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:

AvPAK

INN (International Name):

VALACYCLOVIR HYDROCHLORIDE

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 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 g

Product summary:

Valacyclovir Tablets USP, 500 mg are blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside. NDC 50268-788-15 10 Tablets per card, 5 cards per carton Valacyclovir Tablets USP, 1 gram are blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside. NDC 50268-789-15 (10 Tablets per card, 5 cards per carton) Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature.] Dispensed in Blister Punch Material. For Institutional Use Only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET, FILM
COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VALACYCLOVIR TABLETS, USP
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
RECENT MAJOR CHANGES
Warnings and Precautions, Central Nervous System Effects (5.3)
3/2010
INDICATIONS AND USAGE
Valacyclovir hydrochloride 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 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 valacyclovir
tablets. (2.3)
tablets. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg (unscored), 1 gram (partially scored) (3)
CONTRAINDICATIONS
Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or