국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ETRAVIRINE (UNII: 0C50HW4FO1) (ETRAVIRINE - UNII:0C50HW4FO1)
Carnegie Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14)] None.
Etravirine 100 mg tablets are supplied as white to off-white, uncoated, oval shaped tablet, debossed "CP112" on one side and plain on other side. Etravirine 200 mg tablets are supplied as white to off-white, uncoated, oval shaped tablet, debossed "CP113" on one side and plain on other side. Etravirine tablets are packaged in bottles in the following configuration: Store etravirine tablets at 25°C (77°F); with excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Store in the original bottle. Keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
Abbreviated New Drug Application
ETRAVIRINE- ETRAVIRINE TABLET CARNEGIE PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ETRAVIRINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ETRAVIRINE TABLETS. ETRAVIRINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2008 RECENT MAJOR CHANGES Indications and Usage (1) 11/2018 Dosage and Administration: Recommended Dosage During Pregnancy (2.2) 11/2018 Warnings and Precautions: Severe Skin and Hypersensitivity Reactions (5.1) 07/2019 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions (5.2) 11/2018 Immune Reconstitution Syndrome (5.3) 07/2019 INDICATIONS AND USAGE Etravirine is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 2 years of age and older. (1) DOSAGE AND ADMINISTRATION Adult patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. (2.1, 2.2, 2.4) Pregnant patients: 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. (2.2) Pediatric patients (2 years to less than 18 years of age and weighing at least 10 kg): dosage of etravirine is based on body weight and should not exceed the recommended adult dose. Etravirine tablets should be taken following a meal. (2.3) DOSAGE FORMS AND STRENGTHS Tablets: 100 mg, and 200 mg (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Severe, potentially life threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction, toxic epidermal necrolysis and erythema multiforme. Immediately discontinue treatment if severe hypersensitivity, severe rash or rash with systemic symptoms or liver transaminase elevations develops and monitor clinical status, including liver transaminases closely. (5.1) Monitor for immune reconstitution syndrome and fat redistribution. (5.3,5.4) 전체 문서 읽기