VALGANCICLOVIR HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

VALGANCICLOVIR HYDROCHLORIDE

Composition:

VALGANCICLOVIR 450 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Treatment of Cytomegalovirus (CMV) Retinitis:   Valganciclovir tablets 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 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 are 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 tablets are 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

Product summary:

Valganciclovir Tablets USP, 450 mg are pink colored, oval shaped, biconvex, film-coated tablets, debossed with ‘H’ on one side and ‘96’ on other side. Bottles of 60                              NDC 65862-753-60 Bottles of 100                            NDC 65862-753-01 Bottles of 180                            NDC 65862-753-18 Bottles of 500                            NDC 65862-753-05 Bottles of 1,000                         NDC 65862-753-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALGANCICLOVIR HYDROCHLORIDE - VALGANCICLOVIR HYDROCHLORIDE TABLET
AUROBINDO PHARMA LIMITED
----------
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 HYDROCHLORIDE. (5.1)
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
VALGANCICLOVIR HYDROCHLORIDE 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 HYDROCHLORIDE HAS
THE POTENTIAL
TO CAUSE BIRTH DEFECTS IN HUMANS. (5.4)
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, VALGANCICLOVIR
HYDROCHLORIDE HAS THE POTENTIAL TO CAUSE CANCERS IN HUMANS. (5.5)
INDICATIONS AND USAGE
Valganciclovir tablets are 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 po