Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)
REMEDYREPACK INC.
VALACYCLOVIR HYDROCHLORIDE
VALACYCLOVIR 1 g
ORAL
PRESCRIPTION DRUG
Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle or ulcer) has not been established. Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established. Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond o
Valacyclovir Tablets, USP are available containing valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram of valacyclovir. The 500 mg tablets are white, film-coated, oval shaped tablets imprinted with M122 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4275-93 bottles of 30 tablets NDC 0378-4275-77 bottles of 90 tablets NDC 0378-4275-05 bottles of 500 tablets The 1 gram tablets are white, film-coated, oval shaped tablets with a partial break line on both sides. They are imprinted with M123 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4276-93 bottles of 30 tablets NDC 0378-4276-77 bottles of 90 tablets NDC 0378-4276-05 bottles of 500 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
Abbreviated New Drug Application
VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALACYCLOVIR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALACYCLOVIR. 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 are 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) Chicke npox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets 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 Alternate dose in patients with ≤ 9 recurrences/yr HIV-infected patients 1 gram once daily 500 mg once daily 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 valacylovir tablets ( 2.3). DOSAGE FORMS AND STRENGTHS Tablets: 500 mg (unscored), 1 gram (partial break line) ( 3) CONTRAINDICATIONS Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir or any component of the formulation. ( 4) Læs hele dokumentet