silver sulfADIAZINE 1 % Topical Cream

Details

Generic Name: SILVER SULFADIAZINE

Brand Name: Silver Sulfadiazine

Substance Name(s):
SILVER SULFADIAZINE

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 a 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 silver sulfadiazine cream, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

DESCRIPTION

Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application.

Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine.

This active agent has the following structural formula: Silver sulfadiazine cream contains 1% w/w silver sulfadiazine.

The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative.

Structural Formula

HOW SUPPLIED

Product: 50090-0717 NDC: 50090-0717-0 50 g in a TUBE

GERIATRIC USE

Geriatric Use.

Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 1% seven percent were 65 years of age and over.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

INDICATIONS AND USAGE

Silver sulfadiazine cream, USP 1% 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.

PEDIATRIC USE

Pediatric Use.

Safety and effectiveness in children have not been established.

(See CONTRAINDICATIONS )

PREGNANCY

: TERATOGENIC EFFECTS: Pregnancy Category B.

A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in silver sulfadiazine cream, USP 1% and has revealed no evidence of harm to the fetus due to silver sulfadiazine.

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 justified, especially in pregnant women approaching or at term.

(See CONTRAINDICATIONS )

NUSRING MOTHERS

Nursing Mothers.

It is not known whether silver sulfadiazine cream, USP 1% is excreted in human milk.

However, sulfonamides are known to be excreted in human milk and all sulfonamides derivatives are known to increase the possibility of kernicterus.

Because of the possibility for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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; silver sulfadiazine cream, USP 1% is then applied under sterile conditions.

The burn areas should be covered with silver sulfadiazine cream, USP 1% at all times.

The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an 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 silver sulfadiazine cream, USP 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.