Prezista

Prezista

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Darunavir
Indications/Uses
Treatment of HIV-1 infections in adult & paed (≥6 yr) in combination w/ ritonavir & other antiretroviral agents.
Dosage/Direction for Use
Adult 18-65 yr Treatment-naive & treatment-experienced (w/ no darunavir resistance associated substitution) 800 mg w/ ritonavir 100 mg once daily. Treatment experienced (≥1 darunavir resistance associated substitution) 600 mg bd w/ ritonavir 100 mg bd. Childn 6 to <18 yr Dosage selection based on body wt ≥20 to <30 kg: 375 mg w/ ritonavir 50 mg bd. ≥30 to <40 kg: 450 mg w/ ritonavir 60 mg bd. ≥40 kg: 600 mg w/ ritonavir 100 mg bd.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Co-administration w/ drugs that are highly dependent on CYP3A for clearance & w/ narrow therapeutic index. Alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam & triazolam, St. John’s wort, lovastatin, simvastatin, rifampin, sildenafil for treatment of pulmonary arterial hypertension.
Special Precautions
Preexisitng or severe liver dysfunction including active hepatitis B or C, cirrhosis. Interrupt or discontinue treatment if new/worsening liver dysfunction occur. Stevens-Johnson syndrome, toxic epidermal necrolysis (discontinue treatment). Sulfonamide allergy & haemophilia. New onset or exacerbation of DM & hyperglycemia. Fat redistribution. Immune reconstitution syndrome. Resistance/cross-resistance. Pregnancy & lactation. Elderly, childn <6 yr.
Adverse Reactions
Adult/Paed Diarrhoea, headache, abdominal pain, rash, vomiting, nausea, fatigue, laboratory test abnormalities. Adult Anorexia, abdominal distension, dyspepsia, asthenia, DM.
Drug Interactions
NRTIs (didanosine), PIs (indinavir, lopinavir/ritonavir, saquinavir), CCR5 co-receptor antagonists (maraviroc), antiarrhythmics, warfarin, carbamazepine, phenobarb, phenytoin, trazodone, desipramine, clarithromycin, ketoconazole, itraconazole, voriconazole, colchicines, rifabutin, metoprolol, timolol, parenteral midazolam, felodipine, nifedipine, nicardipine, systemic dexamethasone, inhaled fluticasone, bosentan, pravastatin, atorvastatin, rosuvastatin, cyclosporine, tacrolimus, sirolimus, inhaled salmeterol, methadone, buprenorphine/naloxone, risperidone, thioridazine, ethinyl estradiol, norethindrone, sildenafil, vardenafil, tadalafil, sertraline, paroxetine.
MIMS Class
ATC Classification
J05AE10 - darunavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Prezista film-coated tab 600 mg
Packing/Price
1's
Form
Prezista film-coated tab 400 mg
Packing/Price
1's
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