Lipired® Capsule: Each capsule contains micronised Fenofibrate BP 200 mg.
Fenofibric acid, the active metabolite of fenofibrate, lowers plasma triglycerides apparently by inhibiting triglyceride synthesis, resulting in a reduction of VLDL released into the circulation, and also by stimulating the catabolism of triglyceride-rich lipoprotein (i.e., VLDL). Fenofibrate also reduces serum uric acid levels in hyperuricemic and normal individuals by increasing the urinary excretion of uric acid.
PHARMACOKINETIC:
Comparisons of blood level following oral administration of both formulations in healthy volunteers demonstrate that a single capsule containing 67 mg of the “micronised” formulation is bioequivalent to 100 mg of the “non-micronised” formulation. Absorption: Fenofibrate is well absorbed from the gastrointestinal tract and Peak plasma levels of fenofibric acid occur within 6 to 8 hours after administration. The absorption of fenofibrate is increased when administered with food. With micronised fenofibrate, the absorption is increased by approximately 35% under fed as compared to fasting conditions. Distribution: In healthy volunteers, steady-state plasma levels of fenofibric acid were shown to be achieved within 5 days of dosing and did not demonstrate accumulation across time following multiple dose administration. Serum protein binding was approximately 99% in normal and hyperlipidemic subjects. Metabolism: Following oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite, fenofibric acid; no unchanged fenofibrate is detected in plasma. Fenofibric acid is primarily conjugated with glucuronic acid and then excreted in urine. Excretion: After absorption, fenofibrate is mainly excreted in the urine in the form of metabolites, primarily fenofibric acid and fenofibric acid glucuronide. The compound is eliminated with a half-life of 20 hours, allowing once daily administration in a clinical setting.
Fenofibrate (fenofibrate capsules), micronised, is indicated as adjunctive therapy to diet for treatment of hyperlipidemias of Type IIa, IIb, III, IV and V who do not respond adequately to a determined dietary effort or other appropriate measures to control them.
The dose is one 200 mg capsule per day. Dosage should be individualized according to patient response, and should be increased sequentially if necessary following repeat serum triglyceride estimations at 4 to 8 week intervals. Patients should be placed on an appropriate triglyceride-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. Fenofibrate should be given with meals, thereby optimizing the bioavailability of the medication.
Oral Anticoagulants: Caution should be exercised when anticoagulants are given in conjunction with fenofibrate. The dosage of the anticoagulants should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Resins: Since bile acid sequestrants may bind other drugs given concurrently, patients should take fenofibrate at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption. Cyclosporine: Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an.