FLAMAZINE

What it is

FLAMAZINE is a cream containing silver sulfadiazine 1.0% w/w. It is a white to off-white cream presented as a semi-solid oil in water emulsion.

Approved indications

— Prevention of infection in severe burns. — Pressure sores. — Leg ulcers.

Dosing overview

For burns, the burn wound should be cleaned and FLAMAZINE cream applied over all the affected areas to a depth of 3–5 mm. FLAMAZINE cream should be re-applied at least every 24 hours, or more frequently if the volume of exudate is large. For leg ulcers and pressure sores, the cavity of the ulcer should be filled with FLAMAZINE cream to a depth of at least 3–5 mm. The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48 hours) may be acceptable. For finger-tip injuries, a 3–5 mm layer of FLAMAZINE cream should be applied after haemostasis of the injury has been achieved. Dressings should be changed every 2–3 days.

Key safety warnings

Life-threatening cutaneous reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of sulfadiazine. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence is within the first weeks of treatment. Transient leucopenia has occurred although its association with application of FLAMAZINE has not been confirmed. Nevertheless, regular blood counts are advisable in patients on long-term treatment. In patients with extensive burns, serum sulfonamide concentrations and renal function should be monitored and urine examined for sulfonamide crystals. The use of FLAMAZINE cream in some cases of glucose-6-phosphate dehydrogenase-deficient patients may be hazardous as haemolysis may occur.

Contraindications

FLAMAZINE cream should not be used at, or near term pregnancy, on premature infants or on newborn infants during the first months of life. FLAMAZINE cream is also contraindicated in patients known to be hypersensitive to silver sulfadiazine or to other components of the preparation such as cetyl alcohol or propylene glycol.

Regulatory history

FLAMAZINE silver sulfadiazine 1.0% w/w cream was first listed on the Australian Register of Therapeutic Goods on 11 June 2010. The most recent revision was on 18 April 2024, which included updates to safety warnings regarding Stevens-Johnson syndrome and toxic epidermal necrolysis.