Included as part of the "PRECAUTIONS" Section
Patient Counseling Information
Advise patients to read the FDA-approved patient labelling.
Advise patients to wash hands well and pull down lower lid of the affected eye to form a pocket. Instruct the patient to apply a 1
cm (1/2 inch) ribbon of ointment in the pocket formed by the lower lid 5 times per day (approximately every 3 hours while awake).
After application of the ointment, the patient should be advised to close their eye for 1-2 minutes. Excess ointment can be wiped
away. Continue this dosing 5 times per day until the patient is advised by their physician that the corneal ulcer is healed. Once
healed, instruct the patient to continue use of a 1 cm (1/2 inch) ribbon of ointment 3 times per day for 7 more days. [see DOSAGE AND ADMINISTRATION].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Acyclovir was not shown to be carcinogenic in mouse and rat bioassays at oral doses up to 450mg/kg (approximately 1100 –
2200 times the maximum RHOD, on a mg/m2 basis, assuming 100% absorption).
Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was found to be negative in the Ames test,
positive in the in vitro mouse lymphoma assay (TK locus), and positive in the in vitro and in vivo assays for chromosomal effects.
In reproduction studies, acyclovir did not impair fertility or reproduction at oral doses up to 450 mg/kg/day in mice (1100 times the
RHOD), or at subcutaneous doses of 25 mg/kg/day in rats (125 times the RHOD). At a dose of 50 mg/kg/day in rats and rabbits
(250 and 500 times the RHOD, respectively), implantation efficiency was decreased.
Use In Specific Populations
A prospective epidemiologic registry of acyclovir use from 1984 to 1999 indicated that the occurrence rate of birth defects in
women exposed to systemically administered acyclovir during the first trimester of pregnancy (period of organogenesis)
approximated that found in the general population. Likewise, oral and subcutaneous administration of acyclovir to pregnant mice,
rats, and rabbits during organogenesis did not produce teratogenicity at clinically relevant doses [see Animal Data].
A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999.
There were 749 pregnancies followed in women exposed to systemically administered acyclovir during the first trimester of
pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population.
However, the small size of the registry is insufficient to evaluate the risk for less common defects, or to permit reliable or
definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. The human maternal
plasma level of acyclovir following ocular administration is unknown.
In published animal reproduction studies, acyclovir was not maternally toxic and did not produce teratogenicity in the mouse at
oral doses up to 450 mg/kg/day (1100 times the maximum recommended human ophthalmic dose [RHOD] on a mg/m2 basis,
assuming 100% absorption), or in the rat and rabbit at subcutaneous doses up to 50 mg/kg/day (approximately 250 and 500
times the RHOD, respectively) when administered throughout the period of organogenesis.
Administration of acyclovir from postnatal days 3 to 21 did not produce adverse effects in neonatal rats at subcutaneous doses
less than or equal to 20 mg/kg/day (100 times the RHOD).
Acyclovir concentrations have been documented in breast milk following oral administration of acyclovir There is no information
regarding the presence of acyclovir in human milk following ocular administration, the effects on the breastfed infant, or the
effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the
mother’s clinical need for acyclovir, and any potential adverse effects on the breast-fed child from acyclovir or from the
underlying maternal condition.
Safety and efficacy of Acyclovir ophthalmic ointment in pediatric patients below the age of two years has not been established.
No overall differences in safety or effectiveness have been observed between elderly and other adult patients..