VALGANCICLOVIR tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

McKesson Corporation DBA SKY Packaging

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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, gan

Povzetek izdelek:

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: Boxes of 3 x 10 UD 30 NDC 63739-076-33 Store at 25 o C; excursions permitted between 15 o and 30 o C (59 o and 86 o F). [See USP Controlled Room Temperature.]

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

VALGANCICLOVIR- VALGANCICLOVIR TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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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)
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 with