LAMIVUDINE AND ZIDOVUDINE- lamivudine and zidovudine tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

PD-Rx Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

LAMIVUDINE

Samenstelling:

LAMIVUDINE 150 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 population.

Product samenvatting:

Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine, USP and 300 mg zidovudine, USP are available as white to off-white, film-coated, convex, modified oval shaped tablet, scored and debossed on both tablet sides, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 6 (NDC 43063-346-06). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET, FILM
COATED
PD-RX PHARMACEUTICALS, INC.
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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 TABLETS. ( 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. ( 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 TABLETS. MONITOR
HEPATIC FUNCTION CLOSELY IN
THESE PATIENTS AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS B
TREATMENT. ( 5.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Related Products that are Not Recommended
(previous 5.5) Removed - 02/2017
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 tablets are a fixed-dose tablet and
cannot be dose adjusted, lamivudine and
zidovudine t