EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Dostopno od:

Laurus Labs Limited

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: - in patients with a previous hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation [see Warnings and Precautions (5.8)] . - when coadministered with elbasvir and grazoprevir [see Warnings and Precautions (5.3) and Drug Interactions (7.5)]. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary: There are r

Povzetek izdelek:

Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets 600 mg/300 mg/300 mg are white colored, capsule shaped, biconvex, film coated tablets, debossed with ‘L65’ on one side and plain on the other side. They are available as follows:     Bottles of 30                                                      NDC 42385-928-30     Bottles of 90                                                      NDC 42385-928-90 S tore at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep the bottle tightly closed. Dispense in original container. Do not use if seal over bottle opening is broken or missing.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE -
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM
COATED
LAURUS LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EFAVIRENZ, LAMIVUDINE
AND TENOFOVIR DISOPROXIL FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR EFAVIRENZ, LAMIVUDINE AND TENOFOVIR
DISOPROXIL
FUMARATE TABLETS.
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2018
WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO
ARE CO-INFECTED WITH HBV AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) AND
HAVE
DISCONTINUED LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE. MONITOR
HEPATIC FUNCTION
CLOSELY IN THESE PATIENTS AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS
B TREATMENT. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6, 5.13,
5.14) 10/2019
Warnings and Precautions, Use with Interferon-
and Removed
Ribavirin-Based Regimens (previous
5.10) 10/2019
INDICATIONS AND USAGE
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are
three-drug combination of efavirenz
(EFV), a non-nucleoside reverse transcriptase inhibitor, and
lamivudine (3TC) and tenofovir disoproxil
fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors
and are indicated as a complete
regimen for the treatment of human immunodeficiency virus type 1
(HIV-1) infection in adult and pediatric
patients weighing at least 40 kg. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to initiation and during treatment with efavirenz,
lamivudine and tenofovir disoproxil
fumarate tablets, patients should be tested for hepatitis B virus
infection, and estimated creatinine
clearance, urine glucose, and urine protein should be obtained. (2.1)
Recommended dose: One tablet taken orally once daily on an