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Flammazine

Flammazine

silver sulfadiazine

Manufacturer:

A. Menarini

Distributor:

Zuellig
Full Prescribing Info
Contents
Silver sulfadiazine (micronized).
Description
Flammazine is a hydrophilic cream containing micronized silver sulfadiazine 10 mg/g.
Quantitative composition per 100 g of cream: Silver sulfadiazine 1 g, polysorbate 60 1 g, polysorbate 80 1 g, glyceryl monostearate 4 g, cetyl alcohol 4 g, propylene glycol 7 g, liquid paraffin 20 g, purified water 62 g.
Action
Topical antibacterial.
Pharmacology: Clinical investigations have shown that Flammazine, because of its bacteriostatic and bactericidal activity, is a very effective therapy in the treatment of local infections caused by both gram-positive especially gram-negative microorganisms eg, Pseudomonas, Klebsiella and Enterobacter.
Indications/Uses
Treatment and prevention of infected burn wounds. Treatment of infected skin lesions.
Dosage/Direction for Use
Flammazine cream can be applied directly to the wound in a layer of at least 2-3 mm thick. Flammazine can also be applied using a sterile gauze dressing. The cream should be re-applied at least every 24 hrs after removal of the old layer of cream. Application is easy and painless. Discoloration of bed linen and clothes does not occur.
Contraindications
Sensitization by Flammazine has not been reported in clinical studies. Only in theoretical grounds should attention be paid to the following possible contraindications of sulfonamides: Hypersensitivity, liver damage and oliguria.
Special Precautions
Upon exposure to sunlight, a grayish discoloration of the cream may occur. It is therefore advised not to expose Flammazine treated body parts to direct sunlight.
Use In Pregnancy & Lactation
Use in pregnancy: Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetuses. Nevertheless, the potential benefit of treating pregnant women with Flammazine cream should be weighed against the possible risks to the mother and baby.
Side Effects
Leukopenia has been reported in a restricted number of patients (0.4% incidence). In most of these patients, the white blood cell (WBC) count returned to normal in spite of prolonged treatment. In case signs or symptoms possibly related to leukopenia appear or when the patient is known to be hypersensitive to sulfonamides, a WBC count is recommended.
Skin rash has been reported in a small number of patients (0.3% incidence), but appears to be related to excipients propylene glycol and cetyl alcohol. Silver sulfadiazine has not been shown to alter electrolyte balance.
Storage
Store at temperatures not exceeding 25°C.
MIMS Class
Topical Antibiotics
ATC Classification
D06BA01 - silver sulfadiazine ; Belongs to the class of topical sulfonamides used in the treatment of dermatological diseases.
Presentation/Packing
Form
Flammazine cream 1%
Packing/Price
20 g x 1's (P876.25/tube);5 g x 24 × 1's (P334.25/tube);50 g x 1's
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