Zuellig Pharma
Concise Prescribing Info
HIV infection in antiretroviral treatment-experienced adult patients (in combination w/ 100-mg ritonavir & other antiretroviral agents).
Dosage/Direction for Use
Adult 600 mg bd w/ ritonavir 100 mg bd.
Should be taken with food.
Hypersensitivity. Not to be co-administered w/ drugs highly dependent on CYP3A clearance eg, alfuzosin, astemizole, cisapride, colchicine (in patients w/ renal &/or hepatic impairment), dapoxetine, dronedarone, elbasvir/grazoprevir, ergot alkaloids, ivabradine, lomitapide, lovastatin, lurasidone, PO midazolam, naloxegol, pimozide, ranolazine, sildenafil (for PAH), simvastatin, terfenadine, triazolam. Not to be used w/ potent CYP3A inducers-containing products eg, rifampin or St. John's wort.
Special Precautions
Severe skin reactions, discontinue if signs & symptoms of severe skin reactions developed; sulfonamide allergy. Patients w/ hepatic impairment, hepatotoxicity, lab testing should be conducted prior & during treatment. Renal impairment. Hemophilia. Metabolic disorders, new onset DM, hyperglycemia, consider to measure fasting serum lipids & blood glucose; lipid disorders should be managed as clinically appropriate. Immune reconstitution inflammatory syndrome. Concomitant use w/ CYP3A-, CYP2D6-metabolized drugs or P-gp transported drugs; CYP3A inducers & inhibitors. May affect ability to drive or operate machinery. Pregnancy. Not to be used during lactation. Not to be used in childn <12 yr & adolescents 12-17 yr. Elderly ≥65 yr.
Adverse Reactions
Diarrhoea, hypertriglyceridaemia, hypercholesterolaemia, nausea, abdominal pain, vomiting, increased hepatic enzymes, rash.
Drug Interactions
Increased plasma conc of CYP3A- & CYP2D6-metabolized products or P-gp transports. Reduced plasma conc of drugs w/ active metabolites formed by CYP3A. Increased clearance of darunavir & ritonavir w/ CYP3A inducers. Decreased clearance of darunavir & ritonavir w/ CYP3A inhibitors. Increased exposure to alfuzosin, ranolazine, amiodarone, bepridil, disopyramide, dronedarone, flecainide, mexiletine, propafenone, systemic lidocaine, quinidine, clarithromycin, astemizole, terfenadine, ergot alkaloids, cisapride. Decreased exposure to sertraline, paroxetine, ethinylestradiol, norethindrone. Reduced antiplatelet activity of clopidogrel. Increased risk of CV adverse events w/ salmeterol.
MIMS Class
ATC Classification
J05AE10 - darunavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Prezista FC tab 600 mg
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