País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)
NuCare 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 tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herp
Valacyclovir tablets, USP (blue colored, capsule-shaped, film-coated tablets) containing valacyclovir hydrochloride, USP (hydrous) equivalent to 1 gram valacyclovir and debossed with "RX 905" on one side and partial scorebar on both sides NDC 68071-3276-2 Bottles of 2 NDC 68071-3276-4 Bottles of 4
Abbreviated New Drug Application
VALACYCLOVIR- VALACYCLOVIR TABLET, FILM COATED NUCARE PHARMACEUTICALS, 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, FOR ORAL USE 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 are a nucleoside analogue DNA polymerase inhibitor indicated for: (1) Adult Patients (1.1) (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) (1) Cold Sores (Herpes Labialis) Chicke npox Limitations of Use (1.3) (1) 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 ADULTDOSAGE (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 recurrences/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 PEDIATRICDOSAGE (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. (2.3) (2) DOSAGE FORMS AND STRENGTHS Tablets: 500 mg (unscored), 1 gram (partially scored) (3) (3) CONTRAINDICATIONS Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or Leer el documento completo