LAMIVUDINE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Camber Pharmaceuticals, Inc.

Designación común internacional (DCI):

LAMIVUDINE

Composición:

LAMIVUDINE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lamivudine tablets (HBV) are indi cat ed for the t r e atm ent of ch ronic h ep atitis B vi rus ( H B V) in f ection asso ci at ed with evid e n ce of h ep atitis B vi ral r epli c ation and active liv er in f l amm ation [s ee Clini cal Studi es (14.1, 14.2 ) ] . The follo wing points sh ould be consid ered wh en initi ating th era py with lamivudine tablets (HBV): - Due to hi gh rat es of resi st an ce d e v elopm ent in t r e at ed p ati ents, initi ation of t reatm ent with lamivudine tablets (HBV) should only be consid e r ed wh en the use of an alt e rn ative ant ivi ral a g ent with a hi gh er g en etic b arri er to r esist an ce is not av ail able or app rop ri a t e. - Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in p ati ents co -in fect ed with H I V, h e p atitis C vi rus (HC V), or h e p atitis d elta vi rus. - Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in liv er t ra nspl ant recipi ents or in p a ti ents with ch ronic h ep atiti

Resumen del producto:

Lamivudine tablets (HBV), 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side.           Bottle of 60 tablets                                               NDC 31722--752-60           Bottle of 600 tablets                                             NDC 31722--752-06           Blister card of 10 Unit-dose tablets                     NDC 31722--752-31           Blister pack of 100 (10x10) Unit-dose tablets     NDC 31722--752-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LAMIVUDINE - LAMIVUDINE TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE TABLETS (HBV) SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMIVUDINE TABLETS
HBV).
LAMIVUDINE TABLETS (HBV) FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
EXACERBATIONS
OF HEPATITIS B, AND RISK OF HIV-1 RESISTANCE IF LAMIVUDINE TABLETS
(HBV) IS USED IN
PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION
_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. (5.1)
• SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO HAVE DISCONTINUED ANTI-
HEPATITIS B THERAPY (INCLUDING LAMIVUDINE TABLETS (HBV) MONITOR
HEPATIC FUNCTION CLOSELY IN THESE PATIENTS
AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS B TREATMENT. (5.2)
• LAMIVUDINE TABLETS (HBV) CONTAIN A LOWER DOSE OF THE SAME ACTIVE
INGREDIENT (LAMIVUDINE) AS LAMIVUDINE
TABLETS AND ORAL SOLUTION USED TO TREAT HIV-1 INFECTION. HIV-1
RESISTANCE MAY EMERGE IN CHRONIC HEPATITIS
B PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV1 INFECTION BECAUSE THE
LAMIVUDINE DOSAGE IN LAMIVUDINE
TABLETS (HBV) IS SUBTHERAPEUTIC AND MONOTHERAPY IS INAPPROPRIATE FOR
THE TREATMENT OF HIV-1 INFECTION.
HIV COUNSELING AND TESTING SHOULD BE OFFERED TO ALL PATIENTS BEFORE
BEGINNING TREATMENT WITH LAMIVUDINE
TABLETS (HBV) AND PERIODICALLY DURING TREATMENT. (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions, Coadministration with Other Removed –
Medications Containing Lamivudine or
Emtricitabine 05/2017
(pre vious5.4)
INDICATIONS AND USAGE
• Lamivudine tablets (HBV) are a nucleoside analogue reverse
transcriptase inhibitor indicated for the treatment of chronic
hepatitis B virus infection associated with evidence of hepatitis B
viral replication and activ