LAMIVUDINE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lannett Company, Inc.

INN (Mezinárodní Name):

LAMIVUDINE

Složení:

LAMIVUDINE 10 mg in 1 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Lamivudine oral solution, USP is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.  Limitations of Use:   -  The dosage of this product is for HIV-1 and not for HBV. Lamivudine oral solution is 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 difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) . The APR uses the MACDP as the U.S. reference population for birth defects in the gene

Přehled produktů:

Lamivudine Oral Solution, USP is a clear, colorless, strawberry flavored liquid. Each mL of the solution contains 10 mg of lamivudine. Packaged as follows: Plastic bottle of 240 mL (NDC 54838-566-70) with child-resistant closure. This product does not require reconstitution. Recommended Storage: Store in tightly closed bottles at 25°C (77°F) [see USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LAMIVUDINE- LAMIVUDINE SOLUTION
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMIVUDINE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LAMIVUDINE ORAL
SOLUTION.
LAMIVUDINE ORAL SOLUTION, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: EXACERBATIONS OF HEPATITIS B, AND DIFFERENT FORMULATIONS OF
LAMIVUDINE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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. MONITOR HEPATIC FUNCTION CLOSELY IN
THESE PATIENTS
AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS B TREATMENT. (5.1)
PATIENTS WITH HIV-1 INFECTION SHOULD RECEIVE ONLY DOSAGE FORMS OF
LAMIVUDINE
APPROPRIATE FOR TREATMENT OF HIV-1. (5.1)
INDICATIONS AND USAGE
Lamivudine oral solution, USP is a nucleoside analogue reverse
transcriptase inhibitor indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection.
Limitations 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 either once
or twice daily. Dose should be
calculated on body weight (kg) and should not exceed 300 mg daily.
(2.2)
Patients with Renal Impairment: Doses of lamivudine must be adjusted
in accordance with renal
function. (2.3)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 10 mg per mL (3)
CONTRAINDICATIONS
Lamivudine oral solution is contraindicated in patients with previous
hypersensitivity reaction to
lamivudine. (4)
WARNINGS AND PRECAUTIONS
Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV
variants associated with
lamivudine-containing antiretroviral regimens has been reported. (5.1)
Lactic acidosis and severe hepatomegaly with steatos