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Product
Antiretroviral products (Acivir Eye Ointment )
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Antiretroviral products (Acivir Eye Ointment )
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Acivir Eye Ointment Acyclovir Eye ointment
COMPOSITION
Acyclovir BP 3% w/w
Benzalkonium chloride NF 0.01% w/w
DOSAGE FORM
Eye ointment
PHARMACOLOGY
Pharmacodynamics
Acyclovir is an antiviral agent which is highly active in vitro against herpes simplex (HSV) types I and II, but its toxicity to mammalian cells is low.
Acyclovir is phosphorylated to the active compound acyclovir triphosphate after entry into herpes infected cell. The first step in this process requires the presence of the HSV coded thymidine kinase. Acyclovir triphosphate acts as an inhibitor of, and substrate for, herpes specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes.
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Pharmacokinetics
Acyclovir is rapidly absorbed from the ophthalmic ointment through the corneal epithelium and superficial ocular tissues, achieving antiviral concentrations in the aqueous humor. It has not been possible by existing methods to detect acyclovir in the blood after topical application to the eye. However, trace quantities are detectable in the urine. These levels are not therapeutically significant.
INDICATIONS
Treatment for herpes simplex keratitis.
DOSAGE AND ADMINISTRATION
Adults
I cm 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.
CONTRAINDICATIONS
Hypersensitivity to any components of this medication.
WARNINGS AND PRECAUTIONS
Drug Interactions
Probenecid increases the acyclovir mean half-life and area under the plasma concentration curve of systemically administered acyclovir. Other drugs affecting renal physiology could potentially influence the pharmacokinetics of acyclovir.
However, clinical experience has not identified drug interactions with ophthalmic acyclovir.
Pregnancy
The use of Acyclovir ophthalmic ointment should be considered only when the potential benefits outweigh the possibility of unknown risk.
Lactating Women
The use of Acyclovir ophthalmic ointment should be considered only when the potential benefits outweigh the possibility of unknown risk to a lactating woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established
UNDESIRABLE EFFECTS
Transient mild stinging immediately following application may occur in a small proportion of patients. Superficial punctate keratopathy has been reported but has not resulted in patients being withdrawn from therapy and healing has occurred without apparent sequelae. Local irritation and inflammation such as blepharitis and conjunctivitis have also been reported.
OVERDOSAGE
No untoward effects would be expected if the entire contents of the tube containing 135 mg of Acyclovir were ingested orally. Oral doses of 800 mg five times daily (4 g per day) have been administered for seven days without adverse effects.
Single intravenous doses of up to 80 mg/kg have been inadvertently administered without adverse effects. Acyclovir is dialyzable by haemodialysis.
INCOMPATIBILITY
Not applicable.
SHELF-LIFE
2 years
STORAGE AND HANDLING INSTRUCTIONS
Store at 15-250 C in a dry place
PACKAGING INFORMATION
Acivir Eye Ointment.................................... Tube of 5 g
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