Fenofibrate Tablets

Mechanism

Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPAR-α), which increases lipoprotein lipase activity, enhances fatty acid oxidation, and reduces triglyceride-rich lipoproteins.

Pharmacodynamics

It significantly reduces triglycerides and VLDL levels while modestly increasing HDL cholesterol, improving overall lipid metabolism and reducing cardiovascular risk.

Pharamcokinetics

• Absorption: Maximum plasma concentrations (C_max) occur within 4 to 5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any given individual.
• Distribution: Fenofibric acid is strongly bound to plasma albumin (more than 99%).
• Plasma half-life: The plasma elimination half-life of fenofibric acid is approximately 20 hours.
• Protein Binding: ~99%
• Metabolism: Converted to active metabolite (fenofibric acid)
• Half-life: ~20 hours
• Excretion: Mainly via urine (~60%), rest via feces

Side Effects

• Abdominal pain
• Headache
• Muscle pain (myopathy)
• Nausea
• Elevated liver enzymes

Contraindication

• Severe liver disease
• Severe renal impairment
• Gallbladder disease
• Hypersensitivity to fenofibrate

Interaction

• Oral anticoagulants (enhanced effect):Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding.It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring. Therefore, this combination is not recommended
• HMG-CoA reductase inhibitors and other fibrates: The risk of serious muscle toxicity I increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity.
• Cyclosporine: Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

Warning and Precautions

This has been prescribed for the patient's specific condition. It may be dangerous to any other person.

• Monitor liver and renal function
• Risk of muscle toxicity
• Use cautiously in renal impairment
• Periodic lipid profile monitoring required

Dosage

As directed by the Physician.