LAMIVUDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

LAMIVUDINE

Composition:

LAMIVUDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LAMIVUDINE 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 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. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. Risk Summary 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 US reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposur

Product summary:

LAMIVUDINE Scored Tablets, 150 mg White to off-white, film-coated tablets debossed with “MCR” and “313” separated by functional score on one side and plain on other side with functional score. Bottle of 60 tablets (NDC 50742-623-60) with child-resistant closure. LAMIVUDINE Tablets, 300 mg Gray, modified diamond-shaped, film-coated tablets engraved with “MCR" and "314” on one side and plain on the reverse side. Bottle of 30 tablets (NDC 50742-624-30) with child-resistant closure. Recommended Storage: Store LAMIVUDINE Tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LAMIVUDINE- LAMIVUDINE TABLET
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, Related Products that are Recommended (5.3)
Removed-Not
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 is 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: 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 Impairment: Doses of LAMIVUDINE must be adjusted
in accordance with renal function. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablet