Rx Item-Prezista 800Mg Tab 30 By J O M Pharma

PREZISTA- darunavir ethanolate tablet, film coated
A-S Medication Solutions

1 INDICATIONS AND USAGE

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)].

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation of PREZISTA/ritonavir


​ In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus [see Microbiology (12.4)]. Refer to Dosage and Administration (2.3), (2.4) and (2.5) for dosing recommendations.

​ Appropriate laboratory testing such as serum liver biochemistries should be conducted prior to initiating therapy with PREZISTA/ritonavir [see Warnings and Precautions (5.2)].

2.2 Monitoring During Treatment with PREZISTA/ritonavir
​ Patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases should be monitored for elevation in serum liver biochemistries, especially during the first several months of PREZISTA/ritonavir treatment [see Warnings and Precautions (5.2)].

2.3 Recommended Dosage in Adult Patients
PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.

Patients who have difficulty swallowing PREZISTA tablets can use the 100 mg per mL PREZISTA oral suspension.

RX ITEM-Prezista 800Mg Tab 30 By J O M P
NDC 59676-0566-30 UPC/GTIN No.3-59676-56630-4 Mfg.Part No.56630 800 tablet , film-coated , red , oval oblong Debossed

Prezista 800Mg Tab 30 By J O M Pharma
BRAND: PREZISTA NDC: 59676-0566-30,59676056630 UPC: 3-59676-56630-4,359676566304 J/O/M Pharma Services

DARUNAVIR ETHANOLATE ORAL
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