Fenofibrate

Fenofibrate is a medicine used to treat high cholesterol. This medicine helps by lowering triglycerides and bad cholesterol (LDL), while at the same time raising the levels of good cholesterol (HDL). Lowering cholesterol levels reduces the risk of heart attack and stroke.

Fenofibrate is a fibric acid derivative. It lowers plasma triglyceride by activating lipoprotein lipase thus increasing catabolism of VLDL with consequent increase in HDL levels.

• Hyperlipidemia (Type IIa, IIb, III, IV and V): Indicated for patients who have not responded adequately to diet and other appropriate measures.
• High Triglycerides: Used for lowering triglyceride levels.
• High Cholesterol: Used for lowering total cholesterol and LDL cholesterol.

Fibrates

Fibric Acid Derivative

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed after oral ingestion to its pharmacologically active form, fenofibric acid. Fenofibric acid produces reductions in total cholesterol, LDL cholesterol, Apo-lipoprotein B, Total triglycerides and VLDL. In addition, treatment with Fenofibrate results in increases in HDL and apo-proteins apoAI apoAII.

Fenofibrate, a fibric acid derivative, lowers plasma triglyceride by activating lipoprotein lipase thus increasing catabolism of VLDL with consequent increase in HDL levels.

Adult Dose (Oral):

• Hypercholesterolemia, Mixed Dyslipidemia: Tablet: 40-160 mg once daily; Capsule: 200 mg once daily.
• Hypertriglyceridemia: 67-200 mg/day.

Child Dose: Safety and efficacy not established.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Fenofibrate is to be taken empty stomach.

If you miss a dose of Fenofibrate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Increased liver enzymes
• Nausea
• Vomiting
• Flatulence
• Abdominal pain
• Diarrhea
• Headache
• Dizziness
• Fatigue
• Hair loss

Precautions:

• Fenofibrate does not usually affect your ability to drive.
• Take with food.
• Avoid alcohol consumption.
• Your doctor may check your liver function before starting treatment and regularly thereafter.
• Notify your doctor if you are more tired than usual, do not feel hungry, or if you have yellow eyes, skin or dark urine.
• Inform doctor if you experience muscle pain, tenderness, cramps, or weakness (especially with fever).
• Do not discontinue Fenofibrate without consulting your doctor even if you feel better.
• Renal impairment: dose adjustment may be needed; severe renal impairment: not recommended.

Contraindications:

• Hypersensitivity
• Severe hepatic and renal impairment
• Unexplained persistent liver function abnormality and primary biliary cirrhosis
• Preexisting gall bladder disease
• Pregnancy and lactation

Drug Interactions:

• Bile acid sequestrants (colestyramine): Decreased absorption.
• Cyclosporine: May increase risk of nephrotoxicity.
• HMG-CoA reductase inhibitors (simvastatin): Increased risk of muscle toxicity.
• Oral anticoagulants (warfarin): May increase risk of bleeding.

Food Interactions: It is unsafe to consume alcohol with Fenofibrate.

Use in Pregnancy: Fenofibrate may be unsafe; animal studies have shown harmful effects on the developing baby.

Use in Lactation: Fenofibrate is probably unsafe; limited data suggests drug may pass into breastmilk and harm the baby.

Pediatric Use: Safety and efficacy not established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Use with caution; mild-moderate: lower initial dose; severe: contraindicated.

Hepatic Impairment: Use with caution; severe liver disease: not recommended.

Overdose: No specific treatment for overdose; general supportive care indicated.

Storage: Do not store above 30 degree C. Keep away from light and out of reach of children.

Fenofibrate