VALACYCLOVIR 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

VALACYCLOVIR HYDROCHLORIDE

Composition:

VALACYCLOVIR 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP 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, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir

Product summary:

Valacyclovir Tablets USP, 1 gm  are white to off-white, film-coated, capsule shaped tablets, debossed with 'I' on one side and '87' on other side with partial scorebar on both sides. They are supplied in Bottle of 6 (NDC 43063-771-06) Bottle of 14 (NDC 43063-771-14) Bottle of 20 (NDC 43063-771-20) Bottle of 21 (NDC 43063-771-21) Storage: Store at 20° to 25°C (68° to 77°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- VALACYCLOVIR TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INITIAL U.S. APPROVAL:1995
RECENT MAJOR CHANGES
Warnings and Precautions, Central Nervous System Effects (5.3) 3/2010
INDICATIONS AND USAGE
Valacyclovir tablet, USP 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, USP have not been
established in immunocompromised patients other than for the
suppression of genital herpes in HIV-
infected patients. (1)
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
≤9 recurrnces/yr
500 mg once daily
HIV-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 (≥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, USP. (2.3) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg (unscored), 1gm (partially scored) (3) (3)
CONTRAINDICATIONS
Hypersensitivity to va