RVP

Drug Catalog - Product Detail

FENOFIBRATE TAB 160MG 90CT

NDC Mfr Size Str Form
63304-0901-90 SUN PHARMACEUTICALS 90 160MG TABLET
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Fenofibrate tablets are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methylpropanoic acid, 1-methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate;USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder. Chemical Structure Inactive Ingredients Inactive Ingredients: Each tablet contains colloidal silicon dioxide, crospovidone, lecithin (soya), microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and xanthan gum.
How Supplied
HOW SUPPLIED Fenofibrate tablets 160 mg are white to off-white, oval-shaped, biconvex, film-coated tablets debossed with "RX 901" on one side and plain on the other side. NDC 63304-901-90 Bottles of 90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Protect from moisture. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Indications & Usage
INDICATIONS AND USAGE Treatment of Hypercholesterolemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines , below). Treatment of Hypertriglyceridemia Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate tablets therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia 2 . The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS ). Fredrickson Classification of Hyperlipoproteinemias Type Lipoprotein Elevated Lipid Elevation Major Minor C = cholesterol TG = triglycerides LDL = low density lipoprotein VLDL = very low density lipoprotein IDL = intermediate density lipoprotein I (rare) chylomicrons TG ↑↔C IIa LDL C - IIb LDL, VLDL C TG III (rare) IDL C, TG - IV VLDL TG ↑↔C V (rare) Chylomicrons, VLDL TG ↑↔ C NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/ dL) LDL Level at Which Consider Drug Therapy (mg/ dL) Risk Category LDL Goal (mg/dL) CHD CHD = coronary heart disease or CHD risk equivalents (10-year risk > 20%) < 100 ≥ 100 ≥ 130 (100-129: drug optional) Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. 2+ Risk Factors (10-year risk ≤ 20%) < 130 ≥ 130 10-year risk 10%- 20%: ≥ 130 10-year risk < 10%: ≥ 160 0 to 1 Risk Factor Almost all people with 0 to 1 risk factor have 10-year risk < 10 %; thus, 10-year risk assessment in people with 0 to 1 risk factor is not necessary. < 160 ≥ 160 ≥ 190 (160-189: LDL-lowering drug optional) After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.
Dosage and Administration
DOSAGE AND ADMINISTRATION Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablets, and should continue this diet during treatment with fenofibrate tablets. Fenofibrate tablets should be given with meals, thereby optimizing the bioavailability of the medication. For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate tablets is 160 mg per day. For adult patients with hypertriglyceridemia, the initial dose is 54 to 160 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg per day. Treatment with fenofibrate tablets should be initiated at a dose of 54 mg/day in patients having impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 54 mg/day. Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate tablets if lipid levels fall significantly below the targeted range.