VALACYCLOVIR HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Valacyclovir Hydrochloride (UNII: G447S0T1VC) (Acyclovir - UNII:X4HES1O11F)

Available from:

Dr. Reddys Laboratories Limited

INN (International Name):

valacyclovir

Composition:

valacyclovir 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cold Sores (Herpes Labialis): Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride 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: Valacyclovirtablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovirtablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride 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 immunocompete

Product summary:

Valacyclovir tablets USP, 500 mg are blue colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘552’ on the other side and are supplied in bottles of 30, 42, 90, 500 and unit dose packages of 100 (10x10). Bottles of 30                                                                           NDC 55111-552-30 Bottles of 42                                                                           NDC 55111-552-42 Bottles of 90                                                                           NDC 55111-552-90 Bottles of 500                                                                         NDC 55111-552-05 Unit dose packages of 100 (10x10)                                        NDC 55111-552-78  Valacyclovir tablets USP, 1 gram are blue colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ with partially scored on one side and ‘553’ with partially scored on other side and are supplied in bottles of 30, 90, 100, 500 and unit dose packages of 100 (10x10).  Bottles of 30                                                                           NDC 55111-553-30 Bottles of 90                                                                           NDC 55111-553-90 Bottles of 100                                                                         NDC 55111-553-01 Bottles of 500                                                                         NDC 55111-553-05 Unit dose packages of 100 (10x10)                                        NDC 55111-553-78  Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET, FILM
COATED
DR. REDDYS LABORATORIES LIMITED
----------
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 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 hydrochloride is a nucleoside analogue DNA
polymeraseinhibitor 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 hydrochloride 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
Immuno competent 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 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
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 formulation. (4)
WARNINGS AND PRECAUTIONS
Thrombotic thrombocytopenic purpura/hemoly