VALGANCICLOVIR hydrochloride tablet film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

VALGANCICLOVIR HYDROCHLORIDE (UNII: 4P3T9QF9NZ) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Saatavilla:

Golden State Medical Supply Inc.

INN (Kansainvälinen yleisnimi):

VALGANCICLOVIR HYDROCHLORIDE

Koostumus:

VALGANCICLOVIR 450 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

VALGANCICLOVIR- VALGANCICLOVIR HYDROCHLORIDE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALGANCICLOVIR TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALGANCICLOVIR
TABLETS.
VALGANCICLOVIR TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Indications and Usage, Pediatric Patients (1.2) 04/2015
Dosage and Administration, Pediatric Patients (2.3) 04/2015
INDICATIONS AND USAGE
Valganciclovir Tablets, USP are a cytomegalovirus (CMV) nucleoside
analogue DNA polymerase inhibitor indicated for:
Adult Patients (1.1)
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Pediatric Patients (1.2)
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DOSAGE AND ADMINISTRATION
ADULT DOSAGE (2.2)
Treatment of CMV retinitis
Induction: 900 mg (two 450 mg tablets) twice a day for 21 days
Maintenance: 900 mg (two 450 mg tablets) once a day
Prevention of CMV disease in heart
or kidney-pancreas transplant
patie nts
900 mg (two 450 mg tablets) once a day within 10 days of
transplantation until 100
days post-transplantation
Prevention of CMV disease in
kidney transplant patients
900 mg (two 450 mg tablets) once a day within 10 days of
transplantation until 200
days post-transplantation
PEDIATRIC DOSAGE (2.3)
Prevention of CMV disease in heart
transplant patients 4 months to 16
years of age
Dose once a day within 10 days of transplantation until 100 days
post-transplantation
according to dosage algorithm (note the calculation of creatinine
clearance using a
modified Schwartz formula in children)
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HEMATOLOGIC TOXICITY: SEVERE LEUKOPENIA, NEUTROPENIA, ANEMIA,
THROMBOCYTOPENIA, PANCYTOPENIA,
BONE MARROW APLASIA AND APLASTIC ANEMIA HAVE BEEN REPORTED IN PATIENTS
TREATED WITH VALGANCICLOVIR
(5.1).
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA, VALGANCICLOVIR MAY
CAUSE TEMPORAR