1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Tel: 01-773-1473, 01-8179648, 08033160649
Micro Labs Limited, 92 Sipcot, Hosur-635 126, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Cream (NRN:04-2920): Clotrimazole 1%, Beclomethasone dipropionate 0.25%, Gentamicin 0.1%.
Pack size: 30 g aluminum tubes.
Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes and Malassezia furfur. The primary action of Clotrimazole is against dividing and growing organisms.
In vitro, Clotrimazole exhibit fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidemophyton floccosum and Microporum canis.
Beclomatosone dipropionate: Beclomathasone dipropionate, a corticosteroid, is effective in the treatment of corticosteroid-responsive dermatoses primarily because of its anti-inflammatory, antipruritic, and vasoconstrictive actions.
Gentamicin Sulfate: Gentamicin sulfate, a wide-spectrum antibiotic, provides highly effective topical treatment in primary and secondary bacterial infections of the skin.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin; inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids are also excreted into the bile.
Visita Plus cream is used in all commonly encountered dermatoses with bacteria and/or fungal infection, mixed dermatoses, contact dermatitis, atopic dermatitis (eczema), chronic otitis externa, Candidiasis and napkin rash.
Visita Plus cream is contra-indicated in patients who are sensitive to Beclometasone dipropionate, Clotrimazole, Gentamicin sulfate, other corticosteroids or imidazole, or to any other ingredients in this preparation.
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
If irritation or hypersensitivity develops with the use of Visita Plus cream, treatment should be discontinued and appropriate therapy instituted.
Pregnancy category (US FDA): Category C: Should be used in pregnant women only if the potential benefit justifies the potential risk to the foetus.
Drug interactions have not been reported. However, check with your doctor or pharmacist before use to ensure that the combination is safe. Especially pay attention to cancer chemotherapy agents, other topical medications and vitamins.
The local adverse effect reported infrequently are burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary peeling edema, pruritus, urticaria, and general irritation of the skin.
Dosage & Administration
Gently massage sufficient Visita Plus cream into the affected and surrounding skin area twice a day, in the morning and evening. For two weeks in tinea cruris and tinea corporis; and for four weeks in tinea pedis. The use of Visita Plus cream for longer than four weeks is not recommended.
Acute overdosage with topical applications of Visita Plus cream is unlikely and would not be expected to lead to a life-threatening situation.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce system effects.
Store between 2oC and 30oC.
Keep away from the reach of children.