RVP

Drug Catalog - Product Detail

FENOFIBRATE TABS. TB 120MG 90

NDC Mfr Size Str Form
00378-4391-77 MYLAN 90 120MG TABLET
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PACKAGE FILES

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Generic Name
FENOFIBRATE
Substance Name
FENOFIBRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA204475
Description
11 DESCRIPTION Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 40 mg or 120 mg fenofibrate. The chemical name for fenofibrate is 2-[4-4-chlorobenzoylphenoxy]-2-methylpropanoic acid 1-methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 ClO 4 and the molecular weight is 360.8; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients: Each tablet contains colloidal silicon dioxide, lactose monohydrate, magnesium stearate, polyethylene glycol, polyoxyl 40 hydrogenated castor oil, povidone, pregelatinized starch (corn), silicified microcrystalline cellulose and vitamin E polyethylene glycol succinate. Meets USP Dissolution Test 3. Fenofibrate Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibrate Tablets, USP are available containing 40 mg or 120 mg of fenofibrate, USP. The 40 mg tablets are white, capsule shaped, unscored tablets debossed with M on one side of the tablet and FT1 on the other side. They are available as follows: NDC 0378-4390-77 bottles of 90 tablets The 120 mg tablets are white, capsule shaped, unscored tablets debossed with M on one side of the tablet and FT2 on the other side. They are available as follows: NDC 0378-4391-77 bottles of 90 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Fenofibrate tablets are a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: • to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia. ( 1.1 ) • to treat adult patients with severe hypertriglyceridemia. ( 1.2 ) Important Limitation of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. ( 5.1 ) 1.1 Primary Hypercholesterolemia and Mixed Dyslipidemia Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 1.2 Severe Hypertriglyceridemia Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. 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. 1.3 Important Limitations of Use Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) ] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Primary hypercholesterolemia or mixed dyslipidemia: 120 mg per day. ( 2.2 ) • Severe hypertriglyceridemia: 40 to 120 mg per day; the dose should be adjusted according to patient response. ( 2.3 ) • Renally impaired patients: Initial dose of 40 mg per day; the dose should be increased according to the effect on renal function and lipid levels. ( 2.4 ) • Geriatric patients: Select dose on the basis of renal function. ( 2.5 ) To increase absorption of fenofibrate tablets, take with food. ( 2.1 ) 2.1 General Considerations Fenofibrate tablets should be given with food to optimize the absorption of the medicine. Patients should be advised to swallow fenofibrate tablets whole. Do not crush, dissolve or chew tablets. 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. 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. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 120 mg once daily. 2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia The initial dose of fenofibrate tablets is 120 mg per day. 2.3 Severe Hypertriglyceridemia The initial dose is 40 to 120 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 120 mg per day. 2.4 Impaired Renal Function Treatment with fenofibrate tablets should be initiated at a dose of 40 mg per day in patients with mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 2.5 Geriatric Patients Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5) ] .