LAMIVUDINE AND ZIDOVUDINE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Rebel Distributors Corp

INN (שם בינלאומי):

LAMIVUDINE

הרכב:

LAMIVUDINE 150 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Lamivudine and zidovudine tablets, a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of HIV-1 infection. Lamivudine and zidovudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the product. Fetal Risk Summary: There are no adequate and well-controlled studies 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 embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). Lamivudine and zidovudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry: To mon

leaflet_short:

Lamivudine and zidovudine tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are available as white, scored, film-coated, convex, oval tablets, debossed on both tablet faces, such that when broken in half, the full "TVL2" code is present on both halves of the tablet ("TV" on one face and "L2" on the opposite face of the tablet) in bottles of 2. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LAMIVUDINE AND ZIDOVUDINE- LAMIVUDINE AND ZIDOVUDINE TABLET, FILM
COATED
REBEL DISTRIBUTORS CORP
----------
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)
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
with renal or he