LAMIVUDINE AND ZIDOVUDINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Lupin Pharmaceuticals, Inc.

INN (International Nazwa):

LAMIVUDINE

Skład:

LAMIVUDINE 150 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Lamivudine and zidovudine tablet, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablet is 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 tablets 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 populati

Podsumowanie produktu:

Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are white to off white, scored, modified-capsule-shaped, film-coated tablets, debossed on both tablet faces, such that when broken in half, "LU" and "Y01" code is present on both halves of the tablet ("LU" on one face and "Y01" on the opposite face of the tablet). They are available as follows: Bottles of 60's                                          NDC 68180-284-07 Store between 2° and 30°C (36° and 86°F).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET
LUPIN 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 INCLUDING LAMIVUDINE AND
ZIDOVUDINE (COMPONENTS OF LAMIVUDINE
AND ZIDOVUDINE TABLET). 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 TABLETS. MONITOR HEPATIC
FUNCTION CLOSELY IN THESE PATIENTS AND,
IF APPROPRIATE, INITIATE ANTI-HEPATITIS B TREATMENT. (5.4)
INDICATIONS AND USAGE
Lamivudine and zidovudine tablet, a combination of 2 nucleoside
analogue reverse transcriptase inhibitors, is 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