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:

Mylan Pharmaceuticals 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. 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. There are retrospective case reports of neural tube defects in infants whose mothers were exposed to efavirenz-containing regimens in the first trimester of pregnancy. Prospective pregnancy data from the Antiretroviral Pregnancy Registry are not sufficient to adequately assess this risk. Available data from the Antiretroviral Pregnancy Registry show no difference in the risk of overall major birth defects compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Pr

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
MYLAN PHARMACEUTICALS 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
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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (> 5%, moderate-severe) are impaired
concentration, abnormal dreams,
rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting.
(6)
Efavirenz tablets 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)
Tablets: 600 mg. (3)
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)
_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 ot