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Lopinavir 200mg/ Ritonavir 50mg



30/60 tablets in HAPE plastic bottle




Lopinavir and Ritonavir are inhibitors of the HIV-1 protease, prevents cleavage of the Gag-Pol polyprotein, resulting in the production of immature, non-infectious viral particles.



LORITEC is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.



Adult Patients Therapy-Naïve Patients: LORITEC tablets 400/100 mg (given as two 200/50 mg tablets) twice daily taken with or without food.

Therapy-Experienced Patients: Ones daily administration of LORITEC is not recommended in therapy-experienced patients. LORITEC tablets 400/100 mg (given as two 200/50 mg tablets) twice daily taken with or without food.

Concomitant Therapy: Efavirenz, nevirapine, (fos) amprenavir or nelfinavir LORITEC tablets should not be administered as a once daily regimen in combination with efavirenz, nevirapine,(fos) amprenavir or nelfinavir. A dose increase is recommended for all patients who use LORITEC tablets. The recommented dose of LORITEC tablets is 500/125 mg (such as two 200/50 tablets and half 200/50 mg tablet) twice daily in combination with efavirenz, nevirapine, (fos)amprenavir or nelfinavir.



LORITEC is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g.,Stevens-Johnson syndrome, erythema multiforme) to any of its ingredients,

including ritonavir. Co-administration of LORITEC is contraindicated with drugs highly dependent on CYP3A for which elevated plasma concentrations are associated with serious and/or life-threatening reactions. Co-administration of LORITEC is contraindicated with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance.



The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, asthenia, vomiting, headache and dyspepsia.



lCoadministration of LORITEC can after the concentrations of other drugs and other drugs may alter theconcentrations of lopinavir.

The potential for drug-drug interactions must be considered prior to and during therapy. Lopinavir/ritonavir is an inhibitor of CYP3A and may increase plasma concentrations of agents that are primarily metabolized by CYP3A. Agents that are extensively metabolized by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in AUC(>3-fold) when co-administered with LORITEC. Additinally, LORITEC induces glucuronidation. Lopinavir/ritonavir is a CYP3A substrate; therefore, drugs that induce CYP3A may decrease lopinavir plasma concentrations and reduce LORITEC’s therapeutic effect. Although not observed in the LORITEC /ketoconazole drug interaction study, co-administration of LORITEC and other drugs that inhibit CYP3A may increase lopinavir plasma concentrations.


Use In Specific Populations


Pregnancy Category C

Embryonic and fetal developmental toxicities (early resorption, decresed fetal viability, decreased fetal body weight, increased incidence of secletal variations

and skeletal ossification deldays) occurred in rats at a matemally toxic dosage, no adequate and well-controlled studies in pregnant women, LORITEC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To monitor matemal-fetal outcomes of pregnant women exposed to LORITEC, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register partients.


Pediatric Use

The safety, efficacy and pharmacokinetic profiles of LORITEC in pediatric patients below the age of 14 days have not been established. LORITEC once daily has not been evaluated in pediatric patients.

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