LAMIVUDINE- lamivudine tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. Available data from the Antiretroviral Pregnancy Registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposures as the recommended clinical

Tóm tắt sản phẩm:

Lamivudine Tablets, USP are available containing 150 mg or 300 mg of lamivudine, USP. The 150 mg tablets are white to off-white, film-coated, capsule shaped, functionally scored tablets debossed with M on the left of the score and 2 on the right of the score on one side of the tablet and L on the left of the score and N on the right of the score on the other side. They are available as follows: NDC 0378-5169-91 bottles of 60 tablets The 300 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and LN3 on the other side. They are available as follows: NDC 0378-5170-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LAMIVUDINE- LAMIVUDINE TABLET, FILM COATED
REMEDYREPACK INC.
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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: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF
HEPATITIS B,
AND DIFFERENT FORMULATIONS OF LAMIVUDINE
_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. ( 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. 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 APPROPRIATE FOR
TREATMENT OF HIV-1. ( 5.2)
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2) 07/2016
Warnings and Precautions, Patients with Hepatitis B Virus Co-infection
( 5.2) 09/2015
Warnings and Precautions, Related Products that are Not Recommended (
5.3) Removed - 07/2016
Warnings and Precautions, Lower Virologic Suppression Rates and
Increased Risk of Viral Resistance with Oral Solution (
5.6) 07/2016
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 twice daily.
Dose should be calculated on body weight (kg)
and should not exceed 300 mg daily. ( 2.2)
Patients with Renal Im