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

Logo ARGENT-EZE® CREAM

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ARGENT-EZE® CREAM

COMPOSITION:
Each gram contains 10 mg
Silver Sulphadiazine.
Preserved with:
  Propyl Hydroxybenzoate         0,05% m/v
  Methyl Hydroxybenzoate         0,05% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 14.2 Wound Dressing

PHARMACOLOGICAL ACTION:
Silver Sulphadiazine has antibacterial activity especially against Pseudomonas aeruginosa. As silver sulphadiazne 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. Sulphadiazine is now available to exert its bacteriostatic effect and is very slowly absorbed.
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+ + AgCl2-
Thus silver sulphadiazine acts as a sustained release depot of silver and sulphadiazine at the wound surface.
The 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 disturbances are minimised.

INDICATIONS:
Silver sulphadiazine is a topical antibacterial agent for the prevention of infection in severe
burns being particularly effective against Gram-negative organisms such asPseudomonas aeruginosa and pyocyanea, the most common cause of burn wound infection.

CONTRA-INDICATIONS:
Patents with a known sensitivity to Sulphonamides. Because of the possibility of kernicterus it should not be used by pregnant women near term or by new-born infants. Silver sulphadiazine should be used with care in the presence of hepatic or renal impairment, or when porphyria is suspected.

DOSAGE AND DIRECTIONS FOR USE:
FOR EXTERNAL USE ONLY
Silver sulphadiazne cream should be applied to a thickness of 3 to 5 mm daily with a sterile gloved hand and may, if desired, be covered by a thin gauze dressing. Treatment should be continued till the risk of infection has passed. One container should be reserved for one patient and any remaining cream should be discarded on completion of treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions have been reported, and patients should be watched carefully especially if there is a known reaction to sulphonamides. Separation of the eschar may be delayed. Local skin sensitivity may occur especially when exposed to sunlight. The safety of silver sulphadiazine in pregnancy has not been established. While little silver is absorbed, the plasma concentration of sulphadiazine may approach therapeutic levels, and particular attention must be paid to adequate fluid intake and acid-base balances.
A fall in white blood cell count has been demonstrated but it is not thought to be associated with the treatments used and probably reflects the condition of the burned patient.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:
A soft white cream.

PRESENTATION:
Packs of 50 g and 500 g.

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

REGISTRATION NUMBER:
Q/14.2/223.

APPLICANT:
Lennon Limited
7 Fairclough Road
Port Elizabeth 6001.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25/08/1983.

        M462

First presented on this site: September 1996
Current: September 2004
Source: Pharmaceutical Industry

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