Zovirax Ophthalmic

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Aciclovir 3%{relative}

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Aciclovir 3% w/w

Dosage:

3% w/w

Pharmaceutical form:

Eye ointment

Composition:

Active: Aciclovir 3%{relative} Excipient: White soft paraffin

Units in package:

Tube, 4.5 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Treatment of Herpes simplex keratitis.

Product summary:

Package - Contents - Shelf Life: Tube, - 4.5 g - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1982-11-18

Patient Information leaflet

 
1 
ZOVIRAX
®
 _(ZO-VI-RAX)_ 
OPHTHALMIC (EYE) OINTMENT 
ACICLOVIR 3%W/W 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about
ZOVIRAX eye ointment.  It does not contain all the 
available information. It does not
take the place of talking to your doctor or pharmacist. 

Please read this leaflet before you start using ZOVIRAX eye ointment.  If you are helping someone else use 
ZOVIRAX eye ointment, please read this leaflet before you use it
the first time. 

All medicines have risks and benefits. Your doctor has weighed the expected benefits against
possible risks of 
you using ZOVIRAX eye ointment.  If you have any concerns about using this medicine, ask your doctor or 
pharmacist. 

Keep this leaflet with the medicine. You may need to read it
again. 
WHAT ZOVIRAX EYE OINTMENT IS USED FOR 
ZOVIRAX eye ointment is an antiviral used to treat
an eye infection called Herpes simplex keratitis. This is a 
viral infection in the eye. It
is NOT used in other infections in the eye such as
conjunctivitis. 

This medicine is available only with a doctor’s prescription. 
BEFORE YOU USE ZOVIRAX EYE OINTMENT 
_DO NOT USE ZOVIRAX EYE OINTMENT IF: _
  you have an allergy to ZOVIRAX eye ointment, acyclovir, valaciclovir or any of the ingredients listed at the 
end of this leaflet. 
  the packaging is torn or shows signs of tampering, or the ointment
has changed colour. 
  the expiry date (EXP) printed on the pack has passed. 
If you use this medicine after the expiry date has
passed, it may not work. 
  it is more than a month after you first
opened the tube of ointment. 

If you are not sure whether you should start using ZOVIRAX eye ointment, contact your doctor. 

Do not give this medicine to anyone else.  Your doctor has

Summary of Product characteristics

1
DATA SHEET
ZOVIRAX OPHTHALMIC OINTMENT.
_ACICLOVIR 3% W/W OPHTHALMIC OINTMENT_
PRESENTATION
A near-white translucent eye ointment containing 3%w/w aciclovir in a sterile, 
anhydrous, soft paraffin base.
_NATURE AND CONTENTS OF CONTAINER:_
Tube with nozzle and screw cap: 4.5g.
USES
_ACTIONS:_
Aciclovir is an antiviral agent which is highly active _in
vitro _against Herpes 
simplex (HSV) types I and II and Varicella zoster viruses, but its
toxicity to 
mammalian cells is low.
Aciclovir is phosphorylated to the active compound aciclovir
triphosphate after 
entry into a herpes infected cell. The first step in this process
requires 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.
_PHARMACOKINETICS:_
Aciclovir is rapidly absorbed from the ophthalmic ointment through the
corneal 
epithelium and superficial ocular tissues with the result that viral
toxic 
concentrations are achieved in the aqueous humor. It has not been
possible 
to detect aciclovir in the blood by existing methods after topical
application of 
ZOVIRAX Ophthalmic Ointment, but trace quantities are detectable in
the 
urine. These levels, however, are not therapeutically significant.
_INDICATIONS:_
ZOVIRAX Ophthalmic Ointment is indicated for the treatment of Herpes 
simplex keratitis.
DOSAGE AND ADMINISTRATION 
2
The dosage for all age groups is the same.
A 10mm 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 3 days after healing.
CONTRAINDICATIONS 
ZOVIRAX Ophthalmic Ointment is contraindicated in patients known to
be 
hypersensitive to aciclovir or valaciclovir.
WARNINGS AND PRECAUTIONS 
Patients should be informed that transient mild stinging immediately
following 
application may occur.
Pati