Fusidasol

Fusidasol

betamethasone + fusidic acid

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Contents
Fusidic acid, betamethasone dipropionate.
Description
Each gram contains fusidic acid 2% w/w, betamethasone dipropionate 0.05% w/w, methyl paraben (as preservative) 0.1% w/w and propyl paraben (as preservative) 0.1% w/w.
Action
Pharmacology: Pharmacodynamics: This product combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of betamethasone. Betamethasone is a topical steroid with rapid effect in inflammatory dermatoses. Even refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphylococci, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides.
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 does not enter cerebrospinal fluid in appreciable amounts. It has been found in the foetal circulation and in breast milk. About 95% or more of Fusidic Acid in the circulation is bound to plasma protein. Fusidic Acid 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 have 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 the plasma proteins. Only unbound corticosteroid has pharmacological effects or is metabolised. They are metabolised mainly in the liver, also in the kidney, and are excreted in the urine.
Indications/Uses
Inflammatory dermatoses, psoriasis where bacterial infection caused by staphylococcus and streptococcus are present or likely to occur.
Dosage/Direction for Use
After washing, apply to the affected area twice daily as directed by your doctor or pharmacist.
Mode of Administration: To be applied topically,
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Contraindications
Hypersensitivity to any component.
Topical corticosteroids are contra-indicated in viral, tuberculous, fungal skin infections, perioral dermatitis, acne rosacea and ulcerative condition.
Special Precautions
Long term continuous therapy should be avoided, particularly in the face, on flexures, intertrigenous areas, infants and children.
Use In Pregnancy & Lactation
Topical steroids should not be used extensively in pregnancy, fetal abnormalities, have been seen in animals due to systemic absorption
Adverse Reactions
Hypersensitivity has rarely been encountered. As with other topical corticosteroids, prolonged intensive treatment may cause local atrophic changes of the skin, such as striae, thinning and dilatation of the superficial blood vessels, particularly when occlusive dressing is used or when the skin folds are involved. Systemic absorption, sufficient to produce hypercorticism/adrenal suppression, can occur with prolonged or extensive use, especially when used under occlusion/napkin.
Infants and children are particularly at risk.
Caution should be exercised if a topical steroid is used near eye. Glaucoma might be the result if the preparation enters the eye.
Drug Interactions
No known drug interaction to date.
Storage
Store at temperature below 30°C.
Shelf-Life: 2 years.
MIMS Class
Topical Anti-Infectives with Corticosteroids
ATC Classification
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Presentation/Packing
Form
Fusidasol cream
Packing/Price
10 g x 1's;15 g x 1's
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