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:

Major Pharmaceuticals

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 genital herpes in

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 containing 556 mg of valacyclovir hydrochloride equivalent to 500 mg of valacyclovir. Carton of 30 tablets (6 tablets each blister pack x 5) NDC 0904-6565-07             Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6565-61 Store at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET, FILM
COATED
MAJOR PHARMACEUTICALS
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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 hydrochloride is a deoxynucleoside analogue DNA
polymerase inhibitor indicated for:
Adult Patients (1.1)
•
•
•
Pediatric Patients (1.2)
•
•
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
Alternate dose in patients with less than or
equal to 9 recurrences/year
HIV‑1-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 (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 the 500 mg valacyclovir
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
any component of the formulation. (4)
WARNINGS AND PRECAUTIONS
•
•
Cold Sores (Herpes Labialis)
Genital Herpes
•
•
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Treatment in immunocompetent patients (initial or recurrent episode)
Suppression in immunocompetent or HIV-1-infected patients
Reduction of transmission
Her