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Ceftin

Ceftin(cefuroxime axetil) – GlaxoSmithKline

THERAPEUTIC CLASS

Cephalosporin (2nd generation)

INDICATIONS

Treatment of the following infections caused by susceptible strains of microorganisms: (Sus/Tab) Pharyngitis/tonsillitis and acute otitis media. (Sus) Impetigo. (Tab) Uncomplicated skin and skin structure infections (SSSI), uncomplicated urinary tract infections (UTI), uncomplicated gonorrhea, early Lyme disease, acute bacterial maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis (ABECB), and secondary bacterial infections of acute bronchitis.

ADULT DOSAGE

Adults: (Tab) Pharyngitis/Tonsillitis/Sinusitis: 250mg bid for 10 days. ABECB/SSSI: 250-500mg bid for 10 days. Acute Bronchitis: 250-500mg bid for 5-10 days. UTI: 250mg bid for 7-10 days. Gonorrhea: 1000mg single dose. Lyme Disease: 500mg bid for 20 days.

PEDIATRIC DOSAGE

Pediatrics: ≥13 yrs: (Tab) Pharyngitis/Tonsillitis/Sinusitis: 250mg bid for 10 days. ABECB/SSSI: 250-500mg bid for 10 days. Acute Bronchitis: 250-500mg bid for 5-10 days. UTI: 250mg bid for 7-10 days. Gonorrhea: 1000mg single dose. Lyme Disease: 500mg bid for 20 days. 3 months-12 yrs: (Sus) Pharyngitis/Tonsillitis: 20mg/kg/day divided bid for 10 days. Max: 500mg/day. Otitis Media/Sinusitis/Impetigo: 30mg/kg/day divided bid for 10 days. Max: 1000mg/day. (Tab-if can swallow whole) Otitis Media/Sinusitis: 250mg bid for 10 days.

HOW SUPPLIED

Sus: 125mg/5mL [100mL], 250mg/5mL [50mL, 100mL]; Tab: 250mg, 500mg

WARNINGS/PRECAUTIONS

Tabs are not bioequivalent to sus. Caution in patients with previous hypersensitivity to penicillins (PCNs) or other drugs; cross-sensitivity may occur in patients with a history of PCN allergy. D/C if an allergic reaction occurs. Watery, bloody stools (with or without stomach cramps and fever) may develop after starting treatment. 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. May cause fall in PT; those at risk include patients previously stable on anticoagulants, patients receiving protracted course of antibiotics, patients with renal/hepatic impairment, and patients in a poor nutritional state. Monitor PT and give vitamin K as needed. Safety and efficacy not established in patients with renal failure. Lab test interactions may occur. (Sus) Contains phenylalanine.

ADVERSE REACTIONS

Diarrhea, N/V, vaginitis, (suspension) dislike of taste, diaper rash.

DRUG INTERACTIONS

Probenecid increases plasma levels. Lower bioavailability with drugs that lower gastric acidity. Caution with agents causing adverse effects on renal function (diuretics). May lower estrogen reabsorption and reduce the efficacy of combined oral estrogen/progesterone contraceptives.

PREGNANCY

Category B, not for use in nursing.

MECHANISM OF ACTION

2nd-generation cephalosporin; binds to essential target proteins and the resultant inhibition of cell-wall synthesis.

PHARMACOKINETICS

Absorption: Absolute bioavailability (37% before food), (52% after food). PO administration of variable doses resulted in different parameters. Distribution: Plasma protein binding (50%); found in breast milk. Metabolism: Rapid hydrolysis, via nonspecific esterases in the intestinal mucosa and blood. Elimination: Urine (50% unchanged).

ASSESSMENT

Assess for previous hypersensitivity reactions to cephalosporins/PCNs or other drugs, renal/hepatic impairment, nutritional state, history of colitis, GI malabsorption, pregnancy/nursing status, and for possible drug interactions. For patients planning on using sus formulation, assess for phenylketonuria.

MONITORING

Monitor signs/symptoms of an allergic reaction, CDAD, and superinfection. Monitor PT and renal function.

PATIENT COUNSELING

Advise of potential benefits/risks of therapy. Inform that drug only treats bacterial, not viral infections. Instruct to take exactly as directed; skipping doses or not completing full course may decrease effectiveness and increase resistance. Counsel to d/c and notify physician if an allergic reaction or if watery/bloody diarrhea (with/without stomach cramps or fever) develop. Instruct to notify physician if pregnant/nursing. Inform caregivers of pediatric patients that if cannot swallow tab whole, should receive oral sus. Advise that crushed tab, has a strong/persistent bitter taste. Inform that tab may be administered without regard to meals but oral sus must be administered with food.

ADMINISTRATION/STORAGE

Administration: Oral route. Tab and sus not bioequivalent and not substitutable on mg-per-mg basis. Refer to PI for reconstitution instructions for sus. Shake sus well before use. Storage: Tab: Store at 15-30°C (59-86°F). Sus Powder: Store at 2-30°C (36-86°F). Reconstituted Sus: Store at 2-8°C (36-46°F) in a refrigerator; discard after 10 days.


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    Ceftin

    Ceftin

    Pronunciation Generic Name: cefuroxime axetil

    Dosage Form: tablet, film coated – powder, for suspension

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Ceftin® Tablets

    (cefuroxime axetil tablets)

    Ceftin® for Oral Suspension

    (cefuroxime axetil powder for oral suspension)

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

    Ceftin Description

    Ceftin Tablets and Ceftin for Oral Suspension contain cefuroxime as cefuroxime axetil. Ceftin is a semisynthetic, broad-spectrum cephalosporin antibiotic for oral administration.

    Chemically, cefuroxime axetil, the 1-(acetyloxy) ethyl ester of cefuroxime, is (RS)-1-hydroxyethyl (6R ,7R) – 7 – [2 - (2 - furyl)glyoxyl - amido] – 3 – (hydroxymethyl) – 8 – oxo – 5 – thia – 1 – azabicyclo[4.2.0] – oct – 2 – ene – 2 – carboxylate, 72-(Z)-(O -methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48.

    Cefuroxime axetil is in the amorphous form and has the following structural formula:

    Ceftin Tablets are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Ceftin Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate, sodium lauryl sulfate, and titanium dioxide.

    Ceftin for Oral Suspension, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. Ceftin for Oral Suspension contains the inactive ingredients acesulfame potassium, aspartame, povidone K30, stearic acid, sucrose, tutti-frutti flavoring, and xanthan gum.

    Ceftin – Clinical Pharmacology

    Absorption and Metabolism

    After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime. Cefuroxime is subsequently distributed throughout the extracellular fluids. The axetil moiety is metabolized to acetaldehyde and acetic acid.

