Composition:

Each capsule contains Fenofibrate BP (Micronized) 200 mg.

Pharmacology:

Fenofibrate is a fibric acid derivative. Fenofibrate is rapidly hydrolyzed, after oral ingestion into its pharmacologically active form fenofibric acid. Fenofibrate reduces total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. In addition, fenofibrate increases high density lipoprotein (HDL) and apolipoproteins apo AI and AII. The effects of Fenofibrate seen in human hepatocyte cultures by the activation of peroxisome proliferator activated receptor α (PPARα). Fenofibrate also reduces serum uric acid levels in hyperuricemic by increasing the urinary excretion of uric acid.

Indications:

Tigicon is indicated for treatment of hyperlipidemias of type IIa, IIb, III, IV and IV in patients who have not responded adequately to diet and other appropriate measures.

Dosage and administration:

The dose is one capsule per day. Fenofibrate capsule should be taken after meal.

Contraindications:

Severe liver disease or gallstone and severe renal impairment, hypersensitivity to Fenofibrate.

Side effect:

Nausea, anorexia, gastric pain, pruritus, urticaria, headache, dizziness, vertigo and fatigue.

Precautions:

Special care should be needed in patients with renal disease. Discontinuation of the drug is necessary if creatinine kinase concentration increases significantly.

Special population:

Pediatrics: Fenofibrate has not been investigated in adequate and well controlled trials in pediatric patients.

Renal insufficiency: the dosage of Fenofibrate should be minimized in patients who have severe renal impairment.

Pregnancy and nursing mothers: Fenofibrate is contraindicated during pregnancy and nursing mothers.

Drug Interaction:

Fenofibrate potentiates the action of oral anticoagulants. In patients receiving oral anticoagulant therapy the dose should be reduced by one third on starting Fenofibrate. Fenofibrate should not be used in combination with perhexiline maleate or with monoamine oxidase inhibitors.

Storage:

Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.

Packing:

Each box containing 3x10’s capsules in blister pack.