Trilipix Modified Release Capsules 135mg

CAPSULE, DELAYED RELEASE PELLETS

**Posology and method of administration** Patients should be placed on an appropriate lipid-lowering diet before receiving Trilipix as monotherapy or co-administered with a statin, and should continue this diet during treatment. Trilipix modified release capsules can be taken without regard to meals. Serum lipids should be monitored periodically. The maximum dose is 135 mg once daily. Adults - Co-administration therapy with statins for the treatment of mixed dyslipidemia: Trilipix 135 mg may be co-administered with an HMG-CoA reductase inhibitor (statin) in patients with mixed dyslipidemia. For convenience, the daily dose of Trilipix may be taken at the same time as a statin, according to the dosing recommendations for each medication. Coadministration with the maximum dose of a statin has not been evaluated in clinical studies and should be avoided unless the benefits are expected to outweigh the risks. - Severe Hypertriglyceridemia The initial dose of Trilipix is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily. - Primary Hyperlipidemia or Mixed Dyslipidemia The dose of Trilipix is 135 mg once daily. Elderly Dose selection for the elderly should be made on the basis of renal function. Renal impairment Treatment with Trilipix should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment (creatinine clearance 30–80ml/min) and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of Trilipix should be avoided in patients with severely impaired renal function. Hepatic impairment Patients with hepatic disease have not been studied. Children Trilipix is not recommended for use in children below age 18 due to a lack of data on safety and efficacy. General Considerations for Treatment Fenofibrate at a dose equivalent to 135mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus. Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy. Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.