Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DARUNAVIR ETHANOLATE (UNII: 33O78XF0BW) (DARUNAVIR - UNII:YO603Y8113)
Janssen Products LP
darunavir ethanolate
darunavir 75 mg
ORAL
PRESCRIPTION DRUG
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4)and Clinical Studies (14)] . Co-administration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples of these drugs and other contraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see Drug Interactions (7.3)] . Due to the need for co-administration of PREZISTA with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - Alpha 1-adrenoreceptor antagonist: alfuzosin - Anti-gout: colchicine, in patients with renal a
PREZISTA ® (darunavir) 100 mg per mL oral suspension is a white to off-white opaque liquid supplied in amber-colored multiple-dose bottles containing 100 mg of darunavir per mL packaged with a 6 mL oral dosing syringe with 0.2 mL gradations. PREZISTA ® (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets 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 debossed with "150" on one side and "TMC" on the other side. PREZISTA ® (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets debossed with "600MG" on one side and "TMC" on the other side. PREZISTA ® (darunavir) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets debossed with "800" on one side and "T" on the other side. PREZISTA is packaged in bottles in the following configuration: Storage PREZISTA Oral Suspension PREZISTA Tablets Keep PREZISTA out of reach of children.
New Drug Application
PREZISTA- DARUNAVIR TABLET, FILM COATED PREZISTA- DARUNAVIR SUSPENSION JANSSEN PRODUCTS LP ---------- 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) ORAL SUSPENSION PREZISTA (DARUNAVIR) TABLET, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 RECENT MAJOR CHANGES Contraindications ( 4) 4/2022 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 Testing: 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 STRENGTHS Oral suspension: 100 mg per mL ( 3) Tablets: 75 mg, 150 mg Prečítajte si celý dokument