    Pharmacokinetics

    Approximately 50% of serum cefuroxime is bound to protein. Serum pharmacokinetic parameters for Ceftin Tablets and Ceftin for Oral Suspension are shown in Tables 1 and 2.

    Table 1. Postprandial Pharmacokinetics of Cefuroxime Administered as Ceftin Tablets to Adultsa
    Doseb

    (Cefuroxime

    Equivalent)

    Peak Plasma Concentration

    (mcg/mL)

    Time of Peak Plasma Concentration (hr)

    Mean

    Elimination

    Half-life (hr)

    AUC

    (mcg•hr/mL)

    125 mg

    2.1

    2.2

    1.2

    6.7

    250 mg

    4.1

    2.5

    1.2

    12.9

    500 mg

    7.0

    3.0

    1.2

    27.4

    1,000 mg

    13.6

    2.5

    1.3

    50.0

    a  Mean values of 12 healthy adult volunteers.

    b  Drug administered immediately after a meal.

    Table 2. Postprandial Pharmacokinetics of Cefuroxime Administered as Ceftin for Oral Suspension to Pediatric Patientsa
    Doseb

    (Cefuroxime

    Equivalent)

    n

    Peak Plasma

    Concentration

    (mcg/mL)

    Time of Peak

    Plasma

    Concentration (hr)

    Mean

    Elimination

    Half-life

    (hr)

    AUC

    (mcg•hr/mL)

    10 mg/kg

    8

    3.3

    3.6

    1.4

    12.4

    15 mg/kg

    12

    5.1

    2.7

    1.9

    22.5

    20 mg/kg

    8

    7.0

    3.1

    1.9

    32.8

    a  Mean age = 23 months.

    b  Drug administered with milk or milk products.

    Comparative Pharmacokinetic Properties

    A 250 mg/5 mL-dose of Ceftin Suspension is bioequivalent to 2 times 125 mg/5 mL-dose of Ceftin Suspension when administered with food (see Table 3). Ceftin for Oral Suspension was not bioequivalent to Ceftin Tablets when tested in healthy adults. The tablet and powder for oral suspension formulations are NOT substitutable on a milligram-per-milligram basis. The area under the curve for the suspension averaged 91% of that for the tablet, and the peak plasma concentration for the suspension averaged 71% of the peak plasma concentration of the tablets. Therefore, the safety and effectiveness of both the tablet and oral suspension formulations had to be established in separate clinical trials.

    Table 3. Pharmacokinetics of Cefuroxime Administered as 250 mg/5 mL or 2 x 125 mg/5 mL Ceftin for Oral Suspension to Adultsa With Food
    Dose

    (Cefuroxime

    Equivalent)

    Peak Plasma Concentration

    (mcg/mL)

    Time of Peak

    Plasma

    Concentration (hr)

    Mean Elimination

    Half-life (hr)

    AUC

    (mcg•hr/mL)

    250 mg/5 mL

    2.23

    3

    1.40

    8.92

    2 x 125 mg/5 mL

    2.37

    3

    1.44

    9.75

    a  Mean values of 18 healthy adult volunteers.

    Food Effect on Pharmacokinetics

    Absorption of the tablet is greater when taken after food (absolute bioavailability of Ceftin Tablets increases from 37% to 52%). Despite this difference in absorption, the clinical and bacteriologic responses of patients were independent of food intake at the time of tablet administration in 2 studies where this was assessed.

    All pharmacokinetic and clinical effectiveness and safety studies in pediatric patients using the suspension formulation were conducted in the fed state. No data are available on the absorption kinetics of the suspension formulation when administered to fasted pediatric patients.

    Renal Excretion

    Cefuroxime is excreted unchanged in the urine; in adults, approximately 50% of the administered dose is recovered in the urine within 12 hours. The pharmacokinetics of cefuroxime in the urine of pediatric patients have not been studied at this time. Until further data are available, the renal pharmacokinetic properties of cefuroxime axetil established in adults should not be extrapolated to pediatric patients.

    Because cefuroxime is renally excreted, the serum half-life is prolonged in patients with reduced renal function. In a study of 20 elderly patients (mean age = 83.9 years) having a mean creatinine clearance of 34.9 mL/min, the mean serum elimination half-life was 3.5 hours. Despite the lower elimination of cefuroxime in geriatric patients, dosage adjustment based on age is not necessary (see PRECAUTIONS: Geriatric Use).

    Microbiology

    The in vivo bactericidal activity of cefuroxime axetil is due to cefuroxime’s binding to essential target proteins and the resultant inhibition of cell-wall synthesis.

    Cefuroxime has bactericidal activity against a wide range of common pathogens, including many beta-lactamase−producing strains. Cefuroxime is stable to many bacterial beta-lactamases, especially plasmid-mediated enzymes that are commonly found in enterobacteriaceae.

    Cefuroxime has been demonstrated to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE (see INDICATIONS AND USAGE).

    Aerobic Gram-Positive Microorganisms Staphylococcus aureus (including beta­lactamase−producing strains)

    Streptococcus pneumoniae

    Streptococcus pyogenes

    Aerobic Gram-Negative Microorganisms Escherichia coli

    Haemophilus influenzae (including beta­lactamase−producing strains)

    Haemophilus parainfluenzae

    Klebsiella pneumoniae

    Moraxella catarrhalis (including beta­lactamase−producing strains)

    Neisseria gonorrhoeae (including beta­lactamase−producing strains)

    Spirochetes Borrelia burgdorferi

    Cefuroxime has been shown to be active in vitro against most strains of the following microorganisms; however, the clinical significance of these findings is unknown.

    Cefuroxime exhibits in vitro minimum inhibitory concentrations (MICs) of 4.0 mcg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of cefuroxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.

    Aerobic Gram-Positive Microorganisms Staphylococcus epidermidis

    Staphylococcus saprophyticus

    Streptococcus agalactiae

    NOTE: Listeria monocytogenes and certain strains of enterococci, e.g., Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillin-resistant staphylococci are resistant to cefuroxime.

    Aerobic Gram-Negative Microorganisms Morganella morganii

    Proteus inconstans

    Proteus mirabilis

    Providencia rettgeri

    NOTE: Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Legionella spp., and most strains of Serratia spp. and Proteus vulgaris are resistant to most first- and second-generation cephalosporins. Some strains of Morganella morganii, Enterobacter cloacae, and Citrobacter spp. have been shown by in vitro tests to be resistant to cefuroxime and other cephalosporins.

    Anaerobic Microorganisms Peptococcus niger

    NOTE: Most strains of Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime.

    Susceptibility Tests

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

    MIC (mcg/mL)

    Interpretation

    ≤4

    (S) Susceptible

    8-16

    (I) Intermediate

    ≥32

    (R) Resistant

    A report of “Susceptible” indicates that the pathogen, if in the blood, is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in blood. A report of “Intermediate” indicates that inhibitory concentrations of the antibiotic may be achieved if high dosage is used or if the infection is confined to tissues or fluids in which high antibiotic concentrations are attained. 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 usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.

