Country: United States
Language: English
Source: NLM (National Library of Medicine)
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)
REMEDYREPACK INC.
VALACYCLOVIR HYDROCHLORIDE
VALACYCLOVIR 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALACYCLOVIR TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions, Central Nervous System Effects ( 5.3) 3/2010 INDICATIONS AND USAGE Valacyclovir tablets, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1) Cold Sores (Herpes Labialis) Genital Herpes o Treatment in immunocompetent patients (initial or recurrent episode) o Suppression in immunocompetent or HIV-infected patients o reduction of transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (Herpes Labialis) Chicke npox Limitations of Use ( 1.3) The efficacy and safety of Valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients. DOSAGE AND ADMINISTRATION ADULT DOSAGE ( 2.1) 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 500 mg once daily with ≤9 recurrences/yr 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 ( 2.2) 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 Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from 500 mg Valacyclovir tablets, USP. ( 2.3) DOSAGE FORMS AND STRENGTHS Tablets: 500 mg (unscored), 1 gram (partially scored) ( 3) CONTRAINDICATIONS Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the Read the complete document