VALGANCICLOVIR tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Major Pharmaceuticals

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 administr

Περίληψη προϊόντος:

Valganciclovir tablets USP, 450 mg are pink, oval, biconvex, film-coated tablets, debossed with 'J' on one side and '156' on the other side. Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride, USP equivalent to 450 mg of valganciclovir. Valganciclovir tablets are supplied in: Carton of 20 tablets (10 tablets each blister pack x 2), NDC 0904-6796-10 Carton of 30 tablets (10 tablets each blister pack x 3), NDC 0904-6796-04 Store at 25o C; excursions permitted between 15o and 30o C (59o and 86o F). [See USP Controlled Room Temperature.]

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

VALGANCICLOVIR- VALGANCICLOVIR TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
TABLETS (5.1).
• IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN
DATE, VALGANCICLOVIR TABLETS 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 TABLETS HAVE
THE POTENTIAL TO CAUSE BIRTH DEFECTS IN
HUMANS. (5.4)
• MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA,
VALGANCICLOVIR TABLETS HAVE THE POTENTIAL TO
CAUSE CANCERS IN HUMANS. (5.5)
RECENT MAJOR CHANGES
Boxed Warning 08/2018
Warnings and Precautions (5.3) 08/2018
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
trans