    Standardized susceptibility test procedures require the use of laboratory control microorganisms. Standard cefuroxime powder should give the following MIC values:

    Microorganism

    MIC (mcg/mL)

    Escherichia coli ATCC 25922

    2-8

    Staphylococcus aureus ATCC 29213

    0.5-2

    Diffusion Techniques Quantitative methods that require measurement of zone diameters provide estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 that has been recommended (for use with disks) to test the susceptibility of microorganisms to cefuroxime uses the 30-mcg cefuroxime disk. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cefuroxime.

    Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-mcg cefuroxime disk should be interpreted according to the following criteria:

    Zone Diameter (mm)

    Interpretation

    ≥23

    (S) Susceptible

    15-22

    (I) Intermediate

    ≤14

    (R) Resistant

    Interpretation should be as stated above for results using dilution techniques.

    As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms. The 30-mcg cefuroxime disk provides the following zone diameters in these laboratory test quality control strains:

    Microorganism

    Zone Diameter (mm)

    Escherichia coli ATCC 25922

    20-26

    Staphylococcus aureus ATCC 25923

    27-35

    Indications and Usage for Ceftin

    NOTE: Ceftin TABLETS AND Ceftin FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

    Ceftin Tablets

    Ceftin Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

    1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Ceftin Tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.

    2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase−producing strains), Moraxella catarrhalis (including beta-lactamase−producing strains), or Streptococcus pyogenes.
    3. Acute Bacterial Maxillary Sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase−producing strains only) (see CLINICAL STUDIES). NOTE: In view of the insufficient numbers of isolates of beta-lactamase−producing strains of Haemophilus influenzae and Moraxella catarrhalis that were obtained from clinical trials with Ceftin Tablets for patients with acute bacterial maxillary sinusitis, it was not possible to adequately evaluate the effectiveness of Ceftin Tablets for sinus infections known, suspected, or considered potentially to be caused by beta-lactamase−producing Haemophilus influenzae or Moraxella catarrhalis.
    4. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta­lactamase negative strains) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
    5. Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including beta-lactamase−producing strains) or Streptococcus pyogenes.
    6. Uncomplicated Urinary Tract Infections caused by Escherichia coli or Klebsiella pneumoniae.
    7. Uncomplicated Gonorrhea, urethral and endocervical, caused by penicillinase-producing and non-penicillinase−producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase−producing strains of Neisseria gonorrhoeae.
    8. Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

    Ceftin for Oral Suspension

    Ceftin for Oral Suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. The safety and effectiveness of Ceftin for Oral Suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well­controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen.

    1. Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Ceftin for Oral Suspension is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. Please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. There are no data from adequate and well-controlled trials to demonstrate the effectiveness of cefuroxime in the treatment of penicillin-resistant strains of Streptococcus pyogenes.

    2. Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase−producing strains), Moraxella catarrhalis (including beta-lactamase−producing strains), or Streptococcus pyogenes.
    3. Impetigo caused by Staphylococcus aureus (including beta-lactamase−producing strains) or Streptococcus pyogenes.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftin and other antibacterial drugs, Ceftin 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.

    Contraindications

    Ceftin products are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

    Warnings

    Ceftin TABLETS AND Ceftin FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

    BEFORE THERAPY WITH Ceftin PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Ceftin PRODUCTS, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA­LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO Ceftin PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

    Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ceftin, 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 2 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

    As with other broad-spectrum antibiotics, prolonged administration of cefuroxime axetil may result in overgrowth of nonsusceptible microorganisms. If superinfection occurs during therapy, appropriate measures should be taken.

    Cephalosporins, including cefuroxime axetil, should be given with caution to patients receiving concurrent treatment with potent diuretics because these diuretics are suspected of adversely affecting renal function.

    Cefuroxime axetil, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety and effectiveness of cefuroxime axetil have not been established in patients with gastrointestinal malabsorption. Patients with gastrointestinal malabsorption were excluded from participating in clinical trials of cefuroxime axetil.

    Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.

    Prescribing Ceftin 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.

    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 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

    Information for Patients/Caregivers (Pediatric)

    Phenylketonurics Ceftin for Oral Suspension 125 mg/5 mL contains phenylalanine 11.8 mg per 5 mL (1 teaspoonful) constituted suspension. Ceftin for Oral Suspension 250 mg/5 mL contains phenylalanine 25.2 mg per 5 mL (1 teaspoonful) constituted suspension.

    1. During clinical trials, the tablet was tolerated by pediatric patients old enough to swallow the cefuroxime axetil tablet whole. The crushed tablet has a strong, persistent, bitter taste and should not be administered to pediatric patients in this manner. Pediatric patients who cannot swallow the tablet whole should receive the oral suspension.
    2. Discontinuation of therapy due to taste and/or problems of administering this drug occurred in 1.4% of pediatric patients given the oral suspension. Complaints about taste (which may impair compliance) occurred in 5% of pediatric patients.
    3. Patients should be counseled that antibacterial drugs, including Ceftin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ceftin 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 Ceftin or other antibacterial drugs in the future.

    Drug/Laboratory Test Interactions

    A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict’s or Fehling’s solution or with CLINITEST® tablets), but not with enzyme-based tests for glycosuria (e.g., CLINISTIX®). As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.

    Drug/Drug Interactions

    Concomitant administration of probenecid with cefuroxime axetil tablets increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after a 1.5-g single dose is greater when taken with 1 g of probenecid (mean = 14.8 mcg/mL) than without probenecid (mean = 12.2 mcg/mL).

    Drugs that reduce gastric acidity may result in a lower bioavailability of Ceftin compared with that of fasting state and tend to cancel the effect of postprandial absorption.

    In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity was found for cefuroxime axetil in a battery of bacterial mutation tests. Positive results were obtained in an in vitro chromosome aberration assay; however, negative results were found in an in vivo micronucleus test at doses up to 1.5 g/kg. Reproduction studies in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) have revealed no impairment of fertility.

    Pregnancy

    Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 3,200 mg/kg/day (14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Labor and Delivery

    Cefuroxime axetil has not been studied for use during labor and delivery.

    Nursing Mothers

    Because cefuroxime is excreted in human milk, consideration should be given to discontinuing nursing temporarily during treatment with cefuroxime axetil.

    Pediatric Use

    The safety and effectiveness of Ceftin have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Use of Ceftin in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled studies of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. It is also supported by postmarketing adverse events surveillance (see CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, and CLINICAL STUDIES).

