VALACYCLOVIR- 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:

REMEDYREPACK 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 tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herp

Product summary:

Valacyclovir tablets, USP (blue colored, capsule-shaped, film-coated tablets) containing valacyclovir hydrochloride, USP (hydrous) equivalent to 500 mg valacyclovir and debossed with " RX 904 " on one side and plain on the other side. NDC 63304-904-03 Bottles of 10 NDC 63304-904-30 Bottles of 30 NDC 63304-904-90 Bottles of 90 NDC 63304-904-05 Bottles of 500 NDC 63304-904-77 Blister pack of 100 Valacyclovir tablets, USP (blue colored, capsule-shaped, film-coated tablets) containing valacyclovir hydrochloride, USP (hydrous) equivalent to 1 gram valacyclovir and debossed with "RX 905" on one side and partial scorebar on both sides. NDC 63304-905-03 Bottles of 10 NDC 63304-905-30 Bottles of 30 NDC 63304-905-90 Bottles of 90 NDC 63304-905-05 Bottles of 500 NDC 63304-905-77 Blister pack of 100 Storage: Store at 20° - 25° C (68° - 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
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALACYCLOVIR TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALACYCLOVIR
TABLETS, USP.
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 tablets, USP are a nucleoside analogue DNA polymerase
inhibitor indicated for: (1)
Adult Patients (1.1) (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) (1)
Cold Sores (Herpes Labialis)
Chicke npox
Limitations of Use (1.3) (1)
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.
DOSAGE AND ADMINISTRATION
ADULTDOSAGE (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 recurrences/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
PEDIATRICDOSAGE (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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg (unscored), 1 gram (partially scored) (3) (3)
CONTRAINDICATIONS
Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or
any compone