COMPOSITION :
KANSEL - B Cream
Clotrimazole (I.P) 1.00% w/w
Becloamethasone
Dipropionate (I.P) 0.025% w/w
In Propylene glycol base
KANSEL - B Lotion
Clotrimazole 1.0%w/v
Beclomethasone
(as Dipropionate) 0.025% w/v
In Non-Aqueous base
CLINICAL PHARMACOLOGY :
Clotrimazole in KANSEL - B belongs to the imidazole group of antifungals, having broad-spectrum activity against pathogenic dermatophytes (Tinea) and yeasts (Candida). Clotrimazole inhibits the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells. This action alters the permeability of fungal cell walls. At higher concentration there is an additional mechanism of membrane damage unrelated to sterol synthesis. It also has some action against certain gram-positive bacteria, especially staphylococci, and against Trichomonas. Beclomethasone dipropionate falls under the category of Very Potent Corticosteriods with a vasconstrictor potency index of 1660.due to double esterification at positions 17 & 21, Beclomethasone dipropionate(in Kansel-B) becomes very lipophilic thereby offering
- better penetration
- more affinity to the cytosol receptors for potent action.
Beclomethasone enhances the action of clotrimazole in Kansel-B, by causing less rapid wash out of clotrimazole in the dermal circulation (this is due to vasoconstrictive activity of Beclomethasone).
INDICATIONS :
KANSEL -B is indicated for the management of fungal infection presenting with itch (with inflammatory manifestations). KANSEL - B Lotion is specially suited for application on hairy, intertriginous and large skin areas.
DOSAGE AND ADMINISTRATION :
B.I.D.- A thin layer of Gel/Lotion to be applied over the infected area twice daily for 2 weeks or as directed.
CONTRAINDICATIONS :
Hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS : Not for ophthalmic use. Limit to less than 45g.per week.
ADVERSE REACTIONS :
With Clotrimazole following adverse reactions are rare: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning and general irritation of skin. With Betamethasone Dipropionate burning, itching, irritation, dryness, folliculitis, skin atrophy, erythema, numbness of fingers and telangiectasia occurs infrequently. If signs of hypersensitivity occur, treatment should be immediately stopped. As treatment is short term, chances of these adverse effects of Betamethasone is rare.
STORAGE INSTRUCTIONS : Store in a cool, dry place.