SILVADENE 10 mg/g

silver sulfadiazine · CREAM · Pfizer Laboratories Div Pfizer Inc

No Recall History

Plain English

Silvadene is a prescription antibiotic cream containing silver sulfadiazine that is applied directly to the skin to prevent and treat bacterial infections in burn wounds. It works by killing bacteria and is commonly used in burn care to reduce infection risk.

Key Facts

Brand Name: SILVADENE
Generic Name: silver sulfadiazine
NDC Code (Product): 61570-131
Manufacturer: Pfizer Laboratories Div Pfizer Inc
Strength: 10 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: NDA017381
Drug Class: Sulfonamide Antibacterial [EPC]
Marketing Start: 11/26/1973

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pain152 reports

off label use151 reports

fatigue148 reports

product use in unapproved indication141 reports

nausea135 reports

death120 reports

diarrhoea117 reports

drug ineffective111 reports

chronic kidney disease107 reports

dyspnoea103 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Dosage & Administration

DOSAGE AND ADMINISTRATION Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided, and SILVADENE Cream 1% (silver sulfadiazine) is applied under sterile conditions. The burn areas should be covered with SILVADENE Cream 1% at all times. The cream should be applied once to twice daily to a thickness of approximately 1/16 inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed by patient activity. Administration may be accomplished in minimal time because dressings are not required. However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with SILVADENE Cream 1% should be continued until satisfactory healing has occurred, or until the burn site is ready for grafting. The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Warnings

WARNINGS Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Some of the reactions, which have been associated with sulfonamides, are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions; hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis. There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur. However, the incidence of clinically reported fungal superinfection is low. The use of SILVADENE Cream 1% (silver sulfadiazine) in some cas…

Contraindications

CONTRAINDICATIONS SILVADENE Cream 1% (silver sulfadiazine) is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. Because sulfonamide therapy is known to increase the possibility of kernicterus, SILVADENE Cream 1% should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

Adverse Reactions

ADVERSE REACTIONS Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. 1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine. Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Frequently Asked Questions

What is SILVADENE used for?

Is SILVADENE a controlled substance?

SILVADENE is not classified as a controlled substance by the DEA.

What is the generic name for SILVADENE?

The generic name for SILVADENE is silver sulfadiazine. There are 12 other brand versions of silver sulfadiazine.

What is the NDC code for SILVADENE 10 mg/g?

The NDC (National Drug Code) for SILVADENE 10 mg/g is 61570-131, listed by Pfizer Laboratories Div Pfizer Inc.

Product NDC

61570-131

Package NDC

61570-131-20

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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