FUNBACT-A Cream Ref.[115688] Active ingredients: Betamethasone Clotrimazole Neomycin

Source: Registered Drug Product Database (NG)  Revision Year: 2019  Publisher: Bliss GVS Pharma Ltd., 102, Hyde Park, Saki Vihar Road, Andheri (East), Mumbai - 400 072

5.1. Pharmacodynamic properties

Betamethasone is an active corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis.

Neomycin sulphate is a broad spectrum, bactericidal antibiotic effective against the majority of bacteria commonly associated with skin infections.

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane

5.2. Pharmacokinetic properties

The extent of percutaneous absorption of topical corticosteroid 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.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

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