Pharmacology: Fenofibrate is phenoxyisobutyric acid. With clofibrate and other fibrate derivatives is used as lipid regulatory by reducing total plasma cholesterol and triglyceride in healthy subjects and patients with hyperlipoproteinemia. The main action of fenofibrate is to increase lipoprotein catabolism in patients with triglyceride-rich lipoprotein by increasing lipase lipoprotein activity.
Treatment of type IIa, IIb, III and IV hyperlipoproteinemias in conjunction with dietary modification.
Adults: Initial Dose: 100 mg 3 times a day or 300 mg/day as a single dose.
If after strict cholesterol diet the concentration of cholesterol stays at >4 g/L, dose can be increased to 100 mg 4 times daily.
Initial dose should be maintained until cholesterol level gets back to normal. If cholesterol level stabilized, dosage of 100 mg twice daily can be given provided that the cholesterol level is checked every 3 months. If there is a new increase in the plasma cholesterol concentration, dose should go back to initial dose of 100 mg, 3 times daily.
Hypersensitivity to fenofibrate; patients with severe liver and renal dysfunction; gallbladder disease; pregnancy and lactation; children.
For the first year of therapy, serum transaminase should be monitored periodically, every 3 months. Therapy should be discontinued and if there is an increase of SGPT concentration >100 unit/L.
Combination therapy of hepatotoxic substances eg, MAOI is not recommended.
If 3 months after therapy, the reduction of serum concentration of lipid is not satisfactory, other therapeutic agents should be considered.
Contraindicated during pregnancy and lactation.
In general, side effects are mild and rarely reported. In prolonged therapy, the following side effects have been reported: Gastrointestinal disturbance (about 5%); headache (about 1%); muscular spasm (about 1%); transient elevation of transaminases and creatinine phosphokinase; skin allergic reactions; fatigue and vertigo.
The effect of oral anticoagulants is potentiated by fenofibrate. This increases the risk of hemorrhage through the displacement of their binding with plasma protein. Therefore, initial dose therapy with fenofibrate should be reduced to 1/3 of the normal dose.
Adjustment of oral anticoagulant dose according to prothrombin time during therapy by fenofibrate and 8 days after its interruption.
Store between 25-30°C, in a dry place. Protect from light.
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.