Vitara Beta-C

Clotrimazole, betamethasone.

White cream.
Each 100 g contains Clotrimazole 1.0 g, Betamethasone dipropionate equivalent to Betamethasone 0.1 g.

Pharmacology: Pharmacodynamics: Clotrimazole alters cell membrane permeability by binding with phospholipids in the fungal cell membrane. Alteration of permeability causes the cell membrane unable to function as a selective barrier, and potassium and other cellular constituents are lost, thereby inhibiting growth of fungi.
Following topical application, corticosteroids produce anti-inflammatory, antipruritic, and vasoconstrictor actions. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, prevent release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.
Pharmacokinetics: Absorption: Very small amounts of clotrimazole appear to be absorbed systemically following topical application to the skin. Percutaneous absorption of betamethasone dipropionate may be increased when applied on the inflamed skin. Occlusive dressings substantially increase the percutaneous absorption of topical betamethasone dipropionate.
Distribution: Following application to the skin, highest concentrations of clotrimazole are present in the stratum corneum; lower drug concentrations occur in the stratum spinosum and the papillary and reticular dermis. Betamethasone dipropionate is bound to plasma proteins.
Metabolism: Clotrimazole is metabolised in the liver to inactive compounds. Betamethasone dipropionate is also metabolised in the liver.
Elimination: Clotrimazole is excreted in the faeces and urine. Corticosteroids are excreted by the kidneys. Some topical corticosteroids and their metabolites are excreted in bile.

VITARA BETA-C is indicated for the treatment of dermal fungal infections such as tinea pedis, tinea cruris and tinea corporis caused by Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum and Candidiasis due to Candida albicans.

Recommended Dose: Tinea corporis & Tinea cruris: Twice daily, morning and evening for 1 week; re-evaluate after 1 week if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 2 weeks.
Tinea pedis: Twice daily, morning and evening for 2 weeks; re-evaluate after 2 weeks if no clinical improvement; maximum dose: 45 g cream per week; maximum duration: 4 weeks.
Candidiasis: Twice daily, morning and evening; re-evaluate after 2 weeks if no clinical improvement.
Mode of Administration: Massage into affected area of the skin.

Overdose and Treatment: VITARA BETA-C should not be used more than 45 grams per week or for longer than prescribed time period. Acute overdosage with topical application is unlikely and would not be expected to lead to a life-threatening situation. However, it can be absorbed in sufficient amounts to produce systemic effects.

VITARA BETA-C is contraindicated in patients with previously demonstrated hypersensitivity to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or any component of the product.

If skin irritation occurs, treatment should be discontinued and the patient should consult a physician or pharmacist.
This drug contains corticosteroids. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria. Avoid using this drug on large areas of the body, on the broken skin, for prolonged periods of time, with an occlusive dressing, or in infants and children <17 years of age, since these conditions can lead to a greater risk of adverse systemic corticosteroids effects.
The use of VITARA BETA-C is not recommended in the treatment of diaper dermatitis.

Pregnancy: There are no adequate data related to use in pregnant women. However, teratogenic effects of corticosteroids have been observed in animal studies. Use only if potential benefit outweighs risk.
Lactation: Absorption of clotrimazole from skin is minimal. It is not known if measurable amounts of clotrimazole appears in human milk. Systemic administered corticosteroids appear in human milk and could cause systemic side effects. It is not known if topical corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. VITARA BETA-C should be used with caution in nursing women.

Adverse Dermatologic Effects: Paresthesia, edema, secondary infection, blistering, erythema, pruritus, burning, urticaria, skin irritation, contact dermatitis, skin dryness, skin atrophy, striae, hypopigmentation.
Adverse Systemic Corticosteroid Effects: When this drug is used on large areas of the body, on the broken skin, for prolonged periods of time, with an occlusive dressing, or in infants and children <17 years of age, reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria may occur.

Topical clotrimazole may increase serum concentration of Sirolimus.
Topical clotrimazole may increase serum concentration of Tacrolimus (systemic).

Store at the temperature below 30°C.

Topical Anti-Infectives with Corticosteroids

D01AC20 - imidazoles/triazoles in combination with corticosteroids ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.

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