LAMIVUDINE- lamivudine tablet, film coated

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 Tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-l) infection.   Limitation of use: The dosage of this product is for HIV-1and not for HBV. Lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Teratogenic Effects 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

Product summary:

Lamivudine Scored Tablets, 150 mg White capsule shaped, biconvex, scored film coated tablets debossed with "J" on one side and "16" on the other side, 1 and 6 seperated by a score line. Bottle of 60 tablets NDC 31722-753-60 Bottle of 600 tablets NDC 31722-753-06 Blister Card of 10 Unit-dose tablets NDC 31722-753-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-753-32 Lamivudine Tablets, 300 mg White capsule shaped, biconvex, film coated tablets debossed with "17" on one side and "J" on the other side. Bottle of 30 tablets NDC 31722-754-30 Bottle of 600 tablets NDC 31722-754-06 Blister Card of 10 Unit-dose tablets NDC 31722-754-31 Blister pack of 100 (10 x 10) Unit-dose tablets NDC 31722-754-32 Recommended Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF
HEPATITS
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. 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-L)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-L.( 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 Removed-Not
Recommended (5.3) 07/2016
Warnings and Precautions, Lower Virologic Suppression 07/2016
Rates and Increased Risk of Viral Resistance with Oral
Solution (5.6)
INDICATIONS AND USAGE
Lamivudine tablet 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. D