LAMIVUDINE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Verfügbar ab:

Aurobindo Pharma Limited

INN (Internationale Bezeichnung):

LAMIVUDINE

Zusammensetzung:

LAMIVUDINE 150 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: - The dosage of this product is for HIV-1 and not for HBV. Lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. Th

Produktbesonderheiten:

Lamivudine Tablets USP, 150 mg (Scored)  are white to off-white, film-coated, oval shaped tablets, debossed with ‘66’ and ‘Y’ on either side of the score line on one side and plain with a score line on the other side.                   Bottle of 60 Tablets                                      NDC 65862-552-60                   Carton of 60 (6 x 10) Unit-dose Tablets       NDC 65862-552-10 Lamivudine Tablets USP, 300 mg  are white to off-white, film-coated, oval shaped tablets, debossed with ‘67 Y’ on one side and plain on the other side.                   Bottle of 30 Tablets                                        NDC 65862-553-30                   Carton of 30 (3 x 10) Unit-dose Tablets         NDC 65862-553-10 Recommended Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

LAMIVUDINE - LAMIVUDINE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE TABLETS.
LAMIVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: EXACERBATIONS OF HEPATITIS B, AND DIFFERENT FORMULATIONS OF
LAMIVUDINE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED_ _WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE CO-INFECTED WITH
HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) AND
HAVE DISCONTINUED
LAMIVUDINE. MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-
HEPATITIS B TREATMENT. (5.1)
PATIENTS WITH HIV-1 INFECTION SHOULD RECEIVE ONLY DOSAGE FORMS OF
LAMIVUDINE APPROPRIATE FOR
TREATMENT OF HIV-1. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with Interferon- and Removed
Ribavirin-Based Regimens (previous 5.3) 05/2019
INDICATIONS AND USAGE
Lamivudine tablets are a nucleoside analogue reverse transcriptase
inhibitor indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection.
Limitations of Use: The dosage of this product is for HIV-1 and
not for HBV. (1)
DOSAGE AND ADMINISTRATION
• Adults: 300 mg daily, administered as either 150 mg twice daily or
300 mg once daily. (2.1)
• Pediatric Patients Aged 3 Months and Older: Administered either
once or twice daily. Dose should be calculated on body
weight (kg) and should not exceed 300 mg daily. (2.2)
• Patients with Renal Impairment: Doses of lamivudine tablets must
be adjusted in accordance with renal function. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, scored (3)
Tablets: 300 mg (3)
CONTRAINDICATIONS
Lamivudine tablets are contraindicated in patients with previous
hypersensitivity reaction to lamivudine. (4)
WARNINGS AND PRECAUTIONS
Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV
var