Foban

Foban

fusidic acid

Manufacturer:

Taisho

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Contents
Fusidic acid.
Description
White cream contains 2.0% w/w Fusidic Acid with 0.15% w/w Methyl paraben and 0.08% w/w Propyl paraben as preservatives.
Colourless ointment contains 2.0% w/w Sodium fusidate.
Action
Pharmacology: Pharmacodynamics: Fusidic acid and its salts exert antibacterial activity against most Gram positive organisms; in particular, they are effective against pathogenic Staphylococci, including the penicillinase-producing strains. It has slight or no activity against Gram negative organisms and fungi.
Pharmacokinetics: Fusidic acid and its salts are widely distributed into tissues and body fluids, including bone, pus, and synovial fluid; it penetrates cerebral abscesses but do not enter cerebrospinal fluid in appreciable amounts.They have been found in the foetal circulation and in breast milk. About 95% or more of Fusidic acid or Sodium fusidate in the circulation is bound to plasma protein. Fusidic acid or Sodium fusidate is excreted in the bile, almost entirely as metabolites, some of which have weak antimicrobial activity. About 2% appears unchanged in the faeces. Little is excreted in the urine or removed by haemodialysis.
Indications/Uses
Skin lesions primarily or secondarily infected with Staphylococcus or Streptococcus.
Dosage/Direction for Use
After washing, apply to the affected area twice daily as directed by the doctor or pharmacist.
Overdosage
Symptoms and treatment: Overdosage has not been known to occur during topical therapy with Fusidic acid or its salts.
Contraindications
Known hypersensitivity to Fusidic acid, its salts and propylene glycol.
Special Precautions
Use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms. If this occurs, or irritation or sensitization develops, treatment should be discontinued and appropriate therapy instituted. Fusidic acid topical preparations should not be used in or near the eyes because of the possibility of conjunctival irritation.
Use in Pregnancy and Lactation: Safety in the treatment of infections during pregnancy has not been established. If administration to pregnant patients is considered necessary, its potential benefits should be weighed against the possible hazards to the foetus. There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of Foban in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.
Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk, but with topical use the possible amount of drug present is unlikely to affect the infant.
Use In Pregnancy & Lactation
Safety in the treatment of infections during pregnancy has not been established. If administration to pregnant patients is considered necessary, its potential benefits should be weighed against the possible hazards to the foetus. There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of Foban in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.
Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk, but with topical use the possible amount of drug present is unlikely to affect the infant.
Adverse Reactions
Hypersensitivity reactions in the form of rashes and irritation may occur after the topical administration of Fusidates; rash is rare after systemic administration.
Drug Interactions
No synergy has been demonstrated in vitro in most studies between Fusidic acid and rifampicin or vancomycin, and antagonism of the effects of ciprofloxacin has been reported. Interactions with the penicillins are complex, with either antagonism of the effect of one or both agents, or lack of any effect. However, the combination of an antistaphylococcal penicillin with Fusidic acid may prevent the emergence of Fusidic acid-resistant staphylococcal mutants, and such combinations may be clinically effective.
Storage
Keep container well closed. Protect from strong light. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
MIMS Class
ATC Classification
D06AX01 - fusidic acid ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Presentation/Packing
Cream 2% w/w (white) x 5 g, 15 g. Oint 2% w/w (colourless) x 5 g, 15 g.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in