(and dosage form):
A white hydrophilic cream containing silver sulphadiazine 0,01 g/gram of cream.
A 14.2 Wound dressing
As silver sulphadiazine is relatively insoluble, it reacts very slowly with the chloride and protein components of tissue exudate to form silver chloride, silver protein complexes and sodium sulphadiazine. The mechanisms for silver ion release are complex, but silver chloride is very slightly soluble and slowly releases silver ions, which are then free to exert their bactericidal effect. These silver ions are thought to be reversibly adsorbed by bacterial cells by association with SH groups or histidine residues in the bacterial protein of the transport system across the cell wall.
NaCl + AgSd > AgCl + NaSd
AgCl ========= Ag+ + Cl¯
AgCl + NaCl ========= Na+ + AgCl¯2
Thus silver sulphadiazine acts as a sustained release depot of silver and sulphadiazine at the wound surface. This slow liberation of silver does not cause the rapid and extensive depletion of chloride ion experienced when silver nitrate solutions are used and thus electrolyte disturbance is minimised.
BACTRAZINE is a topical antibacterial agent for the treatment of infected leg ulcers, pressure sores and burns, caused by Gram negative organisms such as Pseudomonas aeruginosa and Pyocyanea. Bactrazine has also been shown to be effective against Candida albicans and to exert a therapeutic effect in burns which are already infected.
Hypersensitivity to sulphonamide. Because sulphonamide therapy is known to increase the possibility of kernicterus, silver sulphadiazine cream should not be used in pregnant women at term, in premature infants or in infants during the first months of life. BACTRAZINE should not be used if hepatic and renal function become impaired or if the condition of porphyria is suspected.
FOR EXTERNAL USE ONLY.
The safety of BACTRAZINE in pregnancy and lactation has not been established. A fall in white blood cell count has been demonstrated, but is not thought to be associated with the treatment used and probably reflects the condition of the burned patient.
DOSAGE AND DIRECTIONS FOR USE:
BACTRAZINE should be applied daily in a layer approximately 3-5 mm thick with a sterile gloved hand or spatula. The wound may be dressed or left open. One container of BACTRAZINE should be reserved for one patient and any remaining cream should be discarded on completion of treatment.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Patients should be watched carefully for sensitivity reactions; the separation of the eschar may be delayed and fungal invasion of the wound may occur. Local skin sensitivity to BACTRAZINE may occur, especially when exposed to sunlight. Appreciable amounts of sulphadiazine may be absorbed systemically to produce therapeutic blood levels, and particular attention must be paid to adequate fluid intake and acid base balances.
A white to off-white cream.
BACTRAZINE is available in 500 g and 250 g jars and in tubes of 50 mL.
Store below 25°C protected from light.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 27, 1991
9/115 SNP 39/02
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