PREZISTA- darunavir ethanolate tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

DARUNAVIR ETHANOLATE (UNII: 33O78XF0BW) (darunavir - UNII:YO603Y8113)

Доступна с:

State of Florida DOH Central Pharmacy

ИНН (Международная Имя):

DARUNAVIR ETHANOLATE

состав:

DARUNAVIR ETHANOLATE 400 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

PREZISTA® , co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients. PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of HIV infection in pediatric patients 6 years of age and older [see Use in Specific Populations (8.4) ]. This indication is based on 24-week analyses of plasma HIV RNA levels and CD4+ cell counts from an open-label Phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age. In treatment-experienced adult and pediatric patients, the following poi

Обзор продуктов:

PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with "75" on one side and "TMC" on the other side. PREZISTA (darunavir) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir per tablet. Each tablet is debossed with "150" on one side and "TMC" on the other side. PREZISTA (darunavir) 300 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 300 mg of darunavir per tablet. Each tablet is debossed with "300" on one side and "TMC114" on the other side. PREZISTA (darunavir) 400 mg tablets are supplied as light orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 400 mg of darunavir per tablet. Each tablet is debossed with "400" on one side and "TMC" on the other side. PREZISTA (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir per tablet. Each tablet is debossed with "600" on one side and "TMC" on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage: Store PREZISTA tablets at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F).

Статус Авторизация:

New Drug Application

Характеристики продукта

PREZISTA - DARUNAVIR ETHANOLATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREZISTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREZISTA.
PREZISTA (DARUNAVIR) TABLET, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL – 2006
RECENT MAJOR CHANGES
• Contraindications (4)
04/2010
• Warnings and Precautions
• Severe Skin Reactions (5.3)
01/2010
INDICATIONS AND USAGE
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor
indicated for the treatment of HIV infection in
adult patients. PREZISTA is also indicated for the treatment of HIV
infection in pediatric patients 6 years of age and older.
PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir)
and with other antiretroviral agents. (1)
DOSAGE AND ADMINISTRATION
Treatment-naïve adult patients: 800 mg (two 400 mg tablets) taken
with ritonavir 100 mg once daily and with food. (2.1)
Treatment-experienced adult patients: 600 mg (one 600 mg tablet or two
300 mg tablets) taken with ritonavir 100 mg
twice daily and with food. (2.1)
Pediatric patients (6 to < 18 years of age and weighing at least 44
lbs (20 kg)): dosage of PREZISTA and ritonavir is
based on body weight and should not exceed the treatment-experienced
adult dose. Do not use once daily dosing in
pediatric patients. PREZISTA tablets should be taken with ritonavir
twice daily and with food. (2.2)
PREZISTA/ritonavir is not recommended for use in patients with severe
hepatic impairment. (2.3)
DOSAGE FORMS AND STRENGTHS
75 mg tablets, 150 mg tablets, 300 mg tablets, 400 mg tablets, and 600
mg tablets (3)
CONTRAINDICATIONS
Co-administration with alfuzosin, dihydroergotamine, ergonovine,
ergotamine, methylergonovine, cisapride, pimozide, oral
midazolam, triazolam, St. Johns Wort, lovastatin, simvastatin,
rifampin and sildenafil (for treatment of pulmonary arterial
hypertension). (4)
Due to the need for co-administration of PREZISTA with 100