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Silver Sulfadiazine

Silver Sulfadiazine

Pronunciation: SILL-ver SULL-fah-DIE-ah-zeen

Class: Burn preparation

For ProfessionalsSide EffectsInteractionsMore…

Trade Names

Silvadene

– Cream 10 mg/g in a water-miscible base

SSD

– Cream 10 mg/g in a water-miscible base

SSD AF

– Cream 10 mg/g in a water-miscible base

Thermazene

– Cream 10 mg/g in a water-miscible base

Flamazine (Canada)

Pharmacology

Inhibits bacteria by acting on cell membrane and cell wall.

Indications and Usage

Adjunct for prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Contraindications

Pregnancy in women approaching term; premature infants; infants during first 2 mo of life; hypersensitivity to any component of product.

Dosage and Administration

Adults Topical Clean and debride wound and apply cream under sterile conditions. Cover burn areas with cream at all times, applying 1 to 2 times daily to a thickness of about 1/ 16 inch. Reapply cream whenever necessary to any areas from which it has been removed by patient activity. Reapply immediately after hydrotherapy and continue until satisfactory healing has occurred or until burn site is ready for grafting.

Storage/Stability

Store cream at controlled room temperature (59° to 86°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

CNS reactions.

Dermatologic

Skin necrosis; erythema multiforme; skin discoloration; burning sensation; rashes; allergic reactions (including Stevens-Johnson syndrome, exfoliative dermatitis).

GI

GI reactions.

Genitourinary

Interstitial nephritis; toxic nephrosis.

Hepatic

Hepatitis; hepatocellular necrosis.

Hematologic-Lymphatic

Transient leukopenia characterized by decreased neutrophil count; blood dyscrasias (including agranulocytosis, aplastic anemia, thrombocytopenia, and hemolytic anemia).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Cross-sensitivity

Potential cross-sensitivity with other sulfonamides may occur.

Fungal proliferation

May occur in and below eschar.

Hepatic/Renal function impairment

Elimination of drug may become decreased, resulting in accumulation.

Patient Information

  • Advise patient or caregiver that cream is used to prevent infections in burn wounds in hospitalized and nonhospitalized patients.
  • Teach patient or caregiver using cream at home proper technique for applying cream: Wash hands. Using sterile gloves, apply sufficient cream ( 1/ 16 inch thickness) to cover affected areas. Wash hands after applying cream.
  • Advise patient or caregiver to apply cream twice daily as directed by health care provider.
  • Advise patient or caregiver to keep burned areas covered with cream at all times and to reapply cream whenever necessary to any area from which it has been removed by patient activity, bathing, or hydrotherapy.
  • Caution patient or caregiver not to bandage, cover, or wrap treated skin areas, or use other skin products over treated areas, unless advised by health care provider.
  • Caution patient to avoid contact with eyes. Advise patient that if medication does come into contact with the eyes to wash them with large amounts of cool water and to contact health care provider if eye irritation occurs.
  • Advise patient to report application-site reactions (eg, rash, burning, stinging, itching).

Copyright © 2009 Wolters Kluwer Health.

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Silver Sulfadiazine

Silver Sulfadiazine

Class: Local Anti-infectives, Miscellaneous

ATC Class: D06BA01

VA Class: DE500

CAS Number: 22199-08-2

Brands: Silvadene, SSD, Thermazene

For ProfessionalsSide EffectsDosageInteractionsMore…

Introduction

Sulfonamide; synthetic anti-infective agent.a b c e g h i j l

Uses for Silver Sulfadiazine

Prevention and Treatment of Burn Infections

Silver sulfadiazine cream is used topically as adjunct therapy to prevent and treat wound sepsis in second- and third-degree burns after resuscitative measures (e.g., control of shock and pain, correction of electrolyte imbalance) have been instituted.a b c e g h i j l

Control of bacterial growth may prevent conversion of deep, second-degree (partial-thickness) wounds to third-degree (full-thickness) wounds by sepsis.a b c i

Concomitant administration of appropriate systemic anti-infective agents may be necessary if infection present or suspected.c

Although controlled, comparative studies are lacking, silver sulfadiazine and mafenide are considered by many clinicians to be among the topical anti-infective agents of choice in burn patients.c g h i j

Mafenide appears to penetrate burn eschar better than silver sulfadiazine and may be more effective in minimizing the growth of bacteria and early treatment of wound sepsis.c j

Unlike mafenide, a carbonic anhydrase inhibitor, silver sulfadiazine does not alter acid-base balance and does not have a limited duration of therapy and area of topical application.a b c f

