LAMIVUDINE AND ZIDOVUDINE- lamivudine and zidovudine tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nama Antarabangsa):

LAMIVUDINE

Komposisi:

LAMIVUDINE 150 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 Category C Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. Fetal Risk Summary There are no adequate and well-controlled trials of lamivudine and zidovudine in pregnant women. Clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of HIV-1 infection to the fetus. Animal reproduction studies performed with lamivudine and zidovudine showed increased embryot

Ringkasan produk:

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: Bottles of 60                           NDC 65862-597-60 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET, FILM
COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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, AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEMATOLOGIC TOXICITY
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE, A COMPONENT OF LAMIVUDINE AND ZIDOVUDINE. (5.1)
MYO PATHY
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.2)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGUES. (5.3)
EXACERBATIONS OF HEPATITIS B
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5) 09/2015
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, lam