CLINDOXYL Gel Ref.[50617] Active ingredients: Benzoyl peroxide Clindamycin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2013  Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

5.1. Pharmacodynamic properties

Pharmacological classification: A 13.11 Acne preparations

Clindamycin is a lincosamide antibiotic with bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 23S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis. The action of clindamycin is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterial active clindamycin.

Clindamycin activity has been demonstrated against most strains of Propionibacterium acnes. Clindamycin in vitro inhibits all P acnes cultures tested (MIC 0,4 ยตg/ml). Benzoyl peroxide is keratolytic and an oxidising agent acting against Propionibacterium acnes, the organism implicated in acne vulgaris. Furthermore it is sebostatic, counteracting the excessive sebum production associated with acne.

5.2. Pharmacokinetic properties

In a maximised percutaneous absorption study the mean plasma clindamycin levels during a four week dosing period for CLINDOXYL GEL were negligible (0,043% of applied dose).

The presence of benzoyl peroxide in the formulation did not have an effect on the percutaneous absorption of clindamycin.

Radio-labelled studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Benzoic acid is mostly conjugated to form hippuric acid which is excreted via the kidneys.

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