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Foban

Cream and Ointment

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

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. They have slight or no activity against Gram negative organisms and fungi.

 

PHARMACOLOGY

Fusidic acid and its salts are widely distributed into tissues and body fluids, including bone, pus, and synovial fluid; they penetrate cerebral abscesses but do not enter cerebospinal fluid in appreciable amounts. They have been found in 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

Skin lesions primarily or secondarily infected with Staphylococcus or Streptococcus.

 

CONTRAINDICATIONS

Known hypersensitivity to Fusidic acid, it salts and propylene glycol.

 

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.


ADVERSE EFFECTS

Hypersensitivity reactions in the form of rashes and irritation may occur after the topical administration of Fusidates; rash is rare after systemic administration.

 

PRECAUTIONS/WARNINGS

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.


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 the drug can penetrate the placental barrier and is detectable in the milk of nursing mothers. Safety of Sodium fusidate for the treatment of infections in women who are breast feeding has not been established.


RECOMMENDED DOSAGE

After washing, apply to the affected area twice daily as directed by your doctor or pharmacist.


SYMPTOMS AND TREATMENT FOR OVERDOSE AND ANTIDOTE(S)
Symptoms and treatment : Overdosage has not been known to occur during topical therapy with Fusidic acid or its salts.


PACKING

5g and 15g collapsible aluminium tubes.


STORAGE

Keep container well closed. Protect from strong light. Store below 30C. For external use only. Keep out of reach of children.


Recommended shelf-life: 3 years.

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