Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)
PD-Rx Pharmaceuticals, Inc.
VALACYCLOVIR HYDROCHLORIDE
VALACYCLOVIR 1 g
ORAL
PRESCRIPTION DRUG
Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir
Valacyclovir Tablets USP, 1 gm are white to off-white, film-coated, capsule shaped tablets, debossed with 'I' on one side and '87' on other side with partial scorebar on both sides. They are supplied in Bottle of 6 (NDC 43063-771-06) Bottle of 14 (NDC 43063-771-14) Bottle of 20 (NDC 43063-771-20) Bottle of 21 (NDC 43063-771-21) Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.
Abbreviated New Drug Application
VALACYCLOVIR- VALACYCLOVIR TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALACYCLOVIR HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALACYCLOVIR HYDROCHLORIDE. 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 tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) • 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 Pediatric Patients (1.2) • Cold Sores (Herpes Labialis) • Chickenpox 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. (1) 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 with ≤9 recurrnces/yr 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 (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 the 500 mg valacyclovir tablets, USP. (2.3) (2) DOSAGE FORMS AND STRENGTHS Tablets: 500 mg (unscored), 1gm (partially scored) (3) (3) CONTRAINDICATIONS Hypersensitivity to va Preberite celoten dokument