The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly see Dosage in renal impairment below. Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained.
Dosage in renal impairment: Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained. Administration Zovirax tablets are for oral administration and may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water.
Ensure that patients on high doses of aciclovir are adequately hydrated. Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment see 4. Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. 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.
In the reported cases, these reactions were generally reversible on discontinuation of treatment see 4. Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment see section 5.
Care should be taken to maintain adequate hydration in patients receiving high doses of aciclovir. The risk of renal impairment is increased by use with other nephrotoxic drugs. The data currently available from clinical studies is not sufficient to conclude that treatment with aciclovir reduces the incidence of chickenpox-associated complications in immunocompetent patients. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations.
Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance. Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppresant agent used in transplant patients have been shown when the drugs are coadministered.
However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir. It is recommended to measure plasma concentrations during concomitant therapy with aciclovir. The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing aciclovir 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.
There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in and completed in April There were pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 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.
Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0. Acyclovir should be administered to a nursing mother with caution and only when indicated. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects.
The duration of pain after healing was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction.
Elderly patients are also more likely to have renal or CNS adverse events. J Pediatr ; 4: Acyclovir treatment of varicella in otherwise healthy adolescents. J Pediatr ; 4 Pt 1: Viral resistance in clinical practice: Viral resistance, clinical experience.
Scand J Infect Dis Suppl ; Effect of acyclovir combined with other antiherpetic agents on varicella zoster virus in vitro.
Am J Med ; 73 1A: Multiple dose pharmacokinetics of intravenous acyclovir in patients on continuous ambulatory peritoneal dialysis. J Antimicrob Chemother ; 20 1: Treatment of first episodes of genital herpes simplex virus infection with oral acyclovir.
A randomized double-blind controlled trial in normal subjects. N Engl J Med ; Isolation and characterisation of resistant Herpes simplex virus after acyclovir therapy. Lancet ; 1 Christophers J, Sutton RN. Characterisation of acyclovir-resistant and -sensitive clinical herpes simplex virus isolates from an immunocompromised patient.
J Antimicrob Chemother ; 20 3: Varicella-Zoster virus does not become more resistant to acyclovir during therapy. J Infect Dis ; 3: Collins P, Bauer DJ. The activity in vitro against herpes virus of 9- 2-hydroxyethoxymethyl guanine acycloguanosine , a new antiviral agent. J Antimicrob Chemother ; 5 4: Collins P, Oliver NM. Sensitivity monitoring of herpes simplex virus isolates from patients receiving acyclovir. J Antimicrob Chemother ; 18 Suppl B: Viral sensitivity following the introduction of acyclovir.
Am J Med ; 85 2A: Characterization of a DNA polymerase mutant of herpes simplex virus from a severely immunocompromised patient receiving acyclovir. J Gen Virol ; 70 Pt 2: Growth inhibition by acycloguanosine of herpesviruses isolated from human infections. Antimicrob Agents Chemother ; 15 5: Resistance to antiviral drugs of herpes simplex virus isolated from a patient treated with acyclovir. N Engl J Med ; 6: Mechanisms of resistance to nucleoside analogue inhibitors of herpes simplex virus.
Comparative efficacy of antiherpes drugs against different strains of herpes simplex virus. J Infect Dis ; 5: Comparative efficacy of antiherpes drugs in different cell lines. Antimicrob Agents Chemother ; 21 4: Virus resistance in clinical practice.
J Antimicrob Chemother ; 12 Suppl B: A double-blind, placebo-controlled trial to the effect of chronically administered oral acyclovir on sperm production in men with frequently recurrent genital herpes. J Infect Dis Mar; Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered Zovirax, or they have any other questions.
Patients should be advised to maintain adequate hydration. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Patients should be informed that Zovirax is not a cure for genital herpes. There are no data evaluating whether Zovirax will prevent transmission of infection to others.
Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity.
Adolescents and adults tend to have more severe disease. Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors.
Acyclovir was positive in 5 of the assays. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in and completed in April There were pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in outcomes.
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