CYCLOVAX Cream Ref.[28212] Active ingredients: Aciclovir

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotics and Chemotherapeutics for dermatological use; Chemotherapeutics for topical
ATC code: D06BB03

Aciclovir is an antiviral agent which is highly active in vitro against herpes simplex virus (HSV) types I and II and varicella zoster virus. Toxicity to mammalian host cells is low.

Aciclovir is phosphorylated after entry into herpes infected cells to the active compound aciclovir triphosphate. The first step in this process is dependent on the presence of the HSV-coded thymidine kinase.

Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes-specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes.

5.2. Pharmacokinetic properties

Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of aciclovir cream.

5.3. Preclinical safety data

Fertility

There is no information on the effect of aciclovir oral formulations or IV for infusion on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

Non-clinical information

Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man.

Carcinogenicity

Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.

Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of aciclovir greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.

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