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Ritocom

Ritocom

lopinavir + ritonavir

Manufacturer:

Hetero Labs

Distributor:

Camber
Concise Prescribing Info
Contents
Lopinavir 200 mg, ritonavir 50 mg
Indications/Uses
In combination w/ other antiretroviral agents for HIV-1 infection.
Dosage/Direction for Use
Adult Therapy-naive patients 400 mg/100 mg bid or 800 mg/200 mg once daily. Therapy-experienced patients 400 mg/100 mg bid. In combination w/ efavirenz, nevirapine, (fos)amprenavir or nelfinavir 500 mg/125 mg bid. Infant 14 days-6 mth 16 mg/4 mg/kg or 300 mg/75 mg/m2 bid. Childn 6 mth-18 yr W/o concomitant efavirenz, nevirapine, (fos)amprenavir or nelfinavir 230 mg/57.5 mg/m2 bid. Childn <15 kg 12 mg/3 mg/kg bid, >15-40 kg 10 mg/2.5 mg/kg bid. Concomitant therapy w/ efavirenz, nevirapine, (fos)amprenavir or Nelfinavir 300 mg/75 mg/m2. Childn <15 kg 13 mg/3.25 mg/kg bid, >15-45 kg 11 mg/2.75 mg/kg bid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme). Co-administration w/ drugs highly dependent on CYP3A for clearance. Co-administration w/ potent CYP3A inducers. Co-administration w/ rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, triazolam, orally administered midazolam.
Special Precautions
Patients w/ advanced HIV-1 disease, history of pancreatitis; underlying hepatitis B or C or marked elevations in transaminase prior to treatment. New onset DM, exacerbation of pre-existing DM & hyperglycemia have been reported. Patients w/ underlying structural heart disease, pre-existing conduction system abnormalities, ischemic heart disease or cardiomyopathies. Avoid use in patients w/ congenital long QT syndrome, those w/ hypokalemia & w/ other drugs that prolong QT interval. Immune reconstitution syndrome. Fat redistribution. Patients w/ hemophilia type A & B treated w/ PIs. Cross-resistance. Monitor for increased AST/ALT in patients w/ underlying chronic hepatitis or cirrhosis especially during the 1st several mth of treatment. Perform triglyceride & cholesterol testing prior to initiating & at periodic intervals during therapy. Hepatic dysfunction. Renal impairment. Pregnancy & lactation. Elderly >65 yr. Infant <14 days.
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain, dyspepsia, flatulence, dysphasia; asthenia; headache; insomnia, depression; rash.
Drug Interactions
Increased plasma conc w/ agents that are primarily metabolized by CYP3A. May decrease plasma conc w/ CYP3A inducers. Increased conc of tenofovir, amprenavir, indinavir, nelfinavir, saquinavir, maraviroc, antiarrhythmics (amiodarone, bepridil, systemic lidocaine & quinidine), anticancer agents (vincristine & vinblastine), trazodone, clarithromycin, ketoconazole, itraconazole, rifabutin, midazolam, dihydropiridine Ca channel blockers, sildenafil, tadalafil, vardenafil, atorvastatin, rosuvastatin, immunosuppressants (cyclosporine, tacrolimus, rapamycin), fluticasone. Decreased conc of abacavir, zidovudine, phenytoin, bupropion, hydroxybupropion, voriconazole, atovaquone, methadone, ethinyl estradiol. May produce disulfiram-like reactions w/ disulfiram or other drugs that produce this reaction (eg, metronidazole). Lopinavir: Decreased conc w/ NNRTIs (eg, efavirenz, nevirapine), HIV-1 PI (amprenavir, fosamprenavir/ritonavir, ritonavir, nelpinavir, tipranavir), carbamazepine, phenobarb, rifampin, dexamethasone. Increased conc w/ NNRI (eg, delavirdine).
MIMS Class
Antivirals
ATC Classification
J05AR10 - lopinavir and ritonavir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Ritocom FC tab
Packing/Price
120's
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