    Geriatric Use

    Of the total number of subjects who received cefuroxime axetil in 20 clinical studies of Ceftin, 375 were 65 and older while 151 were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects.The geriatric patients reported somewhat fewer gastrointestinal events and less frequent vaginal candidiasis compared with patients aged 12 to 64 years old; however, no clinically significant differences were reported between the elderly and younger adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

    Adverse Reactions

    Ceftin TABLETS IN CLINICAL TRIALS

    Multiple-Dose Dosing Regimens 7 to 10 Days Dosing Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse events increased with the higher recommended doses.

    The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

    Table 4. Adverse Reactions–Ceftin Tablets

    Multiple-Dose Dosing Regimens–Clinical Trials
    Incidence ≥1%

    Diarrhea/loose stools 3.7%

    Nausea/vomiting 3.0%

    Transient elevation in AST 2.0%

    Transient elevation in ALT 1.6%

    Eosinophilia 1.1%

    Transient elevation in LDH 1.0%

    Incidence

    <1% but >0.1%

    Abdominal pain

    Abdominal cramps

    Flatulence

    Indigestion

    Headache

    Vaginitis

    Vulvar itch

    Rash

    Hives

    Itch

    Dysuria

    Chills

    Chest pain

    Shortness of breath

    Mouth ulcers

    Swollen tongue

    Sleepiness

    Thirst

    Anorexia

    Positive Coombs test

    5-Day Experience (see CLINICAL STUDIES) In clinical trials using Ceftin in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

    In Clinical Trials for Early Lyme Disease With 20 Days Dosing Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days dosing.

    Single-Dose Regimen for Uncomplicated Gonorrhea

    In clinical trials using a single dose of cefuroxime axetil tablets, 1,061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

    The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000-mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.

    Table 5. Adverse Reactions–Ceftin Tablets

    1-g Single-Dose Regimen for Uncomplicated Gonorrhea—Clinical Trials
    Incidence ≥1%

    Nausea/vomiting 6.8%

    Diarrhea 4.2%

    Incidence

    <1% but >0.1%

    Abdominal pain

    Dyspepsia

    Erythema

    Rash

    Pruritus

    Vaginal candidiasis

    Vaginal itch

    Vaginal discharge

    Headache

    Dizziness

    Somnolence

    Muscle cramps

    Muscle stiffness

    Muscle spasm of neck

    Tightness/pain in chest

    Bleeding/pain in urethra

    Kidney pain

    Tachycardia

    Lockjaw-type reaction

    Ceftin FOR ORAL SUSPENSION IN CLINICAL TRIALS

    In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven US patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.

    The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated US patients).

    Table 6. Adverse Reactions—Ceftin for Oral Suspension

    Multiple-Dose Dosing Regimens—Clinical Trials
    Incidence ≥1%

    Diarrhea/loose stools 8.6%

    Dislike of taste 5.0%

    Diaper rash 3.4%

    Nausea/vomiting 2.6%

    Incidence

    <1% but >0.1%

    Abdominal pain

    Flatulence

    Gastrointestinal infection

    Candidiasis

    Vaginal irritation

    Rash

    Hyperactivity

    Irritable behavior

    Eosinophilia

    Positive direct Coombs test

    Elevated liver enzymes

    Viral illness

    Upper respiratory infection

    Sinusitis

    Cough

    Urinary tract infection

    Joint swelling

    Arthralgia

    Fever

    Ptyalism

    POSTMARKETING EXPERIENCE WITH Ceftin

    In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with Ceftin Tablets or with Ceftin for Oral Suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

    General The following hypersensitivity reactions have been reported: Anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.

    Gastrointestinal Pseudomembranous colitis (see WARNINGS).

    Hematologic Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

    Hepatic Hepatic impairment including hepatitis and cholestasis, jaundice.

    Neurologic Seizure.

    Skin Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    Urologic Renal dysfunction.

    CEPHALOSPORIN-CLASS ADVERSE REACTIONS

    In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis.

    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

    Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

    Ceftin Dosage and Administration

    NOTE: Ceftin TABLETS AND Ceftin FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY).

    Table 7. Ceftin Tablets

    (May be administered without regard to meals.)
    Population/Infection

    Dosage

    Duration (days)

    Adolescents and Adults (13 years and older)

    Pharyngitis/tonsillitis

    250 mg b.i.d.

    10

    Acute bacterial maxillary sinusitis

    250 mg b.i.d.

    10

    Acute bacterial exacerbations of chronic bronchitis

    250 or 500 mg b.i.d.

    10a

    Secondary bacterial infections of acute bronchitis

    250 or 500 mg b.i.d.

    5-10

    Uncomplicated skin and skin-structure infections

    250 or 500 mg b.i.d.

    10

    Uncomplicated urinary tract infections

    250 mg b.i.d.

    7-10

    Uncomplicated gonorrhea

    1,000 mg once

    single dose

    Early Lyme disease

    500 mg b.i.d.

    20

    Pediatric Patients (who can swallow tablets whole)

    Acute otitis media

    250 mg b.i.d.

    10

    Acute bacterial maxillary sinusitis

    250 mg b.i.d.

    10

    a  The safety and effectiveness of Ceftin administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.

    Ceftin for Oral Suspension

    Ceftin for Oral Suspension may be administered to pediatric patients ranging in age from 3 months to 12 years, according to dosages in Table 8:

    Table 8. Ceftin for Oral Suspension

    (Must be administered with food. Shake well each time before using.)
    Population/Infection

    Dosage

    Daily Maximum Dose

    Duration (days)

    Pediatric Patients (3 months to 12 years)

    Pharyngitis/tonsillitis

    20 mg/kg/day divided b.i.d.

    500 mg

    10

    Acute otitis media

    30 mg/kg/day divided b.i.d.

    1,000 mg

    10

    Acute bacterial maxillary sinusitis

    30 mg/kg/day divided b.i.d.

    1,000 mg

    10

    Impetigo

    30 mg/kg/day divided b.i.d.

    1,000 mg

    10

    Patients With Renal Failure

    The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with renal failure.

    Directions for Mixing Ceftin for Oral Suspension

    Prepare a suspension at the time of dispensing as follows:

    1. Shake the bottle to loosen the powder.
    2. Remove the cap.
    3. Add the total amount of water for reconstitution (see Table 9) and replace the cap.
    4. Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder.
    5. Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.
    Table 9. Amount of Water Required for Reconstitution of Labeled Volumes of Ceftin for Oral Suspension
    Ceftin for Oral Suspension

    Labeled Volume After Reconstitution

    Amount of Water Required

    for Reconstitution

    125 mg/5 mL

    100 mL

    37 mL

    250 mg/5 mL

    50 mL

    19 mL

    100 mL

    35 mL

     

    NOTE: SHAKE THE ORAL SUSPENSION WELL BEFORE EACH USE. Replace cap securely after each opening. Store the reconstituted suspension between 2° and 8°C (36° and 46°F) (in a refrigerator). DISCARD AFTER 10 DAYS.

