Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
State of Florida DOH Central Pharmacy
LAMIVUDINE
LAMIVUDINE 150 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
LAMIVUDINE - LAMIVUDINE TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- 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 Läs hela dokumentet