SILVADENE (Page 2 of 2)

PRECAUTIONS

General

If hepatic and renal functions become impaired and elimination of drug decreases, accumulation may occur and discontinuation of SILVADENE Cream 1% (silver sulfadiazine) should be weighed against the therapeutic benefit being achieved.

In considering the use of topical proteolytic enzymes in conjunction with SILVADENE Cream 1%, the possibility should be noted that silver may inactivate such enzymes.

SILVADENE Cream 1% (silver sulfadiazine) is for topical use only. Avoid contact of SILVADENE Cream 1% (silver sulfadiazine) with the eye.

Laboratory Tests

In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfa concentrations. Renal function should be carefully monitored and the urine should be checked for sulfa crystals. Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

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 SILVADENE Cream 1% revealed no evidence of carcinogenicity.

Pregnancy

Teratogenic Effects.

A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in SILVADENE Cream 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 is excreted in human milk. However, sulfonamides are known to be excreted in human milk, and all sulfonamide 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 Silvadene Cream 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 pediatric patients 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 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.

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.

HOW SUPPLIED

SILVADENE Cream 1% (silver sulfadiazine) is available in jars containing 50 g (NDC 61570-131-50), 400 g (NDC 61570-131-40), and 1000 g (NDC 61570-131-98) and tubes containing 20 g (NDC 61570-131-20) , 25 g (NDC 61570-131-25), 50 g (NDC 61570-131-55) and 85 g (NDC 61570-131-85).

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

REFERENCES

  1. Caffee F, Bingham H. Leukopenia and silver sulfadiazine. J Trauma. 1982;22: 586–587.
  2. Jarret F, Ellerbe S, Demling R. Acute leukopenia during topical burn therapy with silver sulfadiazine. Amer J Surg. 1978;135:818–819.
  3. 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.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo

LAB-0647-6.0

September 2016

PRINCIPAL DISPLAY PANEL — 20 gram Tube Label

NDC 61570-131-20

SILVADENE ® CREAM 1%
(silver sulfadiazine)

20 grams

FOR TOPICAL USE ONLY.

Avoid contact with the eye.

DOSAGE AND USE

See accompanying prescribing
information.

KEEP OUT OF REACH OF CHILDREN

Store at Controlled Room Temperature 20° to 25° (68° to 77°F).

Pfizer Injectables

Rx only

Principal Display Panel -- 20 gram Tube Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 gram Tube Carton

SILVADENE ® CREAM 1%
(silver sulfadiazine)

NDC 61570-131-20

20 grams

Pfizer Injectables

Rx only

Principal Display Panel -- 20 gram Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 gram Jar Label

NDC 61570-131-50

SILVADENE® CREAM 1%
(silver sulfadiazine)
50 grams

FOR TOPICAL USE ONLY
Avoid contact with the eye.

GTIN: 00361570131502

Rx only

Pfizer Injectables

Principal Display Panel -- 50 gram Jar Label
(click image for full-size original)
SILVADENE
silver sulfadiazine cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-131
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-131-20 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (61570-131-20)
2 NDC:61570-131-85 1 TUBE in 1 CARTON contains a TUBE
2 85 g in 1 TUBE This package is contained within the CARTON (61570-131-85)
3 NDC:61570-131-50 50 g in 1 JAR None
4 NDC:61570-131-40 400 g in 1 JAR None
5 NDC:61570-131-98 1000 g in 1 JAR None
6 NDC:61570-131-25 1 TUBE in 1 CARTON contains a TUBE
6 25 g in 1 TUBE This package is contained within the CARTON (61570-131-25)
7 NDC:61570-131-55 1 TUBE in 1 CARTON contains a TUBE
7 50 g in 1 TUBE This package is contained within the CARTON (61570-131-55)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017381 11/26/1973
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (61570-131), MANUFACTURE (61570-131), PACK (61570-131)

Revised: 07/2021 Pfizer Laboratories Div Pfizer Inc

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