VALGANCICLOVIR- valganciclovir hydrochloride tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

AvKARE

INN (الاسم الدولي):

VALGANCICLOVIR HYDROCHLORIDE

تركيب:

VALGANCICLOVIR 450 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Treatment of Cytomegalovirus (CMV) Retinitis:  Valganciclovir Tablets, USP are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . Prevention of CMV Disease: Valganciclovir Tablets, USP are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)] . Prevention of CMV Disease: Valganciclovir Tablets, USP are indicated for the prevention of CMV disease in heart transplant patients (4 months to 16 years of age) at high risk [see Clinical Studies (14.2)] . Pediatric use information for pediatric kidney transplant patients ages 4 months to 16 years and for pediatric heart transplant patients ages 1 to less than 4 months is approved for Ro

ملخص المنتج:

Valganciclovir Tablets, USP: Supplied as 450 mg, pink, convex oval tablets with "E114" on one side and plain on the other side. Each film-coated tablet contains 450 mg of valganciclovir as valganciclovir hydrochloride. Valganciclovir Tablets, USP, is supplied in bottles of 60 tablets (NDC 42291-875-60). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature] .

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

VALGANCICLOVIR- VALGANCICLOVIR HYDROCHLORIDE TABLET, FILM COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VALGANCICLOVIR TABLETS, USP
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._
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 TEMPORARY
OR PERMANENT INHIBITION OF SPERMATOGENESIS ( 5.2).
FETAL TOXICITY: BASED ON ANIMAL DATA, VALGANCICLOVIR HAS THE POTENTIAL
TO CAUSE BIRTH
DEFECTS IN HUMANS ( 5.3).
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, VALGANCICLOVIR
HAS THE
POTENTIAL TO CAUSE CANCERS IN HUMANS ( 5.4).
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)
Treatment of CMV retinitis in patients with acquired immunodeficiency
syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas
transplant patients at high risk.
Pediatric Patients ( 1.2)
Prevention of CMV disease in heart transplant patients at high risk.
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 patients
900 mg (two 450 mg tablets) once a day within 10 days of
transplantation
until 100 da