PREZISTA darunavir tablet film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

darunavir ethanolate (UNII: 33O78XF0BW) (darunavir - UNII:YO603Y8113)

Доступно од:

Avera McKennan Hospital

INN (Међународно име):

darunavir ethanolate

Састав:

darunavir 800 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

New Drug Application

Карактеристике производа

PREZISTA- DARUNAVIR TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2, 2.4, 2.5)
06/2016
Contraindications (4)
09/2016
Warnings and Precautions, Resistance/Cross-Resistance (5.10)
Removed 06/2016
INDICATIONS AND USAGE
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor
indicated for the treatment of HIV-1 infection in
adult and pediatric patients 3 years of age and older. PREZISTA must
be co-administered with ritonavir
(PREZISTA/ritonavir) and with other antiretroviral agents. (1)
DOSAGE AND ADMINISTRATION
T e sting:
In treatment-experienced patients, treatment history genotypic and/or
phenotypic testing is recommended prior to
initiation of therapy with PREZISTA/ritonavir to assess drug
susceptibility of the HIV-1 virus (2.1, 12.4)
Monitor serum liver chemistry tests before and during therapy with
PREZISTA/ritonavir. (2.1, 2.2, 5.2)
Treatment-naïve adult patients and treatment-experienced adult
patients with no darunavir resistance associated
substitutions: 800 mg (one 800 mg tablet) taken with ritonavir 100 mg
once daily and with food. (2.3)
Treatment-experienced adult patients with at least one darunavir
resistance associated substitution: 600 mg (one 600
mg tablet) taken with ritonavir 100 mg twice daily and with food.
(2.3)
Pregnant patients: 600 mg (one 600 mg tablet) taken with ritonavir 100
mg twice daily and with food. (2.4)
Pediatric patients (3 to less than 18 years of age and weighing at
least 10 kg): dosage of PREZISTA and ritonavir is
based on body weight and should not exceed the adult dose. PREZISTA
should be taken with ritonavir and with food.
(2.5)
PREZISTA/ritonavir is not recommended for use in patients with severe
hepatic impairment. (2.6)
DOSAGE FORMS AND STRENGT