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:

Camber Pharmaceuticals, Inc.

INN (International Name):

EFAVIRENZ

Composition:

EFAVIRENZ 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Efavirenz tablets 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 (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)]. Tetratogenic Effects Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz tablets during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry at 1-80

Product summary:

Efavirenz tablets, USP are available as follows: Tablets 600 mg are yellow, capsular-shaped, film-coated tablets debossed with ‘H’ on one side and ‘4’ on the other side. Bottles of 30                              NDC 31722-504-30 Bottles of 250                            NDC 31722-504-25 Efavirenz tablets, USP should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EFAVIRENZ - EFAVIRENZ 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 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 (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 needed for dose adjustment when coadministered with
rifampin. (5.4)
• _Serious psychiatric symptoms:_ Immediate medical evaluation i