Zovirax Cream

Zovirax Cream

aciclovir

Manufacturer:

GlaxoSmithKline Indonesia
Full Prescribing Info
Contents
Aciclovir.
Description
Zovirax Cream contains aciclovir in 5% w/w water-miscible base which includes propylene glycol.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: 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 1st step in this process is dependent on the presence of the viral-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.
Clinical Studies: There is no information on the effect of Zovirax Cream on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1 g/day for up to 6 months has been shown to have no clinically significant effect on sperm count, motility or morphology.
Pharmacokinetics: Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cream.
Toxicology: Preclinical Safety Data: 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.
Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.
Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic 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.
Indications/Uses
Treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.
Dosage/Direction for Use
Adults and Children: Zovirax Cream should be applied 5 times daily at approximately 4-hourly intervals, omitting the night time application.
Zovirax Cream should be applied to the lesions or impending lesions as early as possible after the start of an infection. It is particularly important to start treatment of recurrent episodes during the prodromal period or when the lesions 1st appear. Treatment should be continued for 5 days. If healing has not occurred, treatment may be continued for up to 10 days.
Overdosage
No untoward effects would be expected if the entire contents of a tube of Zovirax Cream containing aciclovir 500 mg were ingested orally.
Contraindications
Patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or to any of the excipients of Zovirax Cream.
Special Precautions
Zovirax Cream is not recommended for application to mucous membranes eg, in the mouth, eye or vagina, as it may be an irritant. Particular care should be taken to avoid accidental introduction into the eye.
Use in pregnancy & lactation: A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The birth defects described amongst Zovirax exposed subjects have not shown any uniqueness or consistent pattern to suggest a common cause.
The use of Zovirax Cream should be considered only when the potential benefits outweigh the possibility of unknown risks.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain. Limited human data show that the drug does pass into breast milk following systemic administration.
Use In Pregnancy & Lactation
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The birth defects described amongst Zovirax exposed subjects have not shown any uniqueness or consistent pattern to suggest a common cause.
The use of Zovirax Cream should be considered only when the potential benefits outweigh the possibility of unknown risks.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.
In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain. Limited human data show that the drug does pass into breast milk following systemic administration.
Adverse Reactions
The following convention has been used for the classification of adverse effects in terms of frequency: Very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000, very rare <1/10,000.
Skin and Subcutaneous Tissue Disorders: Uncommon: Transient burning or stinging following application of Zovirax Cream, mild drying or flaking of the skin, itching. Rare: Erythema.
Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than aciclovir.
Immune System Disorders: Very Rare: Immediate hypersensitivity reactions including angioedema.
Drug Interactions
No clinically significant interactions have been identified.
Caution For Usage
Instructions for Use and Handling: Dilution: Zovirax Cream contains a specially-formulated base and should not be diluted or used as a base for incorporation of other medicaments.
Storage
Do not store above 25°C. Do not refrigerate.
MIMS Class
ATC Classification
D06BB03 - aciclovir ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.
Presentation/Packing
Cream 5% (water-miscible, smooth, white cream) x 2 g x 1's, 5 g x 1's.
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