EFAVIRENZ tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8)

Available from:

REMEDYREPACK INC.

INN (International Name):

EFAVIRENZ

Composition:

EFAVIRENZ 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. - Efavirenz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. - Coadministration of efavirenz with elbasvir and grazoprevir is contraindicated [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Efavirenz during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263. Risk Summary There are retrospective case reports of neural tube defects in infants whose mothers were expos

Product summary:

Efavirenz tablets USP are available as follows: Efavirenz Tablets USP 600 mg are off white coloured, capsule shaped, film coated tablets imprinted with "600" on one side and plain on other side. NDC: 70518-1100-00 PACKAGING: 30 in 1 BLISTER PACK Efavirenz tablets USP 600 mg should be stored at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EFAVIRENZ- EFAVIRENZ TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EFAVIRENZ TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EFAVIRENZ
TABLETS.
EFAVIRENZ TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Nervous System Symptoms (5.6) 10/2019
Warnings and Precautions, Immune Reconstitution Syndrome (5.12)
10/2019
INDICATIONS AND USAGE
Efavirenz is a non-nucleoside reverse transcriptase inhibitor
indicated in combination with other
antiretroviral agents for the treatment of human immunodeficiency
virus type 1 infection in adults and in
pediatric patients at least 3 months old and weighing at least 3.5 kg
(1)
DOSAGE AND ADMINISTRATION
Efavirenz tablets USP should be taken orally once daily on an empty
stomach, preferably at bedtime.
(2)
Recommended adult dose: 600 mg. (2.2)
With voriconazole, increase voriconazole maintenance dose to 400 mg
every 12 hours and decrease
efavirenz dose to 300 mg once daily using the capsule formulation.
(2.2)
With rifampin, increase Efavirenz dose to 800 mg once daily for
patients weighing 50 kg or more. (2.2)
Pediatric dosing is based on weight. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg. ( 3)
CONTRAINDICATIONS
Patients with previously demonstrated hypersensitivity (eg,
Stevens-Johnson syndrome, erythema
multiforme, or toxic skin eruptions) to any of the components of this
product. ( 4)
Coadministration of efavirenz with elbasvir/grazoprevir.
WARNINGS AND PRECAUTIONS
_QTc prolongation:_ Consider alternatives to Efavirenz in patients
taking other medications with a known
risk of Torsade de Pointes or in patients at higher risk of Torsade de
Pointes. (5.2)
_Do not use as a single agent_ or add on as a sole agent to a failing
regimen. Consider potential for cross
resistance when choosing other agents. ( 5.3)
Not recommended with ATRIPLA, which contains efavirenz, emtricitabine,
and tenofovir disoproxil
fumarate, unless nee