LAMIVUDINE tablet film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

REMEDYREPACK INC.

INN (Միջազգային անվանումը):

LAMIVUDINE

Կազմը:

LAMIVUDINE 300 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

LAMIVUDINE- LAMIVUDINE TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE TABLETS.
LAMIVUDINE TABLETS
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF
HEPATITS
B, AND DIFFERENT FORMULATIONS OF LAMIVUDINE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGUES. SUSPEND TREATMENT IF CLINICAL OR
LABORATORY FINDINGS SUGGESTIVE OF LACTIC
ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCUR.(5.1)
• 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-L)AND
HAVE DISCONTINUED LAMIVUDINE.
MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI- HEPATITIS B TREATMENT.(
5.2)
• PATIENTS WITH HIV-1 INFECTION SHOULD RECEIVE ONLY DOSAGE FORMS OF
LAMIVUDINE APPROPRIATE FOR TREATMENT
OF HIV-L.( 5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 07/2016
Warnings and Precautions, Patients with Hepatitis B Virus Co-infection
(5.2) 09/2015
Warnings and Precautions, Related Products that are Removed-Not
Recommended (5.3) 07/2016
Warnings and Precautions, Lower Virologic Suppression 07/2016
Rates and Increased Risk of Viral Resistance with Oral
Solution (5.6)
INDICATIONS AND USAGE
Lamivudine tablet is a nucleoside analogue reverse transcriptase
inhibitor indicated in combination with other antiretroviral
agents for the treatment of HIV-1 infection.
Limitation of Use: The dosage of this product is for HIV-1 and not for
HBV. ( 1)
DOSAGE AND ADMINISTRATION
• Adults: 300 mg daily, administered as either 150 mg twice daily or
300 mg once daily. ( 2.1)
• Pediatric Patients Aged 3 Months and Older: Administered twice
daily. D