    How is Ceftin Supplied

    Ceftin Tablets

    Ceftin Tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX ES7″ on one side and blank on the other side as follows:

    20 Tablets/Bottle NDC 0173-0387-00

    Ceftin Tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX EG2″ on one side and blank on the other side as follows:

    20 Tablets/Bottle NDC 0173-0394-00

    Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.

    Ceftin for Oral Suspension

    Ceftin for Oral Suspension is provided as dry, white to off-white, tutti-frutti−flavored powder. When reconstituted as directed, Ceftin for Oral Suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. It is supplied in amber glass bottles as follows:

    125 mg/5 mL:

    100­mL Suspension NDC 0173-0740-00

    250 mg/5 mL:

    50-mL Suspension NDC 0173-0741-10

    100-mL Suspension NDC 0173-0741-00

    Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).

    After reconstitution, immediately store suspension between 2° and 8°C (36° and 46°F), in a refrigerator. DISCARD AFTER 10 DAYS.

    Clinical Studies

    Ceftin Tablets

    Acute Bacterial Maxillary Sinusitis One adequate and well-controlled study was performed in patients with acute bacterial maxillary sinusitis. In this study each patient had a maxillary sinus aspirate collected by sinus puncture before treatment was initiated for presumptive acute bacterial sinusitis. All patients had to have radiographic and clinical evidence of acute maxillary sinusitis. As shown in the following summary of the study, the general clinical effectiveness of Ceftin Tablets was comparable to an oral antimicrobial agent that contained a specific beta-lactamase inhibitor in treating acute maxillary sinusitis. However, sufficient microbiology data were obtained to demonstrate the effectiveness of Ceftin Tablets in treating acute bacterial maxillary sinusitis due only to Streptococcus pneumoniae or non−beta-lactamase−producing Haemophilus influenzae. An insufficient number of beta-lactamase−producing Haemophilus influenzae and Moraxella catarrhalis isolates were obtained in this trial to adequately evaluate the effectiveness of Ceftin Tablets in the treatment of acute bacterial maxillary sinusitis due to these 2 organisms.

    This study enrolled 317 adult patients, 132 patients in the United States and 185 patients in South America. Patients were randomized in a 1:1 ratio to cefuroxime axetil 250 mg twice daily or an oral antimicrobial agent that contained a specific beta-lactamase inhibitor. An intent-to-treat analysis of the submitted clinical data yielded the following results:

    Table 10. Clinical Effectiveness of Ceftin Tablets Compared to Beta-Lactamase Inhibitor-Containing Control Drug in the Treatment of Acute Bacterial Maxillary Sinusitis
    US Patientsa

    South American Patientsb

    Ceftin

    (n = 49)

    Control

    (n = 43)

    Ceftin

    (n = 87)

    Control

    (n = 89)

    Clinical success (cure + improvement)

    65%

    53%

    77%

    74%

    Clinical cure

    53%

    44%

    72%

    64%

    Clinical improvement

    12%

    9%

    5%

    10%

    a  95% Confidence interval around the success difference [-0.08, +0.32].

    b   95% Confidence interval around the success difference [-0.10, +0.16].

    In this trial and in a supporting maxillary puncture trial, 15 evaluable patients had non-beta-lactamase−producing Haemophilus influenzae as the identified pathogen. Ten (10) of these 15 patients (67%) had their pathogen (non-beta-lactamase−producing Haemophilus influenzae) eradicated. Eighteen (18) evaluable patients had Streptococcus pneumoniae as the identified pathogen. Fifteen (15) of these 18 patients (83%) had their pathogen (Streptococcus pneumoniae) eradicated.

    Safety

    The incidence of drug-related gastrointestinal adverse events was statistically significantly higher in the control arm (an oral antimicrobial agent that contained a specific beta-lactamase inhibitor) versus the cefuroxime axetil arm (12% versus 1%, respectively; P<.001), particularly drug-related diarrhea (8% versus 1%, respectively; = .001).

    Early Lyme Disease Two adequate and well-controlled studies were performed in patients with early Lyme disease. In these studies all patients had to present with physician-documented erythema migrans, with or without systemic manifestations of infection. Patients were randomized in a 1:1 ratio to a 20-day course of treatment with cefuroxime axetil 500 mg twice daily or doxycycline 100 mg 3 times daily. Patients were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).

    A total of 355 adult patients (181 treated with cefuroxime axetil and 174 treated with doxycycline) were enrolled in the 2 studies. In order to objectively validate the clinical diagnosis of early Lyme disease in these patients, 2 approaches were used: 1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion; and 2) serologic confirmation (using enzyme-linked immunosorbent assay [ELISA] and immunoblot assay [“Western” blot]) of the presence of antibodies specific to Borrelia burgdorferi , the etiologic agent of Lyme disease. By these procedures, it was possible to confirm the physician diagnosis of early Lyme disease in 281 (79%) of the 355 study patients. The efficacy data summarized below are specific to this “validated” patient subset, while the safety data summarized below reflect the entire patient population for the 2 studies.

    Analysis of the submitted clinical data for evaluable patients in the “validated” patient subset yielded the following results:

    Table 11. Clinical Effectiveness of Ceftin Tablets Compared to Doxycycline in the Treatment of Early Lyme Disease
    Part I

    (1 Month Posttreatment)a

    Part II

    (1 Year Posttreatment)b

    Ceftin

    Doxycycline

    Ceftin

    Doxycycline

    (n = 125)

    (n = 108)

    (n = 105c)

    (n = 83c)

    Satisfactory clinical outcomed

    91%

    93%

    84%

    87%

    Clinical cure/success

    72%

    73%

    73%

    73%

    Clinical improvement

    19%

    19%

    10%

    13%

    a  95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05).

    b 95% confidence interval around the satisfactory difference for Part II (-0.13, +0.07).

    c n’s  include patients assessed as unsatisfactory clinical outcomes (failure + recurrence) in Part I (Ceftin – 11 [5 failure, 6 recurrence]; doxycycline – 8 [6 failure, 2 recurrence]).

    d Satisfactory clinical outcome includes cure + improvement (Part I) and success + improvement (Part II).

    Ceftin and doxycycline were effective in prevention of the development of sequelae of late Lyme disease.

    Safety

    Drug-related adverse events affecting the skin were reported significantly more frequently by patients treated with doxycycline than by patients treated with cefuroxime axetil (12% versus 3%, respectively; = .002), primarily reflecting the statistically significantly higher incidence of drug-related photosensitivity reactions in the doxycycline arm versus the cefuroxime axetil arm (9% versus 0%, respectively; P<.001). While the incidence of drug-related gastrointestinal adverse events was similar in the 2 treatment groups (cefuroxime axetil – 13%; doxycycline – 11%), the incidence of drug-related diarrhea was statistically significantly higher in the cefuroxime axetil arm versus the doxycycline arm (11% versus 3%, respectively; = .005).

