Zovirax Eye Ointment
GlaxoSmithKline UK Contact details
1. Name of the medicinal product
Zovirax® Eye Ointment
2. Qualitative and quantitative composition
Aciclovir 3.0% W/W
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ophthalmic Ointment
4. Clinical particulars
4.1 Therapeutic indications
Treatment of herpes simplex keratitis.
4.2 Posology and method of administration
Topical administration to the eye.
Adults: 1cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals, omitting the night time application. Treatment should continue for at least 3 days after healing is complete.
Children: As for adults
Use in the elderly: As for adults.
4.3 Contraindications
Zovirax eye ointment is contra-indicated in patients with a known hypersensitivity to aciclovir or valaciclovir, or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Patients should be informed that transient mild stinging immediately following application may occur.
Patients should avoid wearing contact lenses when using Zovirax Eye Ointment.
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 described amongst Zovirax 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 Eye Ointment should be considered only when the potential benefits outweigh the possibility of unknown risks.
Breast-feeding
Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by the nursing infant following maternal use of Zovirax Eye Ointment would be insignificant.
Fertility
There is no information on the effect of aciclovir 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.
See Clinical Studies in section 5.2.
4.7 Effects on ability to drive and use machines
Eye ointments can affect visual ability and therefore caution is advised when driving or using machines.
4.8 Undesirable effects
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
The frequency categories used are:
Very common
≥ 1/10,
Common
≥ 1/100 and < 1/10,
Uncommon
≥ 1/1,000 and <1/100,
Rare
≥ 1/10
