Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM FUSIDATE
HOVID BERHAD
SODIUM FUSIDATE
15gm mcg/mL
HOVID BERHAD
DESCRIPTION Light yellow ointment. COMPOSITION Sodium fusidate (micronised) 2.0% w/w PHARMACODYNAMICS Fusidic acid is a steroidal antibiotic with a bacteriostatic or bactericidal activity, mainly against Gram positive bacteria. Fusidic acid inhibits bacterial protein synthesis although, in contrast to drugs such as the macrolides or tetracyclines, it does not bind to the bacterial ribosomes, but inhibits a factor necessary for translocation of peptide subunits and elongation of the peptide chain. PHARMACOKINETICS _In vitro_ studies showed that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. INDICATIONS DISUF OINTMENT is indicated for the treatment of skin infections caused by _staphylococci, _ _streptococci, _ _corynebacterium minutissimum_ and other organisms sensitive to fusidic acid. The most important indications being: Impetigo, Boils, Carbuncles, Paronychia, Infected wounds, Sycosis barbae, Hidradenitis, Erythrasma, Folliculitis. CONTRAINDICATIONS Infections caused by non-susceptible organisms. Patients with hypersensitivity to any of the ingredients. WARNINGS AND PRECAUTIONS The sodium salt of fusidic acid has been shown to cause conjunctival irritation.The ointment should not be used in or near the eyes. Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of contact sensitization and the development of antibiotic resistance. PREGNANCY AND LACTATION There is inadequate evidence of safety in human pregnancy. Safety in nursing mothers has not been established. MAIN SIDE / ADVERSE EFFECTS Hypersensitivity reactions in the form of rashes and irritation may occur after the topical administration of fusidates. OVERDOSE Not applicable. DOSAGE AND ADMINISTRATION For Topical Use Apply 2 Baca dokumen lengkap