VALGANCICLOVIR tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Cipla USA Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)] . Prevention of CMV Disease: Valganciclovir is 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 is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2)] . Valganciclovir is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions (6.1)]. Risk Summary After oral administration, valganciclovir (prodrug) is conver

Proizvod sažetak:

Valganciclovir tablets, USP, 450 mg are pink colored, capsule shaped, biconvex, film-coated tablets, debossed with 'C 277' on one side and 'plain' on other side. Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP equivalent to 450 mg of valganciclovir. Valganciclovir tablet is supplied in bottles of 60 tablets (NDC 69097-277-03). Store valganciclovir tablets at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

VALGANCICLOVIR - VALGANCICLOVIR TABLET
CIPLA USA INC.
----------
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._
HEMATOLOGIC TOXICITY: SEVERE LEUKOPENIA, NEUTROPENIA, ANEMIA,
THROMBOCYTOPENIA,
PANCYTOPENIA, AND BONE MARROW FAILURE INCLUDING APLASTIC ANEMIA HAVE
BEEN
REPORTED IN PATIENTS TREATED WITH VALGANCICLOVIR. (5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
VALGANCICLOVIR MAY CAUSE TEMPORARY OR PERMANENT INHIBITION OF
SPERMATOGENESIS IN
MALES AND SUPPRESSION OF FERTILITY IN FEMALES. (5.3)
FETAL TOXICITY: BASED ON ANIMAL DATA, VALGANCICLOVIR HAS THE POTENTIAL
TO CAUSE BIRTH
DEFECTS IN HUMANS. (5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, VALGANCICLOVIR
HAS THE
POTENTIAL TO CAUSE CANCERS IN HUMANS. (5.5)
INDICATIONS AND USAGE
Valganciclovir is a deoxynucleoside analogue cytomegalovirus (CMV) 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 kidney and 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 days post‑transplantation
Prevention of CMV disease in
kidney transplant patients
900 mg (two 450 mg tablet