Presentation

Valovir 500 Tablet: Each tablet contains Valacyclovir Hydrochloride INN equivalent to Valacyclovir 500 mg.

Valovir 1 gm Tablet: Each tablet contains Valacyclovir Hydrochloride INN equivalent to Valacyclovir 1 gm.

Description

Valacyclovir Hydrochloride is a nucleoside analogue DNA polymerase inhibitor. It is rapidly converted to Acyclovir which has demonstrated antiviral activity against HSV types 1 (HSV-1) and 2 (HSV-2) and VZV. Viral enzyme converts acyclovir to Acyclovir triphosphate which inhibits viral DNA synthesis.

Indications

Adult Patients:

– Cold Sores (Herpes Labialis)

– Genital Herpes

– Treatment in immunocompetent patients (initial or recurrent episode)

– Suppression in immunocompetent or HIV-infected patients

– Reduction of transmission

– Herpes Zoster

Paediatric Patients:

– Cold Sores (Herpes Labialis)

– Chickenpox

Dosage & Administration

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/y : 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

Side Effects

The most common adverse reactions reported in at least one indication by >10% of adult patients treated with valacyclovir hydrochloride and more commonly than in patients treated with placebo are headache, nausea, and abdominal pain.

The only adverse reaction occurring in >10% of paediatric patients <18 years of age was headache.

Precautions

Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients (over 65 years), and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno-compromised patients other than for the suppression of genital herpes in HIV-infected patients.

Use in Pregnancy & Lactation

Pregnancy Category B. Valacyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Caution should be exercised when Valacyclovir is administered to a lactating woman.

Drug Interaction

No clinically significant drug-drug or drug-food interactions with valacyclovir are known.

Over Dose

Caution should be exercised to prevent inadvertent overdose.

Commercial Pack

Valovir 500 tablet: Each box contains 1 blister strip of 10 tablets.

Valovir 1 gm tablet: Each box contains 4 blister strips