Monograph Details
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Infections & Infestations
> Viral infections
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KALETRA 200mg/50mg |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Protease inhibitor. |
| Generic Name |
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Lopinavir 200mg, ritonavir 50mg; tabs. |
| Also |
• KALETRA 100mg/25mg
• KALETRA ORAL SOLUTION
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| Indications |
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HIV infection. |
| Children |
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May use tabs if able to swallow whole and ≥15kg. Take twice daily with food. <6months: not recommended. ≥6months: 7 to <15kg: lopinavir/ritonavir 12mg/3mg per kg; 15–40kg: 10mg/2.5mg per kg; >40kg: max 400mg/100mg twice daily. Concomitant efavirenz, nevirapine or (fos)amprenavir: ≥6months: 7 to <15kg: 13mg/3.25mg per kg; 15–45kg: 11mg/2.75mg per kg; >45kg: max oral soln: 533mg/133mg twice daily; or max tabs: 400mg/100mg or 600mg/150mg twice daily. See literature. |
| Adults |
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Swallow tabs whole; take oral soln with food. Converting from caps to tabs or oral soln: Treatment-naive: Lopinavir/ritonavir 400mg/100mg (2 tabs or 5mL) twice daily or lopinavir/ritonavir 800mg/200mg (4 tabs or 10mL) once daily. Treatment-experienced: Lopinavir/ritonavir 400mg/100mg (2 tabs or 5mL) twice daily. Concomitant efavirenz, nevirapine, fosamprenavir (without ritonavir) or nelfinavir in treatment-experienced patients when reduced susceptibility to lopinavir is suspected: 600mg/150mg (3 tabs) twice daily. Concomitant efavirenz, nevirapine, amprenavir or nelfinavir: 533mg/133mg (6.5mL) twice daily. |
| Contraindications |
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Loss of virologic response or resistance with rifampin, St. John's wort. Drugs metabolized by CYP3A that may cause serious events if blood levels are elevated (eg, cisapride, ergots, pimozide, midazolam, triazolam). |
| Precautions |
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Suspend if pancreatitis occurs. History of, or risk factors for, pancreatitis (eg, elevated triglycerides). Hepatic impairment. Hepatitis. Diabetes. Monitor: lipids at baseline then periodically, ALT/AST in liver disease, for hyperglycemia or fat redistribution, hemophiliacs (for spontaneous bleed). Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Lovastatin, simvastatin, St. John's wort, rifampin, voriconazole: not recommended. Potentiates sildenafil, vardenafil, tadalafil (reduce dose of these), statins metabolized by CYP3A (eg, atorvastatin), fluticasone (avoid). Avoid oral soln with metronidazole, disulfiram. Monitor other antiretrovirals, warfarin. Increases levels of antiarrhythmics, dihydropyridine, calcium channel blockers, immunosuppressants (monitor); ketoconazole, itraconazole (avoid high doses); rifabutin (reduce rifabutin dose and monitor); clarithromycin (reduce clarithromycin dose in renal dysfunction), trazodone (reduce trazodone dose). Give didanosine 1 hour before or 2 hours after. Decreases levels of atovaquone, methadone, estrogen-containing oral contraceptives (use other or back-up contraception). Lopinavir levels decreased by anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), dexamethasone, efavirenz, nevirapine. Lopinavir levels may be increased by delavirdine, CYP3A inhibitors. May decrease zidovudine or abacavir levels. See literature. |
| Adverse Reactions |
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Diarrhea, GI upset, asthenia, headache, abdominal pain, rash, insomnia, pancreatitis, fat redistribution, hyperlipidemia, increased triglycerides. |
| How Supplied |
200mg/50mg—120
100mg/25mg—60
Soln—160mL (w. dose cup)
(Note: Capsules have been discontinued) |
| Additional Resources |
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• Related Prescribing Note |
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