LAMIVUDINE AND ZIDOVUDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

Available from:

American Health Packaging

INN (International Name):

LAMIVUDINE

Composition:

LAMIVUDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lamivudine and Zidovudine tablets, a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and Zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine 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 or zidovudine 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 p

Product summary:

Lamivudine and Zidovudine Tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white, modified capsule shaped, biconvex, film-coated tablets with deep breakline in between ‘J’ and ‘58’ on one side and deep breakline on the other side. They are available as follows: Unit dose packages of 30 (5 x 6) NDC 68084-416-25 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET, FILM
COATED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE AND
ZIDOVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LAMIVUDINE AND ZIDOVUDINE TABLETS.
LAMIVUDINE AND ZIDOVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY WITH STEATOSIS, AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN
ASSOCIATED WITH
THE USE OF ZIDOVUDINE, A COMPONENT OF LAMIVUDINE AND ZIDOVUDINE. (5.1)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.2)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE
BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES INCLUDING
LAMIVUDINE AND
ZIDOVUDINE. SUSPEND TREATMENT IF CLINICAL OR LABORATORY FINDINGS
SUGGESTIVE OF LACTIC
ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCUR. (5.3)
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, A COMPONENT OF LAMIVUDINE AND
ZIDOVUDINE.
MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-
HEPATITIS B TREATMENT. (5.4)
INDICATIONS AND USAGE
Lamivudine and Zidovudine tablets, a combination of 2 nucleoside
analogue reverse transcriptase
inhibitors, are indicated in combination with other antiretroviral
agents for the treatment of HIV-1 infection.
(1)
DOSAGE AND ADMINISTRATION
Adults and Adolescents weighing greater than or equal to 30 kg: 1
tablet orally twice daily. (2.1)
Pediatrics weighing greater than or equal to 30 kg: 1 tablet orally
twice daily. (2.2)
Because lamivudine and zidovudine is a fixed-dose tablet and cannot be
dose adjusted, lamivudine and
zidovudine t