Valarux1 gm

Valarux 1 gm 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

Valarux 1 gm is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valarux 1 gm is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valarux 1 gm lessens the symptoms of infections and shortens the length of time of sickness. Valarux 1 gm 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 Valarux 1 gm is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Valarux 1 gm is contraindicated in patients with a known hypersensitivity or intolerance to Valarux 1 gm, 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. Valarux 1 gm 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 Valarux 1 gm in pregnant women. Nursing Mothers: Unchanged Valarux 1 gm was not detected in maternal serum, breast milk, or infant urine. Valarux 1 gm should be administered to a nursing mother with caution and only when indicated.

Dosage reduction is recommended when administering Valarux 1 gm to patients with renal impairment. Similar caution should be exercised when administering Valarux 1 gm to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of Valarux 1 gm 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 Valarux 1 gm in pre-pubertal pediatric patients have not been established. Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of Valarux 1 gm due to a low body weight or disorders (renal, CNS etc.) associated with aging.

Herpes simplex & Varicella-zoster virus infections

Valarux 1 gm is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valarux 1 gm is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valarux 1 gm lessens the symptoms of infections and shortens the length of time of sickness. Valarux 1 gm is used in the treatment and suppression of genital herpes, shingles and cold sores.

Pregnancy category B. Valarux 1 gm 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 Valarux 1 gm in pregnant women. Nursing Mothers: Unchanged Valarux 1 gm was not detected in maternal serum, breast milk, or infant urine. Valarux 1 gm should be administered to a nursing mother with caution and only when indicated.

Pediatric Use: Safety and effectiveness of Valarux 1 gm in pre-pubertal pediatric patients have not been established. Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of Valarux 1 gm due to a low body weight or disorders (renal, CNS etc.) associated with aging.