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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
30°C. For external use only. Keep out of reach of children.
Recommended shelf-life: 3 years.
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