Fobancort Cream : A white cream
containing 2.0% w/w Fusidic Acid and 0.064% w/w Betamethasone Dipropionate
with 0.15 % w/w Methyl Partition and 0.08% Propyl Paraben as preservatives.
Fobancort Ointment : A colourless ointment containing 2.0% w/w Sodium
Fusidate and 0.064°1. w/w Betamethasone Dipropionate.
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. Betamethasone Dipropionate is a topically
active fluorinated corticosteroid which has anti-inflammatory anti-pruritic
and vasoconstrictive actions.
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
cerebrospinal 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.
Betamethasone Dipropionate has anti-inflammatory, anti-pruritic and
vasoconstrictive actions. When administered topically, particularly under
occlusive dressing or when the skin is broken, sufficient corticosteroid may
be absorbed to give systemic effects. Corticosteroids are extensively bound
to plasma proteins. Only unbound corticosteroids have pharmacological
effects or are metabolised. They are metabolised mainly .n the liver, also
in the kidneys, and are excreted in the urine.
psoriasis, where bacterial infection caused by staphylococcus and
streptococcus are present or likely to occur.
Sensitivity to Fusdic Acid and
its salts. Hypersensitivity to Betamethasone Dipropionate, other
corticosteroids, or any component in the base. Topical corticosteroids are
contraindicated in most viral infections of the skin, such as veccinia,
varicella and herpes simplex, also tuberculosis, acne rosacea, fungal skin
infections, perioral dermatitis and ulcerative condition.
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 penicillin 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.
Hypersensitivity reactions in the
form of rashes and irritation may occur after the topical administration of
Fusidates; rash is rare after systemic administration. Reported local
adverse reactions are burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruption, hypopigmentation, maceration of the
skin, secondary infection, skin atrophy, striae and miliria. Large doses of
corticosteroids may produce symptoms typical of hypersensitivity of the
adrenal cortex with moon face, sometimes with hirsutism, buffalo hump,
flushing, sometimes leading to a fully developed Cushing's Syndrome.
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. Do not use on children below 2 years except under medical
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 be detected 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. Corticosteroid
applied to the skin can be absorbed in sufficient amounts to produce
systemic effects. Special care must be taken when giving to paediatric
patients as systemic absorption can occur in topical administration causing
growth retardation. Thus suitable precautions should also be taken when
treating stasis dermatitis and other skin diseases with impaired
circulation. Long-term continuous topical therapy should be avoided.
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 Sodium Fusidate. Corticosteroid applied
to the skin can be absorbed in sufficient amount to produce systemic effect
such as hypothalamic-pituitary-adrenal axis suppression, manifestation of
Cushing's Syndrome. hyperglycaemia and glucosuria. If
hypothalamic-pituitary-adrenal axis suppression is found, then the drug
should be withdrawn, frequency of application reduced or a weaker steroid
used. Supplemental systemic corticosteroids may be required if signs and
symptoms of steroid withdrawal occur.
5g and 15g collapsible aluminium
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.