Softening action of silver sulfadiazine cream may aid in eschar removal and preparation of wound for grafting. c

Silver Sulfadiazine Dosage and Administration

General

  • Topically apply 1% silver sulfadiazine cream after appropriate regimens for burn care have been promptly instituted, including control of shock and pain.a b c l

Administration

Topical Administration

Cream

Apply 1% cream topically to cleansed, debrided burn wounds under sterile conditions (e.g., using a sterile-gloved hand).a b c

Topical cream should not be applied to the eye.a b

If possible, bathe patient daily to aid in debridement.c

Dressings usually not required but may be used.a b c

Dosage

Available as silver sulfadiazine; dosage expressed in terms of the salt.a b

Adults

Prevention and Treatment of Burn Infections
Topical

Apply 1% cream in a thickness of approximately 16 mm (1/16 inch) 1 or 2 times daily; cover burn area with cream at all times.a b c Reapply cream to any areas from which it has been removed by patient activity and reapply immediately following hydrotherapy.a b c

Continue applying cream as long as there is a possibility of infection unless a clinically important adverse reaction occurs.a b c Usually continue until healing is progressing well or site is ready for grafting.a b c

Special Populations

No special population dosage and administration recommendations at this time.a b c

Cautions for Silver Sulfadiazine

Contraindications

  • Pregnant women approaching or at term.a b c

  • Premature neonates or neonates ≤2 months of age.a b c
  • Known hypersensitivity to silver sulfadiazine or any ingredient in the formulation (e.g., methylparaben).a b c

Warnings/Precautions

Warnings

Systemic Absorption and Toxicity

When applied to extensive areas of the body and/or tissue damage is present, sulfadiazine may be absorbed systemically and produce adverse reactions characteristic of the sulfonamides, including hematologic effects (e.g., agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia), dermatologic and hypersensitivity reactions (e.g., Stevens-Johnson syndrome, exfoliative dermatitis), adverse GI effects, hepatitis and hepatocellular necrosis, adverse CNS effects, and toxic nephrosis.a b c d l m Skin discoloration (including argyria) also reported with topical application of silver sulfadiazine cream.a b c

Fungal Infections

Possible fungal proliferation in and below eschar; however, low reported incidence of fungal superinfection.a b c

Leukopenia

Transient leukopenia, principally manifested as decreased ANC, reported in an average of 20% of patients.a b c d e l m Maximal WBC count decrease occurs within the first 2–4 days after initiating therapy, and WBC count usually returns to normal within 2–3 days after onset of leukopenia regardless of whether silver sulfadiazine therapy is continued or discontinued.a b c d e m (See Specific Drugs under Interactions.)

Patients with G6PD Deficiency

Hemolysis may occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.a b c

Sensitivity Reactions

Sensitivity Reactions and Cross-sensitivity

Possible sensitivity reactions (e.g., blood dyscrasias, skin reactions [dermatitis, rashes, facial edema, pruritus], jaundice, hepatitis).a b c e g h k If allergic reaction occurs, consider discontinuance of drug.a b c

Possible cross-sensitivity with other sulfonamides and related compounds (e.g., sulfonylureas, carbonic anhydrase inhibitors, thiazides, loop diuretics).a b c (See Contraindications.)

General Precautions

Laboratory Testing and Propylene Glycol

In patients with extensive burns, monitor serum sulfonamide concentrations, carefully monitor renal function, and examine urine for sulfonamide crystals.a b c

Absorption of propylene glycol (contained in silver sulfadiazine cream) may affect serum osmolality, which may affect interpretation of some laboratory test results.a b c l

Delayed Wound Healing

Possible delay in wound healing; reduced bacterial growth may result in delayed eschar separation, which in some cases may require escharotomy.a b c h

Specific Populations

Pregnancy

Category B.a b

Because sulfonamides may cause kernicterus in neonates, silver sulfadiazine cream is contraindicated in pregnant women approaching or at term.a b c

Lactation

Not known whether topically applied silver sulfadiazine cream is distributed into milk.a b c However, because sulfonamides are distributed into milk and may cause kernicterus in premature neonates and neonates ≤2 months of age, discontinue nursing or the drug.a b c

Pediatric Use

The manufacturer states that safety and efficacy have not been established in pediatric patients;a b c however, silver sulfadiazine cream has been successfully used in some pediatric burn patients.e i

Because sulfonamide therapy has produced kernicterus in neonates, silver sulfadiazine cream is contraindicated in premature neonates or neonates ≤2 months of age.a b c (See Contraindications under Cautions.)

