LAMIVUDINE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

State of Florida DOH Central Pharmacy

INN (International ime):

LAMIVUDINE

Sastav:

LAMIVUDINE 150 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV. Lamivudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis) to any of the components of the products. Pregnancy Category C There are no adequate and well-controlled studies of lamivudine tablets in pregnant women. Animal reproduction studies in rats and rabbits revealed no evidence of teratogenicity. Increased early embryolethality occurred in rabbits at exposure levels similar to those in humans. Lamivudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in South Africa. The study assessed pharmacokinetics in: 16 women at 36 week

Proizvod sažetak:

Lamivudine tablets, 150 mg are white to off-white, diamond shaped, biconvex film-coated tablets, engraved “APO” on one side, “LMV” score “150” on the other side. Lamivudine tablets, 300 mg are grey, diamond shaped, biconvex film-coated tablets, engraved “APO” on one side, “LMV 300” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Recommended Storage Store lamivudine tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LAMIVUDINE - LAMIVUDINE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 150 MG AND 300 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS, POSTTREATMENT EXACERBATIONS OF HEPATITIS B
IN CO-
INFECTED PATIENTS, DIFFERENT FORMULATIONS OF LAMIVUDINE TABLETS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGUES. SUSPEND TREATMENT IF CLINICAL OR
LABORATORY FINDINGS SUGGESTIVE OF
LACTIC ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCUR. (5.1)
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
TABLETS. MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-HEPATITIS B
TREATMENT. (5.2)
PATIENTS WITH HIV-1 INFECTION SHOULD RECEIVE ONLY DOSAGE FORMS OF
LAMIVUDINE TABLETS APPROPRIATE FOR
TREATMENT OF HIV-1. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Immune Reconstitution Syndrome (5.6)
(11/2011)
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. Limitation
of Use: The dosage of this product is for HIV-1 and not
for HBV. (1)
DOSAGE AND ADMINISTRATION
Adults and adolescents >16 years of age: 300 mg daily, administered as
either 150 mg twice daily or 300 mg once daily.
(2.1)
Pediatric patients 3 months up to 16 years of age: Dosage should be
based on body weight. (2.2)
Patients With Renal Impairment: Doses of lamivudine tablets must be
adjusted in accordance with renal function. (2.3)
DOSAGE FORMS AND STRENGTHS
T