

    • diarrhea that is watery or bloody;

    • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
    • uneven heartbeats;
    • fever, chills, body aches, flu symptoms;
    • easy bruising or bleeding, unusual weakness;
    • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
    • seizure (black-out or convulsions); or
    • jaundice (yellowing of the eyes or skin).

    Less serious side effects may include:

    • pain, irritation, or a hard lump where the injection was given;

    • stomach pain, nausea, vomiting;
    • headache; or
    • vaginal itching or discharge.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Claforan side effects (in more detail)

    What other drugs will affect Claforan (cefotaxime)?

    Tell your doctor about all other medicines you use, especially:

    • probenecid (Benemid); or

    • any other injected antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or tobramycin (Nebcin, Tobi).

    This list is not complete and other drugs may interact with cefotaxime. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

    More Claforan resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Interactions
    • Support Group
    • 0 Reviews - Add your own review/rating
    • Generic Availability
    • Claforan Prescribing Information (FDA)
    • Claforan MedFacts Consumer Leaflet (Wolters Kluwer)
    • Claforan Monograph (AHFS DI)
    • Claforan Advanced Consumer (Micromedex) – Includes Dosage Information
    • Cefotaxime Prescribing Information (FDA)

    Compare Claforan with other medications

    • Bacteremia
    • Bone infection
    • Cesarean Section
    • CNS Infection
    • Endometritis
    • Epiglottitis
    • Gonococcal Infection, Disseminated
    • Gonococcal Infection, Uncomplicated
    • Intraabdominal Infection
    • Joint Infection
    • Kidney Infections
    • Lyme Disease
    • Lyme Disease, Arthritis
    • Lyme Disease, Carditis
    • Lyme Disease, Neurologic
    • Meningitis
    • Pelvic Inflammatory Disease
    • Peritonitis
    • Pneumonia
    • Salmonella Gastroenteritis
    • Sepsis
    • Septicemia
    • Skin Infection
    • Surgical Prophylaxis
    • Urinary Tract Infection

    Where can I get more information?

    • Your pharmacist can provide more information about cefotaxime.

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