Ritocom

Ritocom

lopinavir + ritonavir

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Per 100/25 mg FC tab Lopinavir 100 mg, ritonavir 25 mg. Per 200/50 mg FC tab Lopinavir 200 mg, ritonavir 50 mg
Indications/Uses
2nd line treatment of HIV-infection in combination w/ other antiretroviral agents.
Dosage/Direction for Use
Adult Therapy-naive patient 400 mg/100 mg (2 tab of 200/50 mg tab) twice daily or 800 mg/200 mg (4 tab of 200/50 mg tab) once daily. Therapy-experienced patient 400 mg/100 mg (2 tab of 200/50 mg tab) twice daily. Childn BSA ≥1.4 m2 4 tab of 100/25 mg, >0.9-<1.4 m2 3 tab of 100/25 mg, ≥0.6-<0.9 m2 2 tab of 100/25 mg. Wt >35 kg 4 tab of 100/25 mg, >25-35 kg 3 tab of 100/25 mg, 15-25 kg 2 tab of 100/25 mg. Concomitant use w/ efavirenz, nevirapine, amprenavir or nelfinavir Adult 400 mg/100 mg twice daily, may be increased to 533 mg/133 mg twice daily. Childn BSA ≥1.7 m2 5 tab of 100/25 mg, ≥1.2-<1.7 m2 4 tab of 100/25 mg, >0.8-<1.2 m2 3 tab of 100/25 mg, ≥0.6-<0.8 m2 2 tab of 100/25 mg. Wt >45 kg 5 tab of 100/25 mg, >30 kg-45 kg 4 tab of 100/25 mg, >20-30 kg 3 tab of 100/25 mg, 15-30 kg 2 tab of 100/25 mg. All doses are given twice daily.
Administration
May be taken with or without food: Swallow whole, do not chew/break/crush.
Contraindications
Hypersensitivity. Co-administration w/ alfuzosin HCl; ranolazine; dronadrone; colchicine in patients w/ renal &/or hepatic impairment; astemizole, terfenadine; blonanserin, lurasidone, pimozide; midazolam, triazolam; ergotamine, dihydroergotamine, ergonovine, methylergonovine; cisapride; St. John's wort; lovastatin-simvastatin; salmeterol; pimozide; sildenafil only when used for the treatment of pulmonary arterial HTN. Severe hepatic insufficiency.
Special Precautions
Concomitant use w/ rifampin, quetiapine, corticosteroids (eg, fluticasone, budesonide), PDE5 inhibitors (eg, avanafil, tadalafil or vardenafil), HMG-CoA reductase inhibitor (eg, rosuvastatin), tipranavir. New onset DM, exacerbation of preexisting DM & hyperglycemia in HIV-infected patients receiving PI therapy. Monitor blood glucose; increased AST/ALT in patients w/ underlying chronic hepatitis or cirrhosis especially during the 1st several mth of treatment. Increased risk of elevated triglycerides & pancreatitis in patients w/ advanced HIV disease & history of pancreatitis. Patients w/ underlying hepatitis B or C or marked elevations in transaminase prior to treatment. Cross-resistance. Increased bleeding including spontaneous skin hematomas & hemarthrosis in patients w/ hemophilia type A & B treated w/ PIs. Patients w/ underlying structural heart disease, preexisting conduction system abnormalities, or in those receiving drugs known to prolong PR interval eg, verapamil or atazanavir. Fat redistribution. Increased conc of total cholesterol & triglycerides. Perform triglyceride & cholesterol testing prior to initiating & at periodic intervals during therapy. Immune reconstitution syndrome. Autoimmune disorders including Grave's disease, polymyositis & Guillain-Barre syndrome may also occur many mth after initiation of treatment. Osteonecrosis in patients w/ advanced HIV-disease &/or long-term exposure. Patient should seek medical advice if experiencing joint aches, pain, stiffness or difficulty in movement. Hepatic dysfunction. Childn <6 yr. Elderly.
Adverse Reactions
Diarrhea, nausea, vomiting, hypertriglyceridemia, hypercholesterolemia, dysgeusia (in childn).
Drug Interactions
Increased plasma conc w/ drugs that are primarily metabolized by CYP3A (eg, dihydropyridine Ca channel blockers (felodipine, nifedipine, nicardipine), HMG-CoA reductase inhibitors, immunosuppressants & sildenafil). Potential to reduce plasma conc of zidovudine & abacavir. Increased conc of tenofovir, rilpivirine, indinavir, saquinavir, maraviroc, fentanyl, antiarrhythmics (amiodarone, bepridil, systemic lidocaine & quinidine), digoxin, anticancer agents (eg, dasatinib, nilotinib, vincristine & vinblastine), trazodone, ketoconazole, itraconazole, colchicine, lovastatin, simvastatin, immunosuppressants (cyclosporin, tacrolimus, rapamycin), vasodilating agents (bosentan). Increased CPK, myalgia, myositis & rarely rhabdomyolysis in combination w/ NRTIs. Decreased plasma conc of etravirine, bupropion, atovaquone, methadone, OCs (ethinyl estradiol). Reduced steady-state exposure of telaprevir, boceprevir, phenytoin, lamotrigine. May affect conc of warfarin. Increased risk of bleeding w/ rivaroxaban. Increased AUC of clarithromycin, atorvastatin. Increased exposure of avanafil, . Reduced plasma conc w/ St. John's wort. Lopinavir: Decreased conc w/ NNRTIs (eg, efavirenz, nevirapine), PIs (eg, amprenavir, fosamprenavir, nelfinavir, nelfinavir, anticonvulsants (phenobarb, phenytoin, carbamazepine), rifampin, dexamethasone. Increased AUC & Cmin w/ additional 100 mg ritonavir. Increased conc w/ delavirdine. Combination w/ bedaquiline.
MIMS Class
ATC Classification
J05AR10 - lopinavir and ritonavir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Ritocom FC tab 100 mg/25 mg
Packing/Price
1 × 120's
Form
Ritocom FC tab 200 mg/50 mg
Packing/Price
1 × 120's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in