VALGANCICLOVIR tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

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 is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component o

Product summary:

Valganciclovir Tablets USP, 450 mg are pink colored, oval shaped, film coated tablets debossed with ‘RDY’ on one side and ‘762’ on other side, and are supplied in: Unit dose package of 30 (5 x 6) NDC 68084-965-25. Store at 20°C-25°C (68°F-77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VALGANCICLOVIR- VALGANCICLOVIR TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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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_.
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 tablet 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
patient