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Darunavir tablets
PREZISTA™
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FDA Approval: |
June 2006 |
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Indication: |
HIV-1 infection in treatment-experienced adults |
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Pharmacology: |
Protease inhibitor |
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Usual Dose: |
Darunavir 600 mg plus ritonavir 100 mg twice daily, with food |
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Contraindications: |
Hypersensitivity to any ingredient Concomitant ergot derivatives, terfenadine, astemizole, cisapride, pimozide,
midazolam, triazolam; also refer to ritonavir labeling |
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Warnings: |
Discontinue if severe rash occurs Caution recommended in patients
with sulfonamide allergy
May increase plasma levels of CYP450 3A4 substrates
Protease inhibitors have been associated with diabetes,
hyperglycemia, and ketoacidosis
Caution is recommended in patients with liver insufficiency;
consider discontinuation if liver disease becomes worse
Protease inhibitors have been associated with increased bleeding
in hemophilia patients.
Immune reconstitution syndrome and fat redistribution have
occurred during antiretroviral therapy.
Patients on hormonal contraceptives should use nonhormonal
contraception during treatment.
Breastfeeding should be avoided because of the potential risk of
HIV transmission to the infant.
Safety and effectiveness not established in pediatric patients |
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Pregnancy Category: |
B |
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Side Effects: |
Frequency >10%:
Diarrhea, nausea, headache, nasopharyngitis Frequency >2%:
Vomiting, abdominal pain, constipation Elevated liver function
tests, pancrease, amylase, cholesterol, triglycerides Hyperglycemia,
hypoglycemia, hyperuricemia, hypoalbuminemia, hyponatremia,
hypernatremia, hypocalcemia, decreased bicarbonate Decreased white
blood cells, neutrophils, lymphocytes, platelets Increased PTT, PT |
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Drug Interactions: |
Amiodarone
Astemizole
Atorvastatin
Bepridil
Carbamazepine
Cisapride
Clarithromycin
Cyclosporine
Dexamethasone
Didanosine
Dihydroergotamine
Efavirenz
Ergonovine
Ergotamine
Ethinyl estradiol
Felodipine
Fluticasone, inhaled
Indinavir
Itraconazole
Ketoconazole
Lidocaine
Lopinavir/ritonavir
Lovastatin
Methadone
Methylergonovine
Midazolam
Nicardipine
Nifedipine
Norethindrone
Omeprazole
Paroxetine
Phenobarbital
Phenytoin
Pimozide
Pravastatin
Quinidine
Ranitidine
Rifabutin
Rifampin
Saquinavir
Sertraline
Sildenafil
Simvastatin
Sirolimus
St John's wort
Tacrolimus
Tadalafil
Terfenadine
Trazodone
Triazolam
Vardenafil
Voriconazole
Warfarin |
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