VALACYCLOVIR HYDROCHLORIDE- valacyclovir hydrochloride tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

INN (International Name):

VALACYCLOVIR HYDROCHLORIDE

구성:

VALACYCLOVIR 1 g

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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-infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond o

제품 요약:

Valacyclovir Tablets, USP are available containing valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram of valacyclovir. The 500 mg tablets are white, film-coated, oval shaped tablets imprinted with M122 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4275-93 bottles of 30 tablets NDC 0378-4275-77 bottles of 90 tablets NDC 0378-4275-05 bottles of 500 tablets The 1 gram tablets are white, film-coated, oval shaped tablets with a partial break line on both sides. They are imprinted with M123 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4276-93 bottles of 30 tablets NDC 0378-4276-77 bottles of 90 tablets NDC 0378-4276-05 bottles of 500 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

VALACYCLOVIR HYDROCHLORIDE- VALACYCLOVIR HYDROCHLORIDE 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 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALACYCLOVIR.
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 are 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)
Chicke npox
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-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 ≤ 9
recurrences/yr
HIV-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 (≥ 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 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)