EFAVIRENZ- efavirenz tablet, film coated

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 tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.Efavirenz tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., 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) ]. Coadministration of efavirenz with elbasvir and grazoprevir is contraindicated [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ]. There is a

Product summary:

Efavirenz Tablets, USP are available containing 600 mg of efavirenz, USP. The 600 mg tablets are yellow, film-coated, capsule shaped, unscored tablets debossed with MYLAN on one side of the tablet and 233 on the other side. They are available as follows: NDC 0378-2233-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in original container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EFAVIRENZ- EFAVIRENZ TABLET, FILM COATED
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
Dosage and Administration, Hepatic Function ( 2.1) 10/2017
Contraindications, Antiviral Agents ( 4) 10/2017
Warnings and Precautions, Psychiatric Symptoms ( 5.5) 01/2017
Warnings and Precautions, Hepatotoxicity ( 5.9) 10/2017
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 should be taken orally once daily on an empty
stomach, preferably at bedtime. ( 2)
Recommended adult dose: 600 mg. ( 2.2)
Pediatric dosing is based on weight. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg. ( 3)
CONTRAINDICATIONS
Patients with previously demonstrated hypersensitivity (e.g.,
Stevens-Johnson syndrome, erythema multiforme, or
toxic skin eruptions) to any of the components of this product. ( 4)
Coadministration of efavirenz with elbasvir/grazoprevir. ( 4)
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
needed for dose adjustment when coadministered with rifampin. ( 5.4)
_Serious psychiatric symptoms:_ Immediate medical evaluation is
recommended for serious psych