Drug Catalog - Product Detail
Fenofibrate Tab 160 MG 500 EA
NDC | Mfr | Size | Str | Form |
---|---|---|---|---|
69367-0254-05 | WESTMINSTER PHARMACEUTICALS | 500 | 160MG | TABLET |
PACKAGE FILES
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-01.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-01.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-02.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-02.jpg)
![<img src='https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-03.jpg'> Package Image](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a97ebf51-4f68-4426-9958-5c59f91b1d47&name=fenofibrate-03.jpg)
Generic Name
FENOFIBRATE
Substance Name
FENOFIBRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207803
Description
11 DESCRIPTION Fenofibrate tablets USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; Fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each 54 mg and 160 mg fenofibrate tablet USP contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lecithin (soy), microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablets meet USP Dissolution Test 2. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibrate tablets USP are available in two strengths: 54 mg – White to off white, oval-shaped, film-coated, unscored tablet, debossed with "CL 25" on one side and blank on the other side. Available in bottles of 90 (NDC 69367-257-09). 160 mg - White to off white, oval-shaped, film-coated, unscored tablet, debossed with "CL 26" on one side and blank on the other side. Available in bottles of 90 (NDC 69367-254-09) and 500 (NDC 69367-254-05). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Indications & Usage
1 INDICATIONS AND USAGE Fenofibrate tablets are a peroxisome proliferator-activated receptor (PPAR) alpha agonist 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 ). For treatment of adult patients with severe hypertriglyceridemia ( 1.2 ). Limitations 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 or 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 and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (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 obviate 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 therapy on reducing this risk has not been adequately studied. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) ] .
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily ( 2.2 ). Severe hypertriglyceridemia: Initial dose of 54 mg to 160 mg once daily. Maximum dose is 160 mg ( 2.3 ). Renally impaired patients: Initial dose of 54 mg once daily ( 2.4 ). Geriatric patients: Select the dose on the basis of renal function ( 2.5 ). Should be given with meals ( 2.1 ). 2.1 General Considerations 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. 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 160 mg once daily. 2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia The initial dose of fenofibrate tablet is 160 mg once daily. 2.3 Severe 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 once daily. 2.4 Impaired Renal Function Treatment with fenofibrate tablets should be initiated at a dose of 54 mg per day in patients having 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) ] .