COMPOSITION :
KANSEL- MP Mouth Paint
Clotrimazole 1% w/v
In Non-Aqueous base
CLINICAL PHARMACOLOGY :
Clotrimazole 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.
In KANSEL-MP , which is meant to be applied on oral mucosal surface, the role of Clotrimazole is against Candida albicans, the yeast affecting the mucosal lining especially of neonates and infants.
INDICATION :
1. KANSEL-MP (Clotrimazole1% mouth paint) is indicated for the management of Oral Thrush in Children
2. In adults, for the treatment of Oral Thrush which is associated with
(a) Dentures
(b) Prolonged Antibiotic therapy
(c) AIDS
(d) Radiotherapy
(e) Long-term Steroid Treatment
3. Angular stomatitis, Perleche (Angular Chelitis).
DOSAGE AND ADMINISTRATION :
TID or QID: three or four times daily.
Application instructions:
10-20 drops to be gently applied to mouth, preferably with cotton bud, 3-4 times a day. All lesions in the mouth must be covered.
CONTRAINDICATIONS :
Hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS :
Not for ophthalmic use.
ADVERSE REACTIONS :
Nausea and vomiting may be seen at doses above 200mg daily.
STORAGE INSTRUCTIONS :
Store in a cool, dry place.