RiteMED Aciclovir Special Precautions

Use with caution in patients with renal impairment and elderly patients [see Use in Patients with Renal Impairment and Use in the Elderly as follows].
Caution should be exercised when administering aciclovir to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous aciclovir [see Adverse Reactions].
Patients with genital herpes receiving aciclovir therapy should be advised that the drug is not a cure for genital herpes and therefore, should avoid sexual contact while visible lesions are present since there is a risk of transmitting the infection to their sexual partner.
Care should be taken to maintain adequate hydration in patients receiving high doses of aciclovir.
Effects on Ability to Drive and Use Machines: None reported.
Use in Patients with Renal Impairment: Aciclovir is eliminated by renal clearance; therefore the dose must be reduced in patients with renal impairment. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Mutagenic changes and chromosomal damage have occurred in vitro in human lymphocytes and mouse lymphoma cells at aciclovir concentrations at least 25 times greater than plasma concentrations achievable with usual dosage in humans. In other in vitro microbial and mammalian cell assays, no evidence of mutagenicity or inconclusive results were observed. Aciclovir was tested in 16 in vitro and in vivo genetic toxicity assays and was positive in 5 of these assays.
Evidence of mutagenicity or carcinogenicity in humans have not been reported.
Aciclovir did not impair fertility or reproduction in mice given 450 mg/kg/day orally or in rats 25 mg/kg/day subcutaneously (SC). However, at higher doses (50 mg/kg/day SC), implantation efficacy, but not litter size, was decreased. In peri- and post-natal studies in rats, higher doses also resulted in significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.
No testicular abnormalities were seen in dogs given aciclovir 50 mg/kg/day IV for one month or aciclovir 60 mg/kg/day orally for one year. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels.
Use in Children: Safety and efficacy of oral aciclovir in children younger than 2 years old have not been established.
Use in the Elderly: Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients.