Silver Sulfadiazene label

Silver Sulfadiazene

Silver Sulfadiazene Recall

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Side Effects & Adverse Reactions

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 in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Silver Sulfadiazine Cream 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.

History

There is currently no drug history available for this drug.

Other Information

Silver Sulfadiazine Cream is a topical antibacterial preparation which has its active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base.

Each 1000 grams of Silver Sulfadiazine Cream contains 10 grams of silver sulfadiazine.

Inactive Ingrediants: cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative.

Silver sulfadiazine has an emprical formula of C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown:

structural formula of silver sulfadiazine

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Silver Sulfadiazene Recall

Side Effects & Adverse Reactions

FDA Safety Alerts

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Silver Sulfadiazene Manufacturers

Watson Laboratories, Inc.
No Recall
Silver Sulfadiazene | Watson Laboratories, Inc.
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.
Rebel Distributors Corp
No Recall
Silver Sulfadiazene | Rebel Distributors Corp
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.
Unit Dose Services
No Recall
Silver Sulfadiazene | Unit Dose Services
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. FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE:

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.
Unit Dose Services
No Recall
Silver Sulfadiazene | Unit Dose Services
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. FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE:

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.
Remedyrepack Inc.
No Recall
Silver Sulfadiazene | Remedyrepack Inc.

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.