    Secondary Bacterial Infections of Acute Bronchitis Four randomized, controlled clinical studies were performed comparing 5 days versus 10 days of Ceftin for the treatment of patients with secondary bacterial infections of acute bronchitis. These studies enrolled a total of 1,253 patients (CAE-516 n = 360; CAE-517 n = 177; CAEA4001 n = 362; CAEA4002 n = 354). The protocols for CAE-516 and CAE-517 were identical and compared Ceftin 250 mg twice daily for 5 days, Ceftin 250 mg twice daily for 10 days, and AUGMENTIN® 500 mg 3 times daily for 10 days. These 2 studies were conducted simultaneously. CAEA4001 and CAEA4002 compared Ceftin 250 mg twice daily for 5 days, Ceftin 250 mg twice daily for 10 days, and CECLOR® 250 mg 3 times daily for 10 days. They were otherwise identical to CAE-516 and CAE-517 and were conducted over the following 2 years. Patients were required to have polymorphonuclear cells present on the Gram stain of their screening sputum specimen, but isolation of a bacterial pathogen from the sputum culture was not required for inclusion. The following table demonstrates the results of the clinical outcome analysis of the pooled studies CAE-516/CAE-517 and CAEA4001/CAEA4002, respectively:

    Table 12. Clinical Effectiveness of Ceftin Tablets 250 mg Twice Daily in Secondary Bacterial Infections of Acute Bronchitis: Comparison of 5 Versus 10 Days’ Treatment Duration
    CAE-516 and CAE-517a

    CAEA4001 and CAEA4002b

    5 Day

    (n = 127)

    10 Day

    (n = 139)

    5 Day

    (n = 173)

    10 Day

    (n = 192)

    Clinical success (cure + improvement)

    80%

    87%

    84%

    82%

    Clinical cure

    61%

    70%

    73%

    72%

    Clinical improvement

    19%

    17%

    11%

    10%

    a  95% Confidence interval around the success difference [-0.164, +0.029].

    b 95% Confidence interval around the success difference [-0.061, +0.103].

    The response rates for patients who were both clinically and bacteriologically evaluable were consistent with those reported for the clinically evaluable patients.

    Safety

    In these clinical trials, 399 patients were treated with Ceftin for 5 days and 402 patients with Ceftin for 10 days. No difference in the occurrence of adverse events was observed between the 2 regimens.

    REFERENCES

    1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 3rd ed. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. Villanova, Pa: NCCLS; 1993.
    2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. 4th ed. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7. Villanova, Pa: NCCLS; 1990.

    Ceftin and AUGMENTIN are registered trademarks of GlaxoSmithKline.

    CLINITEST and CLINISTIX are registered trademarks of Ames Division, Miles Laboratories, Inc.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    ©2010, GlaxoSmithKline

    All rights reserved.

    January 2010

    CFT:1PI

    Principal Display Panel

    NDC 0173-0387-00

    Ceftin® Tablets

    (cefuroxime axetil tablets)

    250 mg 20 Tablets

    Rx only

    See package insert for Dosage and Administration.

    Store between 15o and 30oC (59o and 86oF).

    Replace cap securely after each opening.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    Made in England

    4142817

    Rev. 2/02

    Principal Display Panel

    NDC 0173-0394-00

    Ceftin® Tablets

    (cefuroxime axetil tablets)

    500 mg

    Rx only

    20 Tablets

    Each tablet contains cefuroxime axetil equivalent to 500 mg of cefuroxime.

    See package insert for Dosage and Administration.

    Store between 15o and 30oC (59o and 86oF). Replace cap securely after each opening.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    Made in England

    4141667 Rev. 12/01

    Principal Display Panel

    NDC 0173-0740-00

    Ceftin® for Oral Suspension

    (cefuroxime axetil powder for oral suspension)

    For Oral Use Only

    125 mg per 5 mL

    100 mL (when reconstituted)

    Rx only

    Contains 3.0 g cefuroxime axetil equivalent to 2.5 g of cefuroxime.

    Phenylketonurics: Contains Phenylalanine 11.8 mg per 5 mL (1 teaspoonful) constituted suspension.

    See package insert for Dosage and Administration.

    Directions for Mixing Oral Suspension: Prepare the suspension at time of dispensing. Shake the bottle to loosen the powder. Remove the cap. Add 37 mL of water for reconstitution and replace the cap. Invert bottle and vigorously rock it from side to side so that water rises through the powder. Once the sound of powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.

    Before reconstitution, store dry powder between 2o and 30oC (36o and 86oF).

    After reconstitution, store suspension between 2o and 8oC (36o and 46oF), in a refrigerator. SHAKE WELL BEFORE EACH USE. Replace cap securely after each opening. Discard after 10 days.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    Made in England

    10000000022540 Rev. 12/05

    Principal Display Panel

    NDC 0173-0741-10

    Ceftin® for Oral Suspension

    (cefuroxime axetil powder for oral suspension)

    For Oral Use Only

    250 mg per 5 mL

    50 mL (when reconstituted)

    Contains 3.6 g cefuroxime axetil equivalent to 3 g of cefuroxime.

    Phenylketonurics: Contains Phenylalanine 25.2 mg per 5 mL (1 teaspoonful) constituted suspension.

    See package insert for Dosage and Administration.

    Directions for Mixing Oral Suspension: Prepare the suspension at time of dispensing. Shake the bottle to loosen the powder. Remove the cap. Add 19 mL of water for reconstitution and replace the cap. Invert bottle and vigorously rock it from side to side so that water rises through the powder. Once the sound of powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.

    Before reconstitution, store dry powder between 2o and 30oC (36o and 86oF).

    After reconstitution, store suspension between 2o and 8oC (36o and 46oF), in a refrigerator. SHAKE WELL BEFORE EACH USE. Replace cap securely after each opening. Discard after 10 days.

