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:

Camber Pharmaceuticals, 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. 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. 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 general popu

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
CAMBER PHARMACEUTICALS, 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: 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-L) 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-L. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with Interferon-and
Ribavirin-Based Regimens (previous 5.3) Removed 05/2019
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 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
• Tablets:150 mg, scored (3)
• Tablets: 300 mg (3)
CONTRAINDICATIONS
Lamivudine tablets are contraindicated in patients with previous
hypersensitivity reaction to lamivudine. (4)
WARNINGS AND PRECAUTIONS
• Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant
HBV varian