Fusidane

Fusidane

fusidic acid

Manufacturer:

Dongkwang Pharm

Distributor:

Endure Medical
Full Prescribing Info
Contents
Sodium fusidate.
Description
Each gram contains: Fusidate (as sodium) 20 mg.
Action
Pharmacology: Fusidate is a steroidal antibacterial with bacteriostatic or bactericidal activity, mainly against Gram positive bacteria. Fusidate inhibits bacterial protein synthesis although, in contrast to drugs such as the macrolides or tetracyclines, it does not bind to the bacterial ribosome, but inhibits a factor necessary for translocation of peptide subunits and elongation of the peptide chain. It is capable of inhibiting protein synthesis in mammalian cells but exerts a selective action against susceptible infecting organisms because of poor penetration into the host cell. Fusidate is very active against staphylococci, notably Staph. aureus and Staph. epidermidis (including methicillin-resistant strains). Nocardia asteroides and many clostridial strains are also highly susceptible. The streptococci and enterococci are less susceptible. Most Gram-negative bacteria are intrinsically resistant but Fusidate is active against Neisseria spp. and Bacteroides fragilis. It has some activity against strains of Mycobacterium tuberculosis and is highly active against M. leprae. Fungi are resistant, but Sodium fusidate has some activity against a range of protozoa including Giardia lamblia and Plasmodium falciparum. High concentrations of fusidate are reported to inhibit viral growth in vitro, including that of HIV, although it is unclear whether this represents a surfactant effect, a general cytotoxic effect, or a genuine antiviral action.
Pharmacokinetics: Fusidate is well absorbed from the gastrointestinal tract, and a single oral 500-mg dose is reported to produce mean plasma concentrations of about 30 micrograms/mL within 2 to 4 hours, although there is considerable interindividual variation. Oral suspensions of fusidic acid are less well absorbed, with a bioavailability reported to be about 70% of that for fusidate. Absorption may be delayed by food and may be more rapid in children than adults. Some accumulation occurs with repeated dosage and plasma concentrations of 100 micrograms/mL or more have been reported after 500 mg of sodium fusidate given three times daily for 4 days. Fusidate is widely distributed into tissues and body fluids, including bone, pus, and synovial fluid; it penetrates cerebral abscesses but does not enter cerebrospinal fluid in appreciable amounts. It has been found in the fetal circulation and in breast milk. About 95% or more of fusidate in the circulation is bound to plasma proteins. Fusidate has a plasma half-life of about 10 to 15 hours. It is excreted in the bile, almost entirely as metabolites, some of which have weak antimicrobial activity. About 2% appears unchanged in the feces. Little is excreted in the urine or removed by haemodialysis.
Indications/Uses
Used in the treatment of staphylococcal skin infections; 1st line therapy for topical treatment of skin impetigo.
Dosage/Direction for Use
Apply to the affected area two (2) to three (3) times a day for seven (7) days or as prescribed by the physician.
Contraindications
Contraindicated in patients with hypersensitivity to the drug or any of its components.
Special Precautions
Resistance may occur. Caution has been advised if it is given to premature, jaundiced, acidotic, or seriously-ill neonates because of the risk of kernicterus. Caution is also required in the following: biliary disease or biliary obstruction and hepatic impairment. Avoid contact with eyes.
Adverse Reactions
Hypersensitivity reactions in the form of rashes and irritation may occur. Systemic effects include mild gastrointestinal upsets, jaundice and changes in liver function; normal liver function is usually restored when treatment is stopped; Venospasm, thrombophlebitis, haemolysis, hypocalcaemia and tissue necrosis.
Drug Interactions
Although the exact metabolic pathways of Fusidate are not known, an interaction has been suspected with drugs metabolized by the hepatic cytochrome P450 isoenzyme CYP3A4.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
D06AX01 - fusidic acid ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Presentation/Packing
Oint 2% x 5 g, 10 g, 15 g x 1's.
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