SILVADENE 10 mg/g
silver sulfadiazine · CREAM · A-S Medication Solutions
SILVADENE is a cream containing silver sulfadiazine at 10 mg/g, taken topical. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- SILVADENE
- Generic Name
- silver sulfadiazine
- NDC Code (Product)
50090-0230- Manufacturer
- A-S Medication Solutions
- 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 HistoryFull Prescribing Information
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 The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.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?
SILVADENE contains silver sulfadiazine. It is a cream taken topical. Consult your doctor for specific uses.
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 50090-0230, listed by A-S Medication Solutions.
Other Silver Brands
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- Silver Sulfadiazine10 mg/g80425-0221
- SSD Cream10 g/1000g43598-210
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)