VALACYCLOVIR tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)

Tillgänglig från:

Teva Pharmaceuticals USA, Inc.

INN (International namn):

VALACYCLOVIR HYDROCHLORIDE

Sammansättning:

VALACYCLOVIR 500 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Cold Sores (Herpes Labialis) 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. Genital Herpes Initial Episode: 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. Recurrent Episodes: 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. Suppressive Therapy: Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1−inf

Produktsammanfattning:

Valacyclovir tablets USP are available as follows: 1 gram: blue, film-coated, capsule-shaped tablets, partially scored on both sides and debossed with "93" on one side and "7259" on the other. Available in bottles of 30 (NDC 0093-7259-56) and 90 (NDC 0093-7259-98). Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

VALACYCLOVIR- VALACYCLOVIR TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALACYCLOVIR TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALACYCLOVIR
TABLETS.
VALACYCLOVIR TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Valacyclovir tablets are a deoxynucleoside 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-1−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-1−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 with
less than or equal to 9 recurrences/year
500 mg once daily
HIV-1−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 (aged greater than or equal to
12 years)
2 grams every 12 hours for 1 day
Chickenpox (aged 2 to less than 18
years)
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 valacyclovir tablets, 500 mg. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 gram (partially scored) (3)
CONTRAINDICATIONS
Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or
any component of the formulation. (4)
WARNINGS AND PRECAUTIONS
Thrombotic thrombocytopenic purpu