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Apo-fenofibrate 100mg

Fenofibrate Capsules 100mg

Apo-feno-micro 200mg

Fenofibrate Capsules 200mg

Lipid Metabolism Regulator

 

PHARMACOLOGY

Fenofibrate lowers elevated serum lipids by decreasing the low-density lipoprotein (LDL) fraction rich in cholesterol and the very low-density lipoprotein (VLDL) fraction rich in triglycerides. In addition, fenofibrate increases the high-density lipoprotein (HDL) cholesterol fraction.

 

Fenofibrate appears to have a greater depressant effect on the very low density lipoproteins (VLDL) than on the low density lipoproteins (LDL). Therapeutic doses of fenofibrate produce variable elevations of HDL cholesterol, a reduction in the content of the total low density lipoproteins cholesterol, and a substantial reduction in the triglyceride content of very low density lipoproteins.

 

The mechanism of action of fenofibrate has not been definitely established. Work carried out to date suggests that fenofibrate:

- enhances the liver elimination of cholesterol as bile salts,

- inhibits the biosynthesis of triglycerides and enhances the catabolism of VLDL by increasing the activity of lipoprotein lipase,

- has an inhibitory effect on the biosynthesis of cholesterol by modulating the activity of HMG-CoA reductase.

 

After oral administration with food, fenofibrate is rapidly hydrolyzed into fenofibric acid, the active metabolite. Fenofibrate's absorption is low and variable when the product is administered under fasting conditions. Fenofibrate's absorption is increased when the compound is given with food. In man, it is mainly excreted through the kidney. Half-life is about 20 hours. In patients with severe renal failure, significant accumulation was observed with a large increase in the half-life. Therefore, the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance.

 

The APO-FENO-MICRO formulation of fenofibrate offers in the order of 33% greater bioavailability than the APO-FENOFIBRATE formulation of fenofibrate. Thus, a 200mg capsule of the APO-FENO-MICRO formulation of fenofibrate achieves equivalent plasma levels to a single dose of three 100mg capsules of the APO-FENOFIBRATE formulation. In comparison with the APO-FENOFIBRATE formulation, the absorption of APO-FENO-MICRO is less influenced by fat content of the diet.

 

INDICATIONS

APO-FENOFIBRATE (fenofibrate) and APO-FENO-MICRO (fenofibrate) are indicated as an adjunct to diet and other therapeutic measures for:

 

1. Treatment of patients with hypercholesterolemia, Fredrickson classification Type IIa and IIb mixed hyperlipidemias, to regulate lipid levels (reduce serum triglycerides and LDL cholesterol levels and increase HDL cholesterol).

2. Treatment of adult patients with very high serum triglyceride levels, Fredrickson classification Type IV and Type V hyperlipidemias, who are at a high risk of sequelae and complications (i.e. pancreatitis) from their hyperlipidemia.

 

APO-FENOFIBRATE and APO-FENO-MICRO alone may not be adequate therapy in some patients with familial combined hyperlipidemia with Type Ilb and Type IV hyperlipoproteinemia.

 

Initial therapy for hyperlipidemia should include a specific diet (at least an equivalent of the American Heart Association [AHA] Step 1 diet), weight reduction, and an exercise program; and for patients with diabetes mellitus, good diabetic control.

 

ADVERSE REACTIONS

Clinical adverse effects of fenofibrate therapy have been reported at an incidence between 2 and 15 percent with a mean of 6.3% in European trials of less than 12 months duration. In longer term studies, the incidence was between 7 and 14% with a mean of 11.3%. The most frequently reported adverse effects include:

 

Gastrointestinal: epigastric distress, flatulence, abdominal pain, nausea, diarrhea, constipation.

Dermatologic: erythema, pruritus, urticaria.

Musculoskeletal: muscle pain and weakness, arthralgia.

Central Nervous System: headache, dizziness, insomnia.

Miscellaneous: decreased libido, hair loss, weight loss.

 

WARNINGS

Pediatric Use: Limited experience is available in children and adolescents, at the dose of 5mg/kg/day, non-micronized formulation. However, safety and effectiveness have not been established in this sub-population.

 

Use in Pregnancy: Strict birth control procedures must be exercised by women of childbearing potential. If pregnancy occurs despite birth control procedures, APO-FENOFIBRATE or APO-FENO-MICRO should be discontinued. Women who are planning pregnancy should discontinue fenofibrate several months prior to conception.

 

Nursing Mothers: In the absence of information concerning the presence of fenofibrate in human breast milk, APO-FENOFIBRATE or APO-FENO- MICRO should not be used by nursing mothers.

 

Cholelithiasis: Fenofibrate may increase cholesterol excretion into the bile, and may lead to cholelithiasis. If cholelithiasis is suspected, gall-bladder studies are indicated. APO-FENOFIBRATE or APO-FENO-MICRO should be discontinued if gallstones are found.

 

Since a relationship between reduction of mortality from coronary artery disease and total mortality has not been established, APO-FENOFIBRATE and APO-FENO-MICRO should be administered only to those patients described in INDICATIONS. If a significant serum lipid response is not obtained in three months, fenofibrate products should be discontinued. If APO-FENOFIBRATE or APO-FENO-MICRO is chosen for treatment, the prescribing physician should discuss the proposed therapy and inform the patient of the expected benefits and potential risks which may be associated with long- term administration (see PRECAUTIONS).

 

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