Zovirax Cream（GlaxoSmithKline UK）
1. Name of the medicinal product
Zovirax® Cream
2. Qualitative and quantitative composition
Aciclovir BP 5.0% w/w
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Topical Cream
4. Clinical particulars
4.1 Therapeutic indications
Zovirax Cream is indicated for the treatment of Herpes Simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.
Route of administration: topical.
Do not use in eyes.
4.2 Posology and method of administration
Adults and Children: Zovirax Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application.
Zovirax Cream should be applied to the lesions or impending lesions as soon as possible, preferably during the early stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages.
Treatment should be continued for at least 4 days for herpes labialis and for 5 days for genital herpes. If healing has not occurred then treatment may be continued for up to an additional 5 days.
Use in the elderly: No special comment
4.3 Contraindications
Zovirax Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of Zovirax Cream listed in section 6.1.
4.4 Special warnings and precautions for use
Zovirax Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant.
Particular care should be taken to avoid accidental introduction into the eye.
In severely immunocompromised patients (eg AIDS patients or bone marrow transplant recipients) oral Zovirax dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection.
The excipient propylene glycol can cause skin irritations and the excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis).
Zovirax Cream contains a specially formulated base and should not be diluted or used as a base for the incorporation of other medicaments.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified.
4.6. fertility, pregnancy and breast-feeding
Pregnancy:
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. 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.
The use of Zovirax Cream should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of Zovirax Cream is very low.
Teratogenicity:
Effects in non-clinical studies were obse
