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:

Mylan Institutional Inc.

INN (International Name):

VALACYCLOVIR HYDROCHLORIDE

Composition:

VALACYCLOVIR 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-1–infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyon

Product summary:

Valacyclovir Tablets, USP are available containing 556.2 mg of valacyclovir hydrochloride, USP (hydrous) equivalent to 500 mg of valacyclovir, respectively. The 500 mg tablets are white, film-coated, oval, unscored tablets with M122 imprinted with black ink on one side of the tablet and plain on the other side of the tablet. They are available as follows: NDC 51079-093-03 – Unit dose blister packages of 30 (5 cards of 6 tablets each). Storage: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE TABLET, FILM
COATED
MYLAN INSTITUTIONAL INC.
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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 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)
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-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 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)
WARNINGS