Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: Smith & Nephew Ltd, Unit A, 36 Hillside Road, Wairau Valley, Auckland 0627, New Zealand
As sulfonamides are known to cause kernicterus, 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 any of the excipients listed in section 6.1.
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.
Patients should be watched carefully for sensitivity, especially if there are known reactions to sulfonamides.
Local reactions have been reported in patients treated with silver sulfadiazine; the separation of the eschar may be delayed and fungal invasion of the wound may occur.
In patients with extensive burns, serum sulfonamide concentrations and renal function should be monitored and urine examined for sulfonamide crystals. Absorption of propylene glycol contained in the cream can affect serum osmolality which can interfere with some laboratory tests.
The use of FLAMAZINE cream in some cases of glucose-6-phosphate dehydrogenase-deficient patients may be hazardous as haemolysis may occur.
During treatment of burns over a large body area, significant amounts of silver sulfadiazine are systemically absorbed. Therefore, it is possible that any adverse reactions associated with sulfonamides may occur.
FLAMAZINE 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.
Of the total number of subjects in clinical studies of Silver sulfadiazine cream, 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.
In the treatment of burn wounds involving extensive areas of the body, the serum sulfonamide derivative concentrations may approach adult therapeutic levels (8 mg% to 12 mg%). Therefore, in these patients it would be advisable to monitor serum sulfonamide concentrations. Renal function should be carefully monitored and the urine should be checked for sulfonamide crystals. Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.
As silver may inactivate enzymatic debriding agents, their concomitant use may be inappropriate.
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.
Cimetidine: in patients with large area burns, it has been reported that co-administration of cimetidine may increase the incidence of leukopenia.
Sulfonamide may alter the effect of oral anticoagulants, methotrexate, and cyclosporine. There are isolated reports that sulfonamide may also interfere with the effectiveness of hormonal contraceptive.
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.
FLAMAZINE 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.
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.
Common: Leukopenia
Leukopenia has been reported in 3-5% of burns patients treated with FLAMAZINE. 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 FLAMAZINE 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.
Common: Application site burning
Very rare: Renal failure
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.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/
None known.
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