Hepatic Impairment

Possible sulfadiazine accumulation; consider discontinuance if therapeutic benefits to the patient do not outweigh possible risks.a b c

Renal Impairment

Possible sulfadiazine accumulation; consider discontinuance if therapeutic benefits to the patient do not outweigh possible risks.a b c (See Laboratory Testing and Propylene Glycol under Cautions.)

Common Adverse Effects

Local effects (pain, burning, itching, rash),a b c e k leukopenia.a b c d e m

Interactions for Silver Sulfadiazine

No formal drug interaction studies to date.a b c Since systemic sulfadiazine absorption may occur following topical application, consider possible drug interactions such as those reported with systemic administration of sulfonamides and related drugs.a b c

Specific Drugs

Drug

Interaction

Comments

Cimetidine

Increased incidence of leukopenia when used concomitantly with topical silver sulfadiazinea b m

Proteolytic enzymes, topical (e.g., collagenase, sutilains [no longer commercially available in the US])

Silver contained in silver sulfadiazine cream potentially may inactivate topical proteolytic enzymes used for debridementa b c

Silver Sulfadiazine Pharmacokinetics

Absorption

Bioavailability

Silver sulfadiazine itself does not appear to be absorbed following topical administration.a b c When in contact with body tissues and fluids, silver sulfadiazine slowly reacts with sodium chloride, sulfhydryl groups, and protein, resulting in sulfadiazine release.c Sulfadiazine may then be systemically absorbed from the site of application, particularly when silver sulfadiazine is applied to extensive areas and/or to damaged tissue.a b c e l

Plasma Concentrations

When applied to extensive burns, serum sulfadiazine concentrations of ≤12 mg/dL reported.a b c Patients treated with 5–10 g of silver sulfadiazine daily applied as a 1% cream had blood sulfadiazine concentrations of 1–2 mg/dL.c

Distribution

Extent

Not known whether topically applied silver sulfadiazine cream is distributed into milk; however, sulfonamides are distributed into milk.a b c

Elimination

Elimination Route

Systemically absorbed sulfadiazine excreted in urine.a b c e

Stability

Storage

Topical

Cream

15–30°C.a c

Actions and Spectrum

  • Mechanism of action of silver sulfadiazine appears to differ from sulfadiazine and silver nitrate; acts on cell membrane and cell wall to produce bactericidal effects.a b c g

  • Wide spectrum of activity against most burn pathogens, including species of both gram-positive and gram-negative organisms, including most species of Klebsiella, Proteus, Pseudomonas, and Staphylococcus.a b c Also inhibits Escherichia coli, Corynebacterium diphtheriae, and species of Acinetobacter, Citrobacter, Enterobacter, Providencia, Serratia, and streptococci.a b c Also has some activity against Candida albicans, Herpesvirus hominis, and Clostridium perfringens.a b c
  • Resistance reported occasionally.c

Advice to Patients

  • Importance of understanding that topical silver sulfadiazine preparations are intended for external use only.a b c

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.a b c
  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a b c
  • Importance of informing patients of other important precautionary information.a b c (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

Silver Sulfadiazine
Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

1%*

Silvadene (with methylparaben and propylene glycol)

Monarch

SSD (with cetyl alcohol, methylparaben, and propylene glycol)

Par

SSD AF (with methylparaben and propylene glycol)

Par

Thermazene (with propylene glycol)

Kendall

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 20/$27.99 or 60/$52.97

Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 50/$24.99 or 100/$40.97

Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 85/$38.99 or 255/$93.97

Silvadene 1% Cream (MONARCH PHARMACEUTICALS): 400/$73.99 or 1200/$198.96

Silver Sulfadiazine 1% Cream (WATSON LABS): 25/$13.99 or 50/$17.97

Silver Sulfadiazine 1% Cream (WATSON LABS): 85/$19.99 or 170/$29.97

Silver Sulfadiazine 1% Cream (WATSON LABS): 400/$32.99 or 1200/$95.97

SSD 1% Cream (DR.REDDY’S LABORATORIES): 400/$32.99 or 1200/$85.97

SSD 1% Cream (PAR): 50/$14.99 or 150/$25.97

Thermazene 1% Cream (SHERWOOD MEDICAL): 20/$13.99 or 40/$19.98

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 June 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Par Pharmaceutical, Inc. SSD (1% silver sulfadiazine) and SSD AF (1% silver sulfadiazine) cream prescribing information. Spring Valley, NY; 1999 May.

b. Monarch Pharmaceuticals, Inc. Silvadene cream 1% (silver sulfadiazine) prescribing information. Bristol, TN; 2003 Jul.

