Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Crawford Healthcare Ltd, Kind Edward Court, Kind Edward Road, Knutsford, Cheshire, WA16 0BE, United Kingdom
Pharmacotherapeutic group: Anti-infectives for treatment of acne
ATC code: D10AF01
Zindaclin contains clindamycin phosphate which is hydrolysed in the skin to the active constituent clindamycin. Clindamycin is a lincosamide antibiotic with primarily bacteriostatic action against Gram positive aerobes and wide range of anaerobic bacteria.
When clindamycin phosphate is applied cutaneously, clindamycin is found in comedone samples at sufficient levels to be active against most strains of Propionibacterium (P. acnes). It thus reduces the number of surface and follicular P.acnes, one of the aetiological factors of the disease.
As with all antibiotics, the long-term use of cutaneous clindamycin may lead to resistance.
The Zindaclin formulation results in a reduction in the extent of systemic absorption of clindamycin. An in vitro study with Zindaclin with normal human skin has shown the in vitro absorption of radiolabelled clindamycin phosphate from the Zindaclin formulation to be less than 5% of the applied dose.
When Zindaclin is applied cutaneously, to patients with acne, at 8g/day for 5 days, i.e. levels well in excess of the maximum anticipated clinical dose a very small amount, (median less than 2ng/ml) of clindamycin was measured in plasma.
Clindamycin phosphate is metabolised to the parent drug in the skin and clindamycin itself is primarily metabolised in the liver via N-demethylation, sulphoxidation and hydrolysis and predominantly excreted in the bile.
Preclinical data for clindamycin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction.
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