EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet, f

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8), EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

제공처:

Camber Pharmaceuticals, Inc.

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. •  Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see Warnings and Precautions ( 5.2)]. •  Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see Drug Interactions ( 7.3) and Clinical Pharmacology ( 12.3)]. Antiretroviral Pregnancy Registry There is a pregnancy exposure registry that m

제품 요약:

Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets 600 mg/200 mg/300 mg are white to off-white colored, capsule shaped, film-coated tablets debossed with ‘H’ on one side and ‘128’ on the other side. Each bottle contains 30 tablets (NDC 31722-736-30) and silica gel desiccant, and is closed with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. •      Keep container tightly closed. •      Dispense only in original container.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE -
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EFAVIRENZ,
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR EFAVIRENZ, EMTRICITABINE AND
TENOFOVIR DISOPROXIL
FUMARATE TABLETS.
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS,
FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B VIRUS (HBV) HAVE BEEN
REPORTED IN PATIENTS
COINFECTED WITH HBV AND HIV-1 WHO HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE (FTC) AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), AND
MAY OCCUR WITH
DISCONTINUATION OF EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL
FUMARATE. CLOSELY
MONITOR HEPATIC FUNCTION WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP
FOR AT LEAST SEVERAL
MONTHS IN PATIENTS WHO ARE COINFECTED WITH HIV-1 AND HBV AND
DISCONTINUE EFAVIRENZ,
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. IF APPROPRIATE,
INITIATION OF ANTI-
HEPATITIS B THERAPY MAY BE WARRANTED. ( 5.1)
INDICATIONS AND USAGE
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are
a three-drug combination of
efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and
emtricitabine (FTC) and tenofovir
disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse
transcriptase inhibitors, and is indicated
as a complete regimen or in combination with other antiretroviral
agents for the treatment of HIV-1
infection in adults and pediatric patients weighing at least 40 kg. (
1)
DOSAGE AND ADMINISTRATION
• Testing: Consult Full Prescribing Information for important
testing recommendations prior to initiation
and during treatment with efavirenz, emtricitabine and tenofovir
dis