c. AHFS drug information 2008. McEvoy GK, ed. Silver Sulfadiazine. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3570-71.

d. Choban PS, Marshall WJ. Leukopenia secondary to silver sulfadiazine: frequency, characteristics and clinical consequences. Am Surg. 1987; 53:515-7. [PubMed 3631764]

e. Lockhart SP, Rushworth A, Azmy AAF et al. Topical silver sulphadiazine: side effects and urinary excretion. Burns. 1983; 10:9-12.

f. Liebman PR, Kennelly MM, Hirsch EF. Hypercarbia and acidosis associated with carbonic anhydrase inhibition: a hazard of topical mafenide acetate use in renal failure. Burns Incl Therm Inj. 1982; 8:95-8.

g. Castellano JJ, Shafii SM, Ko F et al. Comparative evaluation of silver-containing antimicrobial dressings and drugs. Int Wound J. 2007; 4:114-22. [PubMed 17651227]

h. Atiyeh BS, Costagliola M, Hayek SN et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007; 33:139-48. [PubMed 17137719]

i. Palmieri TL, Greenlaugh DG. Topical treatment of pediatric patients with burns: a practical guide. Am J Clin Dermatol. 2002; 3:529-34. [PubMed 12358554]

j. Monafo WW, West MA. Current treatment recommendations for topical burn therapy. Drugs. 1990; 40:364-73. [PubMed 2226220]

k. McKenna SR, Latenser BA, Jones LM et al. Serious silver sulphadiazine and mafenide acetate dermatitis. Burns. 1995; 21:310-2. [PubMed 7662136]

l. Kulick MI, Wong R, Okarma TB et al. Prospective study of side effects associated with the use of silver sulfadiazine in severely burned patients. Ann Plastic Surgery. 1985; 14:407-19.

m. Caffee HH, Bingham HG. Leukopenia and silver sulfadiazine. J Trauma. 1982; 22:586-7. [PubMed 7097818]

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Silver sulfadiazine

Silver sulfadiazine

Generic Name: silver sulfadiazine (SIL-ver sul-fa-DYE-a-zeen)

Brand Name: Examples include Silvadene and Thermazene

OverviewSide EffectsInteractionsFor ProfessionalsMore…

Silver sulfadiazine is used for:

Treating and preventing bacterial infection in second- and third-degree burns. It may also be used for other conditions as determined by your doctor.

Silver sulfadiazine is a sulfonamide. It kills bacteria by working on the cell membrane and cell wall.

Do NOT use silver sulfadiazine if:

  • you are allergic to any ingredient in silver sulfadiazine
  • you are pregnant and near your delivery date
  • you are taking methenamine

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

Before using silver sulfadiazine:

Some medical conditions may interact with silver sulfadiazine. 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 are allergic to sulfonamides (eg, sulfamethoxazole)
  • if you have kidney or liver problems or glucose-6-phosphate dehydrogenase deficiency

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

  • Methenamine because it may increase the risk of silver sulfadiazine’s side effects

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

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

  • Wash your hands thoroughly before and after application of silver sulfadiazine. Use a sterile-gloved hand to apply silver sulfadiazine to a thickness of approximately 1/16 inch on all affected areas. Whenever necessary, reapply the cream to keep the affected areas covered at all times.
  • To prevent or to clear up your infection completely, continue using silver sulfadiazine for the full course of treatment even if your condition improves in a few days. Do not miss any doses.
  • If you miss a dose of silver sulfadiazine, use 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 use 2 doses at once.

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

Important safety information:

  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Silver sulfadiazine is effective only against bacteria. It is not effective for treating viral infections.
  • It is important to use silver sulfadiazine for the full course of treatment. Failure to do so may decrease the effectiveness of silver sulfadiazine and increase the risk that the bacteria will no longer be sensitive to silver sulfadiazine and will not be able to be treated by this or certain other antibiotics in the future.
  • Long-term or repeated use of silver sulfadiazine may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
  • Silver sulfadiazine is not recommended for use in CHILDREN younger than 2 months old; safety and effectiveness in this age group 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 silver sulfadiazine while you are pregnant. It is not known if silver sulfadiazine is found in breast milk. Do not breast-feed while taking silver sulfadiazine.

Possible side effects of silver sulfadiazine:

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:

Burning; hives; itching; rash; redness; skin discoloration.

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); difficulty urinating.

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. Silver sulfadiazine may be harmful if swallowed.

Proper storage of silver sulfadiazine: Store silver sulfadiazine 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 silver sulfadiazine out of the reach of children and away from pets.

General information:

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

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

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