Fenoglide
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Uses
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Fenoglide is 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 hyperlipidemia or mixed dyslipidemia. 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.
Fenoglide is also indicated as adjunctive therapy to diet for treatment of adult patients with 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.
Fenofibrate 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(5.6).]
Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Fenoglide therapy on reducing this risk has not been adequately studied.
Drug therapy is not indicated for patients 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 these patients from those with elevated VLDL.2
History
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Other Information
Fenoglide (fenofibrate) Tablets, is 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-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:
The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions.
Inactive Ingredients: Each tablet contains lactose monohydrate, NF; Polyethylene Glycol 6000, NF; Poloxamer 188, NF; and magnesium stearate, NF.
Sources
Fenoglide Manufacturers
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Physicians Total Care, Inc.
![Fenoglide (Fenofibrate) Tablet [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fenoglide | Physicians Total Care, Inc.
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2.1 Hyperlipidemia and Mixed DyslipidemiaThe initial dose of Fenoglide is 120 mg per day.
2.2 HypertriglyceridemiaThe 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.
2.3 Renally Impaired PatientsTreatment with Fenoglide should be initiated at a dose of 40 mg/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 Fenoglide should be avoided in patients with severely impaired renal function.
2.4 Elderly PatientsDose selection for the elderly should be made on the basis of renal function. [See Use in Specific Populations (8.5).]
2.5 General Dosing InformationTo increase absorption of Fenoglide, take with food.
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Shore Therapeutics, Inc
Fenoglide | Shore Therapeutics, Inc
2.1 Hyperlipidemia and Mixed DyslipidemiaThe initial dose of Fenoglide is 120 mg per day.
2.2 HypertriglyceridemiaThe 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.
2.3 Renally Impaired PatientsTreatment with Fenoglide should be initiated at a dose of 40 mg/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 Fenoglide should be avoided in patients with severely impaired renal function.
2.4 Elderly PatientsDose selection for the elderly should be made on the basis of renal function. [See Use in Specific Populations (8.5).]
2.5 General Dosing InformationTo increase absorption of Fenoglide, take with food.
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Santarus, Inc.
Fenoglide | Santarus, Inc.
2.1 General ConsiderationsFENOGLIDE tablets should be given with food to optimize the absorption of the medicine. Patients should be advised to swallow FENOGLIDE 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 FENOGLIDE 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 DyslipidemiaThe initial dose of FENOGLIDE is 120 mg per day.
2.3 Severe HypertriglyceridemiaThe 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 FunctionTreatment with FENOGLIDE 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 FENOGLIDE should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsDose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].
![Fenoglide (Fenofibrate) Tablet [Shore Therapeutics, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b38489c0-ee7b-11df-b958-0002a5d5c51b&name=fenoglide-figure-2.jpg)
![Fenoglide (Fenofibrate) Tablet [Santarus, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=35e89d4e-45cf-4374-bf93-fca8d40d783b&name=fen01-0004-02.jpg)
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