LAMIVUDINE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Prasco Laboratories

INN (שם בינלאומי):

LAMIVUDINE

הרכב:

LAMIVUDINE 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)]. The following points should be considered when initiating therapy with Lamivudine tablets (HBV): Lamivudine tablets (HBV) are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine 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 substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The

leaflet_short:

Lamivudine tablets (HBV) contain 100 mg of lamivudine, are butterscotch‑colored, film‑coated, biconvex, capsule‑shaped tablets imprinted with “GX CG5” on one side. Packaged as follows: Bottles of 60 tablets (NDC 66993-478-60) with child‑resistant closure. Store Lamivudine tablets (HBV) at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

LAMIVUDINE- LAMIVUDINE TABLET, FILM COATED
PRASCO LABORATORIES
----------
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: EXACERBATIONS OF HEPATITIS B AND RISK OF HIV-1 RESISTANCE IF
LAMIVUDINE TABLETS (HBV) ARE USED IN PATIENTS WITH UNRECOGNIZED OR
UNTREATED HIV-1 INFECTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INDICATIONS AND USAGE
Lamivudine tablets (HBV) are a nucleoside analogue reverse
transcriptase inhibitor indicated for the
treatment of chronic hepatitis B virus (HBV) infection associated with
evidence of hepatitis B viral
replication and active liver inflammation. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Lamivudine tablets (HBV) are contraindicated in patients with previous
hypersensitivity reaction to
lamivudine. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common reported adverse reactions in those receiving
Lamivudine tablets (HBV) (incidence
• 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. (5.1 )
• LAMIVUDINE TABLETS (HBV) CONTAIN A LOWER DOSE OF THE SAME ACTIVE
INGREDIENT
(LAMIVUDINE) AS EPIVIR TABLETS AND ORAL SOLUTION USED TO TREAT HUMAN
IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION. HIV-1 RESISTANCE MAY
EMERGE IN
CHRONIC HEPATITIS B PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1
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 TABL