COMPOSITION :
TRION - B Gel
Beclomethasone
(as Dipropionate) 0.025% w/w
Clotrimazole 1.0% w/w
Gentamicin
(as Sulphate) 0.1% w/w
In Propylene glycol base
CLINICAL PHARMACOLOGY :
The primary therapeutic effect of Betamethasone dipropionate is due to the anti-inflammatory activity which is nonspecific. Topically applied glucocorticoids like Betamethasone dipropionate binds with receptor proteins in the cytoplasm of target cells. This leads to the formation of phospholipase A2 inhibitory proteins, collectively called lipocortins. Phospholipase A2 is known to catalyse the conversion of membrane phospholipids to Arachidonic acid. Arachidonic acid binds with cyclo-oxygenase to form highly inflammatory prostaglandins, PGE2. Lipocortins inhibits phopholipase A2, and thereby controls the biosynthesis of potent mediators of inflammatory like prostaglandin E2 (PGE2) and leukotrienes, kinins, histamine, liposomal enzymes and the complement system. When applied to inflamed area of skin Betamethasone dipropionate inhibits the migration of leukocytes into the area by reversing vascular dilatation and permeability. The clinical result is a decrease in edema (swelling), erythema and pruritus. (Betamethasone dipropionate falls under the category of very potent corticosteroids with a vasconstrictor potency index of 500).
Clotrimazole in TRION 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. Gentamicin in TRION is an aminoglycoside antibiotic which interferes with protein synthesis in susceptible bacteria. Gentamicin offers a broad spectrum of cover against gram negative bacteria such as E Coli, Enterobacter, Klebsiella, Salmonella, Serratia, Shigella, some proyeins, and unlike Kanamycin and Nromycin against Pseudomonas aeruginosa. Among the gram positive bacteria, Staphylococcus aureus is highly sensitive to Gentamicin with MIC (Minimum Inhibitory Concentration) in the range of 0.0125 to 0.1 mcg./ml.
INDICATIONS :
TRION is indicated in inflammatory dermatoses complicated by fungal and bacterial infections.
DOSAGE AND ADMINISTRATION :
B.I.D.-Apply thin layer of TRION Gel to the affected area twice daily till inflammatory dermatoses is controlled.
CONTRAINDICATIONS :
Hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS :
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 Beclomethasone Dipropionate burning, itching etc. With Gentamicin, erythema and pruritus have known to occur rarely.
STORAGE INSTRUCTIONS :
Store in a cool, dry place.