Silver Sulfadiazine (Page 2 of 2)

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).

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.

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.

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

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 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. An increased 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.

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.

REFERENCES

Caffee F, Bingham H. Leukopenia and silver sulfadiazine. J Trauma. 1982;22: 586–587.
Jarret F, Ellerbe S, Demling R. Acute leukopenia during topical burn therapy with silver sulfadiazine. Amer J Surg. 1978;135:818–819.
Kiker RG, Carvajal HF, Micak RP, Larson DL. A controlled study of the effects of silver sulfadiazine on white blood cell counts in burned children. J Trauma. 1977; 17:835–836.

HOW SUPPLIED

Silver sulfadiazine cream, USP 1% — white to off-white cream

NDC Number Size

63187-023-25 25g tube

Store at room temperature. 15°-30°C (56°-86°F).

Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645
Manufactured by:
Crown Laboratories, Inc.
Johnson City, TN 37604

Repackaged by:
Proficient Rx LPThousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL — 50g

63187-023-50
(click image for full-size original)
SILVER SULFADIAZINE silver sulfadiazine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-023(NDC:67877-124)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILVER SULFADIAZINE (SULFADIAZINE) SILVER SULFADIAZINE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Stearyl Alcohol
Petrolatum
Polyoxyl 40 Stearate
Propylene Glycol
Isopropyl Myristate
Sorbitan Monooleate
Methylparaben 3 mg in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-023-50 50 g in 1 TUBE None
2 NDC:63187-023-25 25 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018810 12/23/1985
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-023), RELABEL (63187-023)

Revised: 01/2020 Proficient Rx LP

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