INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLAMAZINE* CREAM

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

FLAMAZINE* CREAM

COMPOSITION:
A white hydrophilic cream containing
silver sulphadiazine 0,01 g/gram of cream. Sterile if unopened.

PHARMACOLOGICAL CLASSIFICATION:
A 14.2 Wound dressing

PHARMACOLOGICAL ACTION:
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.

INDICATIONS:
FLAMAZINE is a topical antibacterial agent for the prevention and treatment of burn wound infections caused by Gram negative organisms such as Pseudomonas aeruginosa and Candida albicans.. FLAMAZINE can also be used for the treatment of leg ulcers and pressure sores

CONTRA-INDICATIONS:
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. FLAMAZINE should not be used if hepatic and renal function become impaired or if the condition of porphyria is suspected.

WARNINGS:
FOR EXTERNAL USE ONLY.
The safety of FLAMAZINE 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:
FLAMAZINE 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 FLAMAZINE 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 FLAMAZINE 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.

IDENTIFICATION:
A white to off-white cream.

PRESENTATION:
FLAMAZINE is available in 500 g and 250 g jars and in tubes of 50 g.

STORAGE INSTRUCTIONS:
Store below 25°C protected from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
H/14.2/3003

NAME AND BUSINESS ADDRESS OF APPLICANT:
Smith & Nephew Pharmaceuticals (Pty) Limited,
30 Gillitts Road, Pinetown 3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 2000

* Trademark of Smith & Nephew.

        1840 0517

Updated on this site: April 2005
Source: Hospital Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005