LAMIVUDINE AND ZIDOVUDINE tablet film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Dostupné s:

St Marys Medical Park Pharmacy

INN (Mezinárodní Name):

LAMIVUDINE

Složení:

LAMIVUDINE 150 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LAMIVUDINE AND ZIDOVUDINE - LAMIVUDINE AND ZIDOVUDINE TABLET, FILM
COATED
ST MARYS MEDICAL PARK PHARMACY
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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.
LAMIVUDINE AND ZIDOVUDINE TABLETS, USP 150 MG/300 MG FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: RISK OF HEMATOLOGIC TOXICITY, MYOPATHY,
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND ANEMIA HAVE BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE, ONE OF THE COMPONENTS OF LAMIVUDINE AND ZIDOVUDINE
TABLETS. (5.1)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.2)
LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL
CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE ANALOGUES INCLUDING 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 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, a combination of two 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 ≥ 30 kg: 1 tablet twice daily. (2.1)
Pediatrics: Dosage should be based on body weight not to exceed adult
doses. (2.2)
Lamivudine and zidovudine tablets USP, a fixed-dose product, should
not be prescribed for pediatric patients weighing less
than 30 kg or patients requiring dosage adjustment, such as those