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:

Preferred Pharmaceuticals Inc.

INN (International Nazwa):

LAMIVUDINE

Skład:

LAMIVUDINE 150 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Lamivudine and zidovudine tablets, USP 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, USP 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 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 g

Podsumowanie produktu:

Lamivudine and zidovudine tablets, USP [150/300 mg], containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white colored, oval, film coated tablets with "LZ" engraved on one side and breakline on other side. They are available as follows: 60 Tablets/Bottle (NDC 64380-707-03) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET
PREFERRED 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, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LAMIVUDINE AND ZIDOVUDINE TABLETS, USP [150/300
MG ]
LAMIVUDINE AND ZIDOVUDINE TABLETS, USP [150/300 MG] 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, HAVE 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 TABLETS). SUSPEND TREATMENT IF CLINICAL OR LABORATORY
FINDINGS SUGGESTIVE OF LACTIC ACIDOSIS OR
PRONOUNCED HEPATOTOXICITY OCCURS. (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 tablets, USP 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
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: Scored 150 mg lamivudine and 300 mg zidovudine (3)
CONTRAINDICATIONS
Lamivudine and zidovudine tablets, USP are contraindicated i