Zuellig Pharma
Concise Prescribing Info
HIV infection in antiretroviral treatment-experienced adult patients (in combination w/ 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, dapoxetine, dronedarone, elbasvir/grazoprevir, ergot alkaloids, ivabradine, lomitapide, lovastatin, lurasidone, midazolam, naloxegol, pimozide, ranolazine, sildenafil, simvastatin, terfenadine, triazolam; rifampin or St. John's wort.
Special Precautions
Severe skin reactions. Patients w/ sulfonamide allergy & haemophilia. New onset DM, hyperglycemia, DM exacerbation. Fat redistribution & metabolic disorders. 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. Hepatotoxicity. Severe hepatic impairment. 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, lipodystrophy, increased hepatic enzymes, rash, lipodystrophy, laboratory abnormalities.
Drug Interactions
Increased conc w/ delavirdine, itraconazole, isavuconazole ketoconazole, posaconazole, voriconazole, simeprevir. Decreased exposure w/ lopinavir/ritonavir, saquinavir, systemic dexamethasone, boceprevir, telaprevir. Increased exposure w/ indinavir, rifabutin. Increased exposure of maraviroc, digoxin, lomitapide. Increased exposure to alfuzosin, ranolazine, amiodarone, bepridil, disopyramide, dronedarone, flecainide, mexiletine, propafenone, systemic lidocaine, quinidine, clarithromycin, colchicine, astemizole, terfenadine, lumefantrine, lurasidone, pimozide, risperidone, thioridazine, quetiapine, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil, ergot alkaloids, cisapride, elbasvir/grazoprevir, ecaprevir/pibrentasvir, immunosuppressants. Increased plasma conc of apixaban, dabigatran , edoxaban, rivaroxaban, clonazepam, amitriptyline, desipramine, imipramine, nortriptyline, trazodone, clotrimazole, fluconazole, dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine, perphenazine, carvedilol, metoprolol, timolol, betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone, bosentan, HMG-CoA reductase inhibitors, fentanyl, oxycodone, tramadol, ticagrelor,sedatives/hypnotics. Decreased plasma conc w/ phenobarb, phenytoin, rifampin, rifapentine, St. John’s wort. Decreased exposure to sertraline, paroxetine, artemether, ethinylestradiol, norethindrone. Potential of hyperkalemia w/ drospirenone-containing product. Increased risk of CV adverse events w/ salmeterol. Not recommended w/ PDE-5 inhibitors. Elvitegravir, ivabradine, warfarin, carbamazepine, domperidone, buprenorphine, methadone, naloxegol, sildenafil, tadalafil, dapoxetine, fesoterodine, solifenacin.
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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