VALACYCLOVIR tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F)

Pieejams no:

West-Ward Pharmaceuticals Corp.

SNN (starptautisko nepatentēto nosaukumu):

VALACYCLOVIR HYDROCHLORIDE

Kompozīcija:

VALACYCLOVIR 500 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

VALACYCLOVIR- VALACYCLOVIR TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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 ADMINISTRATION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Valacyclovir is a nucleoside analogue DNA polymerase inhibitor
indicated for:
Adult Patients (1.1)
•
•
Pediatric Patients (1.2)
•
Limitations of Use (1.3)
•
DOSAGE AND ADMINISTRATION
ADULT DOSAGE (2.1) (2)
Cold Sores (2)
2 grams every 12 hours for 1 day (2)
Genital Herpes (2)
Initial episode (2)
1 gram twice daily for 10 days (2)
Recurrent episodes (2)
500 mg twice daily for 3 days (2)
Suppressive therapy (2)
Immunocompetent patients (2)
1 gram once daily (2)
Alternate dose in patients with ≤9 (2)
recurrences/yr (2)
500 mg once daily (2)
HIV-infected patients (2)
500 mg twice daily (2)
Reduction of transmission (2)
500 mg once daily (2)
Herpes Zoster (2)
1 gram 3 times daily for 7 days (2)
PEDIATRIC DOSAGE (2.2) (2)
Cold Sores (≥12 years of age) (2)
2 grams every 12 hours for 1 day (2)
Labeling describing use of valacyclovir in pediatric patients with
chickenpox (ages 2 to ≤ 18 years) is approved for
GlaxoSmithKline’s Valtrex® Caplets. However, due to
GlaxoSmithKline’s marketing exclusivity rights, a description of
that pediatric use is not approved for this valacyclovir tablet
product. (2)
DOSAGE FORMS AND STRENGTHS
T able ts:
500 mg (unscored), 1 gram (partially scored) (3)
CONTRAINDICATIONS
Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or
any component of the formulation. (4)
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
Cold Sores (Herpes Labialis)
The efficacy and safety of valacyclovir has not been established in
immunoc