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Betamethasone+ Clotrimazole + gentamycin
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Composition
Betamethasone+ Clotrimazole + gentamycin U.S.P. 0.064 % w/w
Gentamicin Sulphate B.P. equivalent to Gentamicin 0.1 % w/w
Clotrimazole U.S.P. 1.0 % w/w
Cream Base q.s.
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Indications:
The cream is indicated for the topical treatment of the
following dermal infections:
- dermatosis, complicated by primary and second infection;
- Tinea pedis, Tinea cruris, Tinea corporis due to
Trichophyton rubrum, Trichophyton
mentagrophytes, Epidermophyton floccusum, and Microsporum
canis
- dermatomycosis (in such cases inguinal), caused by agents
sensitive to the preparation.
Dosage and Administration:
Gently massage sufficient Cream into the affected and
surrounding skin areas twice a day, in the morning and
evening, for 2 weeks in tinea cruris and tinea corporis and
for 4 weeks in tinea pedis.
Cream should not be used with occlusive dressings.
Contraindications:
Hypersensitivity to any of the components of the formulation.
WARNINGS & PRECAUTIONS:
If irritation or hypersensitivity develops with the use of the drug, Treatment should be discontinued and appropriate therapy instituted.The use of gentamicin may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs during gentamicin therapy, the drug should be discontinued and appropriate therapy instituted.
General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal(HPA) axis suppression., manifestation of Cushiing's syndrome, hyperglycemia, and glucosuria in some patients.The use of cream for longer than 4 weeks is not recommended.
PREGNANCY AND LACTATION:
There are no adverse effects with the combination gentamicin sulphate, clotrimazole and betamethasone dipropionate.
UNDESIRABLE EFFECTS:
Rarely patients may experience local mild burning or irritation immediately after applying the cream. Very rarely the patient may find this irritation intolerable and stop treatment
PHARMACOLOGICAL ACTION:
Betamethasone dipropionate, a corticosteroid, is effective in the treatment of corticosteroid-responsive dermatoses primarily because of its anti-inflammatory, anti-pruritic, and vasoconstrictive actions.
Gentamicin is active against a wide range of bacilli.Gentamicin binds irreversibly to the 30S subunit of the bacterial ribosome, blocking protein synthesis by inhibiting the movement of peptidyl-tRNA associated with translocation as well as increasing the frequency of misreading of the genetic code due to incorrect codon-anticodon interaction. The effect is bactericidal.
Clotrimazole is a broad spectrum antifungal agent available for topical use. It is active against yeasts & dermatophytes & also has some action against certain gram +ve bacteria.
STORAGE INSTRUCTIONS:
Store below 25°C, keep in a dry & dark place
NATURE AND CONTENTS OF CONTAINER:
An aluminium collapsible tube of 15 gm cream, packed in a Primary Carton along with the Pack Insert.
KEEP OUT OF REACH OF CHILDREN.KEEP OUT
FOR EXTERNAL USE ONLY.
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Presentation
15gm aluminium tube with plastic cap is packed in a printed
primary carton along with insert literature.
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