    GlaxoSmithKline

    Research Triangle Park, NC 27709

    Made in England

    10000000022489 Rev. 12/05

    Ceftin 

    cefuroxime axetil powder, for suspension

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0740
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME AXETIL 125 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ASPARTAME  
    POVIDONE K30  
    STEARIC ACID  
    SUCROSE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor TUTTI FRUTTI Imprint Code
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0173-0740-00 100 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA050672 06/02/2004
    Ceftin 

    cefuroxime axetil tablet, film coated

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0387
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME AXETIL 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL (capsule shaped) Size 15mm
    Flavor Imprint Code GX;ES7
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0173-0387-00 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA050605 10/01/1989
    Ceftin 

    cefuroxime axetil powder, for suspension

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0741
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME AXETIL 250 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ASPARTAME  
    POVIDONE K30  
    STEARIC ACID  
    SUCROSE  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor TUTTI FRUTTI Imprint Code
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0173-0741-00 100 mL in 1 BOTTLE, GLASS
    2 NDC:0173-0741-10 50 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA050672 06/02/2004
    Ceftin 

    cefuroxime axetil tablet, film coated

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0394
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CEFUROXIME AXETIL (CEFUROXIME) CEFUROXIME AXETIL 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL (capsule shaped) Size 20mm
    Flavor Imprint Code GX;EG2
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0173-0394-00 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA050605 10/01/1989
    Labeler - GlaxoSmithKline LLC (167380711)

    Revised: 07/2011   GlaxoSmithKline LLC

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    Ceftin

    Ceftin

    Pronunciation Generic Name: cefuroxime (SEF-ue-ROX-eem)

    Brand Name: Ceftin

    OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

    Ceftin is used for:

    Treating bacterial infections (sinus, skin, lung, urinary tract, ear, and throat). It may also be used to treat Lyme disease and gonorrhea.

    Ceftin is a cephalosporin antibiotic. It works by interfering with the formation of the bacteria’s cell wall so that the wall ruptures, resulting in the death of the bacteria.

    Do NOT use Ceftin if:

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

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

    Before using Ceftin:

    Tell your health care provider 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 diarrhea, a stomach or intestinal infection, or a blood clotting problem
    • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem)

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

    • Aminoglycosides (eg, gentamicin), cyclosporine, diuretics (eg, furosemide, hydrochlorothiazide), or other medicines affecting the kidney because side effects, such as kidney toxicity, may occur
    • Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Ceftin

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Ceftin 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 Ceftin:

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

    • Take Ceftin by mouth with or without food.
    • Swallow Ceftin whole. Do not break, crush, or chew before swallowing.
    • Ceftin works best if it is taken at the same time each day.
    • To clear up your infection completely, take Ceftin for the full course of treatment. Keep taking it even if you feel better in a few days.
    • If you miss a dose of Ceftin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose, and 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 Ceftin.

    Important safety information:

    • Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur during treatment or within several months after treatment with Ceftin. Do not treat diarrhea without first checking with your doctor.
    • The tablet and oral suspension forms of Ceftin are not equivalent. Do not substitute one for the other.
    • Ceftin only works against bacteria; it does not treat viral infections (eg, the common cold).
    • Be sure to use Ceftin 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 Ceftin 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.
    • Diabetes patients – Ceftin 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.
    • Hormonal birth control (eg, birth control pills) may not work as well while you are using Ceftin. To prevent pregnancy, use an extra form of birth control (eg, condoms).
    • Lab tests, including liver function, kidney function, and complete blood cell count, may be performed while you use Ceftin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
    • Ceftin should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ceftin while you are pregnant. Ceftin is found in breast milk. Do not breast-feed while taking Ceftin.

    Possible side effects of Ceftin:

    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:

    Diarrhea/loose stools; 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); bloody stools; change in the amount of urine; dark urine; easy bruising or bleeding; fatigue; fever; seizures; severe diarrhea; stomach cramps/pain; vaginal irritation or discharge; yellowing of the skin or eyes.

    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 Ceftin: Store Ceftin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ceftin out of the reach of children and away from pets.

    General information:

    • If you have any questions about Ceftin, please talk with your doctor, pharmacist, or other health care provider.
    • Ceftin 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 Ceftin 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 Ceftin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ceftin. 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 Ceftin.

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

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    Ceftin

    Ceftin

    Pronunciation Generic Name: cefuroxime (Oral route)

    sef-ue-ROX-eem AX-e-til

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Ceftin

    Available Dosage Forms:

    • Powder for Suspension
    • Tablet

    Therapeutic Class: Antibiotic

    Pharmacologic Class: 2nd Generation Cephalosporin

    Uses For Ceftin

    Cefuroxime is used to treat bacterial infections in many different parts of the body. It 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 Ceftin

    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 cefuroxime in children. However, safety and efficacy have not been established in infants younger than 3 months of age.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefuroxime in the elderly.

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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:

    • 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.
    • Phenylketonuria (PKU)—The oral liquid form of this medicine contains phenylalanine, which can make this condition worse.

    Proper Use of Ceftin

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Ceftin® oral liquid works differently than Ceftin® tablets, even at the same dose (number of milligrams). Do not switch from the tablets to the oral liquid unless your doctor tells you to.

    The oral liquid form must be taken with meals, while the tablet form may be given with or without food.

    Swallow the tablets whole. Do not break, crush, or chew it.

    Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

    Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For infections:
      • For oral dosage form (film-coated tablets):
        • Adults and teenagers—250 to 500 milligrams (mg) two times a day for 10 days. Gonorrhea is treated with a single 1-gram (g) dose.
        • Children (who can swallow the tablets)—250 mg two times a day for 10 days.
        • Children (who cannot swallow the tablets)—Use is not recommended.
      • For oral dosage form (suspension):
        • Children 3 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 30 milligrams (mg) per kilogram (kg) of body weight per day divided into two doses, taken for 10 days. However, the dose is usually not more than 1000 mg.
        • Infants up to 3 months—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Store the oral liquid in the refrigerator. Throw away any unused medicine after 10 days.

    Store the tablets in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Precautions While Using Ceftin

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

    Cefuroxime 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.

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

    Ceftin 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 immediately if any of the following side effects occur:

    More common

    • Chills
    • diarrhea
    • fever
    • general feeling of illness or discomfort
    • headache
    • itching of the vagina or genital area
    • pain during sexual intercourse
    • rigidity
    • sweating
    • thick, white vaginal discharge with no odor or with a mild odor

    Less common

    • Black, tarry stools
    • chest pain
    • cough
    • loose stools
    • painful or difficult urination
    • shortness of breath
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • swollen glands
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    Rare

    • Back, leg, or stomach pains
    • bladder pain
    • bleeding gums
    • bloody or cloudy urine
    • body aches or pain
    • burning while urinating
    • dark urine
    • difficulty with breathing
    • ear congestion
    • fast, pounding, or irregular heartbeat or pulse
    • frequent urge to urinate
    • general body swelling
    • loss of appetite
    • loss of voice
    • lower back or side pain
    • nasal congestion
    • nausea or vomiting
    • nosebleeds
    • pain or tenderness around the eyes and cheekbones
    • pale skin
    • pink or red urine
    • sneezing
    • stuffy or runny nose
    • swelling of the joints
    • swollen glands
    • tightness of chest or wheezing
    • white or brownish vaginal discharge
    • white patches in the mouth or throat or on the tongue
    • white patches with diaper rash
    • yellowing of the eyes or skin

