Each capsule contains Fenofibrate 200 mg.
Pharmacology: Pharmacokinetics: Fenofibrate is readily absorbed from the gastrointestinal tract when taken with food; absorption may be reduced if fenofibrate is given on an empty stomach, although this depends on the formulation. It is rapidly hydrolysed to its active metabolite fenofibric acid which is about 99% bound to plasma albumin. The plasma elimination half-life is about 20 hours. Fenofibric acid is excreted mainly in the urine, mainly as the glucoronide conjugate, but also as reduced form of fenofibric acid and its glucoronide. It is not removed by haemodialysis.
It is used to reduce low-density lipoprotein (LDL)-cholesterol, total cholesterol, triglycerides and apolipoprotein B, and to increase high-density lipoprotein (HDL)-cholesterol, in the management of hyperlipidaemias, including type IIa, type IIb, type II, type IV and type V hyperlipoproteinaemias.
Non-micronised formulations may also be available and are given in an initial dose of 200 to 300 mg in daily divided doses, adjusted according to response to between 200 and 400 mg daily; 100 mg of non-micronised fenofibrate is therapeutically equivalent to 67 mg of the standard micronised form. Or as prescribed by the physician.
It is contraindicated if creatinine clearance is below 15 mL/minute unless the patient is on dialysis and with a known hypersensitivity to any component of this product.
Fenofibrate should not be given to patients with severe hepatic impairment or significant liver disease, gallstones or gallbladder disorders or hypoalbuminaemic states such as nephrotic syndrome. It should be used with caution in renal impairment.
The commonest adverse effects of fenofibrate therapy are gastrointestinal disturbances including anorexia, nausea and gastric discomfort. Other adverse effects reported to occur less frequently include headache, dizziness, vertigo, fatigue, skin rashes, pruritus, photosensitivity, alopecia, impotence, anaemia, leucopenia, and thrombocytopenia. Raised serum-aminotransferase concentrations have occasionally been reported. Elevated creatine phosphokinase concentrations during fenofibrate therapy may be at increased risk. Fenofibrate should not be given with statins in patients with risk factors for myopathy. Bozafibrate may increase the lithogenic index and there have been isolated reports of gallstones, although the risk from fibrate as class is unclear.
Fenofibrate and other fibrates are highly protein-bound and may displace other drugs from protein binding sites. Interactions may also occur through changes in the activity of cytochrome P450 iso-enzymes, particularly CYP3A4.
Store at temperatures not exceeding 30°C.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.