Flezinox 150

INDICATIONS:

Primary hypercholesterolemia or mixed dyslipidemia: Flezinox 150 is indicated as an adjunct to diet in patients with primary hypercholesterolemia or mixed dyslipidemia with elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-C), triglycerides (TG) and apolopoprotein B (ApoB); and to increase high-density lipoprotein cholesterol (HDL-C).

Severe hypertriglyceridemia: Flezinox 150 is also indicated as an adjunct to diet in adults with severe hypertriglyceridemia. Improvement of glycemic control in diabetic patients with fasting microchloasma usually does not require pharmacological intervention. Markedly elevated serum triglyceride levels (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The efficacy of fenofibrate therapy in reducing this risk has not been adequately studied.

Important Limitation of Use: In a large randomized controlled trial in patients with type 2 diabetes, fenofibrate at a dose equivalent to 150 mg did not reduce the incidence of coronary heart disease and mortality.

DOSAGE AND ADMINISTRATION:

Directions for use:

Take Flezinox capsules with meals to optimize absorption.

Patients should maintain an appropriate lipid-lowering diet before and during Flezinox therapy.

Initial treatment of dyslipidemia is specific dietary therapy. Overweight and excessive alcohol consumption may be important factors in hypertriglyceridemia and should be addressed before initiating drug therapy. Exercise may be an important adjunctive measure. Contributing diseases to hyperlipidemia such as hypothyroidism or diabetes should be identified and treated. Estrogen therapy, thiazide diuretics and beta-blockers may be strongly associated with hypertriglyceridemia, especially in patients with familial hypertriglyceridemia. In these cases, discontinuation of the specific causative agent may reduce the need for drug therapy for hypertriglyceridemia.

Periodically determine blood lipid levels to establish the lowest effective dose. Treatment should be discontinued if the patient does not respond adequately after two months of treatment at the maximum recommended dose of 150 mg/day. Consider reducing the dose of fenofibrate if lipid levels fall significantly below the target level.

Dosage:

Primary hypercholesterolemia or mixed dyslipidemia: 150 mg fenofibrate once daily.

Severe hypertriglyceridemia: Initial dose of 50 to 150 mg fenofibrate/day. Dosage should be adjusted according to individual patient response and should be adjusted after lipid levels are determined over a period of 4 to 8 weeks.

The maximum dose is 150 mg fenofibrate/day.
Patients with renal impairment: Patients with mild to moderate renal impairment, use a starting dose of 50 mg/day, increase the dose only after assessing the impact on the kidney and the effect of the dose on lipid levels. The drug should not be used in patients with severe renal impairment. Elderly: Use the same dose as prescribed for patients with renal impairment.

CONTRAINDICATIONS:
Hypersensitivity to fenofibrate, fenofibric acid or any of the excipients
Patients with severe renal impairment including patients undergoing hemodialysis
Patients with active liver disease including primary biliary cirrhosis and unexplained persistent liver function abnormalities
Patients with pre-existing gallbladder disease.
Breastfeeding women.