Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
Lannett Company, Inc.
LAMIVUDINE
LAMIVUDINE 10 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Lamivudine oral solution, USP is 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 oral solution is 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 gene
Lamivudine Oral Solution, USP is a clear, colorless, strawberry flavored liquid. Each mL of the solution contains 10 mg of lamivudine. Packaged as follows: Plastic bottle of 240 mL (NDC 54838-566-70) with child-resistant closure. This product does not require reconstitution. Recommended Storage: Store in tightly closed bottles at 25°C (77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LAMIVUDINE- LAMIVUDINE SOLUTION LANNETT COMPANY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LAMIVUDINE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE ORAL SOLUTION. LAMIVUDINE ORAL SOLUTION, USP 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) INDICATIONS AND USAGE Lamivudine oral solution, USP is 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 must be adjusted in accordance with renal function. (2.3) DOSAGE FORMS AND STRENGTHS Oral Solution: 10 mg per mL (3) CONTRAINDICATIONS Lamivudine oral solution is contraindicated in patients with previous hypersensitivity reaction to lamivudine. (4) WARNINGS AND PRECAUTIONS Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. (5.1) Lactic acidosis and severe hepatomegaly with steatos Preberite celoten dokument