Each tablet contains: Acyclovir 200 mg.
ZEVIN (Acyclovir) is a synthetic acyclic nucleoside analogue with in vitro inhibitory activity against Herpes simplex types 1 and 2 (HSV-1 and HSV-2), varicella-zoster, Epstein-Barr and cytomegalovirus. In cell cultures, the inhibitory activity of acyclovir for Herpes simplex virus is highly selective.
Acyclovir is poorly absorbed following oral administration, with peak plasma levels occuring in 1.7 hours. Acyclovir is metabolized in liver. Plasma protein-binding is low. The half-life is 3.3 hours. Approximately 14% of total dose excreted unchanged in urine. Absorption of acyclovir is usually slight following topical application to intact skin.
In disease skin (Herpes zoster), moderate plasma concentrations up to 0.28 mcg/ml have been reported in patients with normal renal function.
Approximately 9% of the total daily dose may be excreted in the urine.
For the treatment of Herpes simplex virus infections of the skin and mucous membranes, including initial and recurrent genital herpes.
For the suppression (prevention of recurrence) of Herpes simplex infections in immunocompetent patients.
For the prophylaxis of Herpes simplex infections in immune-compromised patients.
For the treatment of Varicella (Chickenpox) and Herpes zoster (Shingles) infections.
Dosage for treatment of Herpes simplex in adults: 200 mg ZEVIN five times daily for 5 days but in severe initial infections may have to be extended. In severely immune compromised patients or in patients with impaired absorption from the gut, the dose can be doubled to 400 mg.
Dosing should begin as early as possible after the start of an infection: For recurrent episodes this should preferably be during the prodromal period or when lesions first appear.
Dosage for suppression of Herpes simplex in adults: 200 mg ZEVIN four times daily or 400 mg ZEVIN two times daily therapy should be interrupted periodically at intervals of six to twelve months in order to observe possible changes in the natural history of the disease.
Dosage for prophylaxis of Herpes simplex in adults: 200 mg ZEVIN four times daily. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg.
The duration of prophylactic administration is determined by the duration of the period at risk.
Dosage for treatment of Varicella and Herpes zoster in adults:
800 mg ZEVIN five times daily for 7 days.
Dosing should begin as early as possible after the start of an infection: treatment yields better results if initialed as soon as possible after onset of the rash.
Dosage for treatment of Herpes simplex and prophylaxis of Herpes simplex infection in children: 2 years and over: adult dose; below 2 years: half the adult dose.
Dosage for treatment of Varicella infections in children: Over the age of six years: 800 mg ZEVIN four times daily for 5 days.
Between the age of two years and six years: 400 mg ZEVIN four times daily for 5 days.
Below the age of two years: 200 mg ZEVIN four times daily for 5 days.
Dosage in the elderly: In the elderly, total Acyclovir body clearance declines in parallel with creatinine clearance. Adequate hydration of elderly patients taking high oral doses of ZEVIN should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function.
Dosage in renal impairment: For the management of Herpes simplex infection: The recommended oral doses will not lead to accumulation of acyclovir.
However, for patients with severe renal impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200 mg twice daily, at approximately 12 hours intervals in recommended.
For the treatment of Varicella and Herpes zoster infections: It is recommended to adjust the dosage to 800 mg twice daily, at approximately 12 hours intervals for patients with severe renal impairments (creatinine clearance less than 10 ml/minute) and to 800 mg 3 times daily, at approximately 8 hours interval for patients with moderate renal impairment (creatinine clearance in the range 10 to 25 ml/minute).
Overdosage of acyclovir may cause renal dysfunction and eventual renal failure and anuria according to the precipitation of acyclovir crystals in the renal tubules.
If acute renal failure and anuria occur, dosage of the drug should be adjusted and hemodialysis considered until the renal function is restored.
ZEVIN is contraindicated in patients known to be hypersensitive to acyclovir.
Should avoid sexual contact while visible lesions are present because of the risk of infecting intimate partners.
Should be cautious not to exceed the prescribed dosage.
The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not pose a genetic risk to a man.
Acyclovir was not found to be carcinogenic in long term studies in the rat and the mouse. Largely reversible adverse effects on the spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of acyclovir greatly in excess of those employed therapeutically.
Acyclovir tablet have been shown to have no definite effect upon sperm count, morphology or motility in man.
Use in pregnancy: Limit data are available on the use of acyclovir in pregnancy.
Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard.
Use in lactation: Limited data indicate that acyclovir is distributed into milk following systemic administration. Caution therefore advised if ZEVIN is to be administered to a nursing woman.
Use in pregnancy: Limit data are available on the use of acyclovir in pregnancy.
Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard.
Use in lactation: Limited data indicate that acyclovir is distributed into milk following systemic administration. Caution therefore advised if ZEVIN is to be administered to a nursing woman.
Headache, nausea, vomiting and diarrhea are among the most common adverse effects of oral acyclovir, occuring more frequently in patients receiving the drug as chronic suppressive therapy, but occuring less frequently during short-term therapy.
Vertigo, dizziness, fatigue, insomnia, irritability and mental depression have occured rarely.
Skin rashes have been reported in a few patients receiving acyclovir the rashes have resolved on withdrawal of the drug. Other events reported rarely in patients receiving oral formulations of acyclovir include mild, transient rises in bilirubin and liver related enzymes, small increases in blood urea and creatinine, small decreases in haematological indices.
Concomitant administration of probenecid and acyclovir has reportedly increased the mean plasma half life and area under the plasma-concentration time curve (AUC) and decreased urinary excretion and renal clearance of acyclovir. This interaction may result from the competitive inhibition of renal secretion of acyclovir by probenecid.
Store at temperature not exceeding 30°C, protect from light and moisture.
Shelf-Life: The shelf life period is 3 years.
J05AB01 - aciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
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