Zostiva500 mg

Zostiva 500 mg is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).

Herpes simplex & Varicella-zoster virus infections

Zostiva 500 mg is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Zostiva 500 mg is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Zostiva 500 mg lessens the symptoms of infections and shortens the length of time of sickness. Zostiva 500 mg is used in the treatment and suppression of genital herpes, shingles and cold sores.

Adult Dosage: Cold Sores: 2 grams every 12 hours for 1 day Genital Herpes: Initial episode: 1 gram twice daily for 10 days Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients: 1 gram once daily Alternate dose in patients with < 9 recurrences/year: 500 mg once daily HIV-infected patients: 500 mg twice daily Reduction of transmission: 500 mg once daily Herpes Zoster: 1 gram 3 times daily for 7 days Pediatric Dosage: Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

Adult Dosage: Cold Sores: 2 grams every 12 hours for 1 day Genital Herpes: Initial episode: 1 gram twice daily for 10 days Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients: 1 gram once daily Alternate dose in patients with < 9 recurrences/year: 500 mg once daily HIV-infected patients: 500 mg twice daily Reduction of transmission: 500 mg once daily Herpes Zoster: 1 gram 3 times daily for 7 days Pediatric Dosage: Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

No dosage adjustment is recommended when Zostiva 500 mg is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Zostiva 500 mg is contraindicated in patients with a known hypersensitivity or intolerance to Zostiva 500 mg, acyclovir, or any component of the formulation.

The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).

Pregnancy category B. Zostiva 500 mg was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of Zostiva 500 mg in pregnant women. Nursing Mothers: Unchanged Zostiva 500 mg was not detected in maternal serum, breast milk, or infant urine. Zostiva 500 mg should be administered to a nursing mother with caution and only when indicated.

Dosage reduction is recommended when administering Zostiva 500 mg to patients with renal impairment. Similar caution should be exercised when administering Zostiva 500 mg to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of Zostiva 500 mg have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients

Store in cool & dry place, away from children.

Pediatric Use: Safety and effectiveness of Zostiva 500 mg in pre-pubertal pediatric patients have not been established. Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of Zostiva 500 mg due to a low body weight or disorders (renal, CNS etc.) associated with aging.

Herpes simplex & Varicella-zoster virus infections

Zostiva 500 mg is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Zostiva 500 mg is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Zostiva 500 mg lessens the symptoms of infections and shortens the length of time of sickness. Zostiva 500 mg is used in the treatment and suppression of genital herpes, shingles and cold sores.

Pregnancy category B. Zostiva 500 mg was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of Zostiva 500 mg in pregnant women. Nursing Mothers: Unchanged Zostiva 500 mg was not detected in maternal serum, breast milk, or infant urine. Zostiva 500 mg should be administered to a nursing mother with caution and only when indicated.

Pediatric Use: Safety and effectiveness of Zostiva 500 mg in pre-pubertal pediatric patients have not been established. Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of Zostiva 500 mg due to a low body weight or disorders (renal, CNS etc.) associated with aging.