Silver sulfadiazine

Silver sulfadiazine should be use with caution in patients with impaired renal or hepatic function. Sensitivity has been shown to occur but the incidence is lower than with other sulfonamides.

In large-area burns where serum sulfadiazine levels may approach therapeutic levels, it should be noted that the effects of systemically administered drugs may be altered. This can especially apply to oral hypoglycaemic agents and to phenytoin. In the case of these drugs, it is recommended that blood levels should be monitored as their effects can be potentiated.

Sulfonamide may alter the effect of oral anticoagulants, methotrexate, and cyclosporine.

As silver may inactivate enzymatic debriding agents, their concomitant use may be inappropriate.

In patients with large area burns, it has been reported that co-administration of cimetidine may increase the incidence of leukopenia.

The use of silver-sulfadiazine in some cases of glucose-6-phosphate dehydrogenase-deficient patients may be hazardous as haemolysis may occur.

Pregnancy Category C.

Sulfonamides may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Sulfonamides should therefore be avoided as far as possible during the last month of pregnancy.

Silver sulfadiazine should be used with caution in breast-feeding mothers. Systemically, sulfadiazine can be excreted in breast milk although at concentrations 15-35% of those found in serum.

Effects on Fertility

No data were available from studies in animals following topical administration of silver sulfadiazine. No treatment-related effects on male or female fertility were documented following subcutaneous administration of silver sulfadiazine to rats at doses up to 500mg/kg/day for two (females) or ten (males) weeks prior to mating.

The effects of this medicine on a person’s ability to drive and use machines were not assessed.

Blood & lymphatic Tissue Disorders

Common: Leukopenia

Leukopenia has been reported in 3-5% of burns patients treated with silver sulfadiazine. This may be a drug related effect, and often manifests itself 2-3 days after treatment has commenced. It is usually self-limiting and therapy with silver sulfadiazine cream does not usually need to be discontinued, although the blood count must be monitored to ensure that it returns to normal within a few days.

General Disorders & Administration Site Conditions

Common: Application site burning

Renal & Urinary Disorders

Very rare: Renal failure

Skin & Subcutaneous Tissue Disorders

Common: Pruritis

Common: Application site rash (including eczema and contact dermatitis)

Rare: Argyria

There is evidence that in large area wounds and/or after prolonged application, systemic absorption of silver can occur causing clinical argyria.