Silver Sulfadiazene (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term dermal toxicity studies of 24 months duration in rats and 18 months in mice with concentrations of silver sulfadiazine three to ten times the concentration in Silver Sulfadiazine Cream revealed no evidence of carcinogenicity.

Pregnancy

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 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).

Nursing Mothers

It is not known whether Silver Sulfadiazine Cream 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 potential 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.

Pediatric Use

Safety and effectiveness in children have not been established (See CONTRAINDICATIONS).

ADVERSE REACTIONS

Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy. Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within two to four days of initiation of therapy. Rebound to normal leukocyte levels follows onset within two to three days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leucopenia in various reports averages about 20%. A higher incidence has been seen 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.

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, leucopenia, hemolytic anemia; dermatologic and allergic reactions, Stevens-Johnson syndrome and exfoliative dermatitis; gastrointestinal reactions; hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

DOSAGE AND ADMINISTRATION

FOR TOPICAL USE ONLY — NOT FOR OPHTHALMIC USE: 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 Silver Sulfadiazine Cream is applied under sterile conditions. The burn areas should be covered with Silver Sulfadiazine Cream 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 due to 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 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.

HOW SUPPLIED

Silver Sulfadiazine Cream USP 1%: white to off-white cream.

25 gram tube

Store at controlled room temperature 15°-30°C (59°-86°F).
Manufactured for
Watson Laboratories, Inc.
Corona, CA 92880 USA
Manufactured by
Dr. Reddy’s Laboratories Louisiana, LLC
Shreveport, LA 71106
R05/08 110960-02

Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Silver Sulfadiazine 1%
(click image for full-size original)

SILVER SULFADIAZENE
silver sulfadiazine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-118(NDC:0591-0810)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILVER SULFADIAZINE (SILVER SULFADIAZINE) SILVER SULFADIAZINE 10 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
STEARYL ALCOHOL
PETROLATUM
POLYOXYL 40 STEARATE
PROPYLENE GLYCOL
ISOPROPYL MYRISTATE
SORBITAN MONOOLEATE
METHYLPARABEN
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-118-25 25 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018578 02/25/1982
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2012 Rebel Distributors Corp

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