Zovirax Ophthalmic Ointment
PDF Leaflet Revision Date: 1 March 2013
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of herpes simplex keratitis.
Dosage (summary)
10 mm ribbon in lower conjunctival sac, five times daily.
Pregnancy & Breastfeeding
Safety not established; passes into breast milk.
Key Drug Interactions
- Probenecid increases acyclovir half-life.
Contraindications
- Hypersensitivity to acyclovir or valaciclovir.
Common side effects
- Superficial punctate keratopathy
- Transient mild stinging
- Conjunctivitis
Counselling Points
- Inform about potential stinging.
- Avoid contact lenses while using.
Serious warnings
- Transient mild stinging may occur.
- Avoid contact lenses during use.
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ZOVIRAX Ophthalmic Ointment is indicated for the treatment of herpes simplex keratitis.
4.2 Posology and method of administration
Dosage for all age groups is the same. A 10 mm ribbon of the ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals. Treatment should continue for at least three days after healing.
4.3 Contraindications
ZOVIRAX Ophthalmic Ointment is contra-indicated in patients known to be previously hypersensitive to acyclovir or valaciclovir.
4.4 Special warnings and precautions for use
Patients should be informed that transient mild stinging immediately following application of ZOVIRAX Ophthalmic Ointment may occur. Patients should avoid wearing contact lenses when using ZOVIRAX Ophthalmic Ointment.
4.5 Interactions with other medicines
Probenecid increases the acyclovir mean half-life and area under the plasma concentration curve. Other medicines affecting renal physiology could potentially influence the pharmacokinetics of acyclovir. However, clinical experience has not identified other drug interactions with acyclovir.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not been established. Pregnancy: A post-marketing acyclovir 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 ZOVIRAX-exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Fertility: There has been no experience of the effect of ZOVIRAX Ophthalmic Ointment on human fertility. However, in two generation mouse studies no effects on fertility have been demonstrated. Lactation: Human data show that the acyclovir does pass into breast milk.
4.7 Effects on ability to drive and use machines
No specific information provided in the text.
4.8 Undesirable effects
The following convention has been used for the classification of undesirable effects in terms of frequency: very common u22651/10, common u22651/100 and <1/10, uncommon u22651/1 000 and <1/100, rare u22651/10 000 and <1/1 000, very rare <1/10 000. Eye disorders: Very Common: superficial punctate keratopathy. This did not necessitate an early termination of therapy and healed without apparent sequelae. Common: transient mild stinging of the eye occurring immediately following application, conjunctivitis. Local irritation and inflammation, such as blepharitis and conjunctivitis, have been reported in patients receiving ZOVIRAX Ophthalmic Ointment. Immune System disorders: Very rare: immediate hypersensitivity reactions including angioedema.
4.9 Overdose
No untoward effects would be expected if the entire content of the tube containing 135 mg of acyclovir were ingested orally. Acyclovir is dialysable by haemodialysis.