    Incidence not known

    • Blistering, peeling, or loosening of the skin
    • bloody, black, or tarry stools
    • clay-colored stools
    • cough or hoarseness
    • coughing up blood
    • decrease in urine output or decrease in urine-concentrating ability
    • feeling of discomfort
    • fever with or without chills
    • general feeling of tiredness or weakness
    • high fever
    • hives
    • increased menstrual flow or vaginal bleeding
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • paralysis
    • prolonged bleeding from cuts
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red or black, tarry stools
    • red or dark brown urine
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • seizures
    • swollen lymph glands
    • swollen or painful glands
    • unpleasant breath odor
    • upper right abdominal or stomach pain
    • 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:

    Less common

    • Bad, unusual, or unpleasant (after) taste
    • change in taste
    • diaper rash

    Rare

    • Abdominal or stomach cramps
    • acid or sour stomach
    • belching
    • bloated
    • difficulty with moving
    • excess air or gas in the stomach or intestines
    • flushing or redness of the skin
    • full feeling
    • gas in the stomach
    • heartburn
    • indigestion
    • irritability
    • irritation or soreness of the mouth
    • itching skin
    • muscle pain or stiffness
    • muscle spasm of the neck
    • passing gas
    • restlessness
    • sleepiness or unusual drowsiness
    • stomach discomfort, upset, or pain
    • swelling of the tongue
    • thirst
    • trouble sitting still
    • unusually warm skin
    • watering of the mouth and drooling
    • weight loss

    Incidence not known

    • Hives or welts
    • redness of the skin

    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: Ceftin side effects (in more detail)

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    Ceftin

    Ceftin

    Pronunciation Generic Name: cefuroxime (SEF ue ROX eem)

    Brand Name: Ceftin

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is cefuroxime?

    Cefuroxime is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

    Cefuroxime is used to treat many kinds of bacterial infections, including severe or life-threatening forms.

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

    What is the most important information I should know about cefuroxime?

    Do not take this medication if you are allergic to cefuroxime, or to similar antibiotics, such as Cefzil, Keflex, Omnicef, and others.

    Before taking 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 history of intestinal problems, or if you are malnourished.

    Cefuroxime can make birth control pills less effective, which may result in pregnancy. Tell your doctor if you are taking birth control pills to prevent pregnancy. You may need to use another form of birth control during treatment with cefuroxime.

    Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefuroxime 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 you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefuroxime.

    What should I discuss with my health care provider before taking cefuroxime?

    Do not take this medication if you are allergic to cefuroxime, or to other cephalosporin antibiotics, such as:

    • cefaclor (Raniclor);

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

    Before taking cefuroxime, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

    • kidney disease;

    • liver disease;
    • a history of intestinal problems, such as colitis;
    • diabetes; or
    • if you are malnourished.

    If you have any of these conditions, you may need a dose adjustment or special tests to safely take cefuroxime.

    The oral suspension (liquid) form of cefuroxime may contain phenylalanine. Talk to your doctor before using this form of cefuroxime if you have phenylketonuria (PKU).

    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.

    Cefuroxime can make birth control pills less effective, which may result in pregnancy. Tell your doctor if you are taking birth control pills to prevent pregnancy. You may need to use another form of birth control during treatment with cefuroxime.

    Cefuroxime 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 take cefuroxime?

    Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

    You may take cefuroxime tablets with or without meals.

    Cefuroxime oral suspension (liquid) must be taken with food.

    Shake the oral liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

    If you switch from using the tablet form to using the oral suspension (liquid) form of cefuroxime, you may not need to use the same exact dosage in number of milligrams. The medication may not be as effective unless you use the exact form and strength your doctor has prescribed.

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

    This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefuroxime.

    Store cefuroxime tablets at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

    Store cefuroxime oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 10 days.

    What happens if I miss a dose?

    Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include seizure (black-out or convulsions).

    What should I avoid while taking cefuroxime?

    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.

    Cefuroxime 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 any of these serious side effects:

    • diarrhea that is watery or bloody;

    • fever, chills, body aches, flu symptoms;
    • chest pain, fast or pounding heartbeats;
    • unusual bleeding;
    • blood in your urine;
    • seizure (convulsions);
    • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
    • jaundice (yellowing of the skin or eyes);
    • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
    • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
    • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath; or
    • painful or difficult urination, urinating less than usual or not at all.

    Less serious side effects may include:

    • nausea, vomiting, stomach pain, mild diarrhea, gas, upset stomach;

    • cough, stuffy nose;
    • stiff or tight muscles, muscle pain;
    • joint pain or swelling;
    • headache, drowsiness;
    • feeling restless, irritable, or hyperactive;
    • white patches or sores inside your mouth or on your lips;
    • unusual or unpleasant taste in your mouth;
    • diaper rash in an infant taking liquid cefuroxime;
    • mild itching or skin rash; or
    • vaginal itching or discharge.

    This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Ceftin side effects (in more detail)

    What other drugs will affect cefuroxime?

    Before taking cefuroxime, tell your doctor if you are taking any of the following drugs:

    • probenecid (Benemid);

    • a blood thinner such as warfarin (Coumadin);
    • a medication that reduces stomach acid, such as an antacid, or cimetidine (Tagamet), famotidine (Pepcid), omeprazole (Prilosec), ranitidine (Zantac), and others; or
    • a diuretic (water pill) such as bumetanide (Bumex), furosemide (Lasix), indapamide (Lozol), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), torsemide (Demadex), and others.

    This list is not complete and there may be other drugs that can interact with cefuroxime. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

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    • Ceftin Consumer Overview
    • Ceftin Advanced Consumer (Micromedex) – Includes Dosage Information
    • Ceftin MedFacts Consumer Leaflet (Wolters Kluwer)
    • cefuroxime MedFacts Consumer Leaflet (Wolters Kluwer)
    • Cefuroxime Professional Patient Advice (Wolters Kluwer)
    • Cefuroxime Axetil Monograph (AHFS DI)
    • Zinacef Prescribing Information (FDA)
    • Zinacef Advanced Consumer (Micromedex) – Includes Dosage Information

    Compare Ceftin with other medications

    • Bacterial Infection
    • Bladder Infection
    • Bone infection
    • Bronchitis
    • Epiglottitis
    • Gonococcal Infection, Disseminated
    • Gonococcal Infection, Uncomplicated
    • Impetigo
    • Joint Infection
    • Kidney Infections
    • Lyme Disease
    • Meningitis
    • Otitis Media
    • Peritonitis
    • Pneumonia
    • Sepsis
    • Sinusitis
    • Skin and Structure Infection
    • Skin Infection
    • Strep Throat
    • Surgical Prophylaxis
    • Tonsillitis/Pharyngitis
    • Upper Respiratory Tract Infection
    • Urinary Tract Infection

    Where can I get more information?

    • Your pharmacist can provide more information about cefuroxime.

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