Lipofen
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Uses
LIPOFEN is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
LIPOFEN is 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.
Fenofibrate at a dose equivalent to 150 mg of LIPOFEN was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions(5.1)].
History
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Other Information
LIPOFEN® (fenofibrate capsules, USP), is a lipid regulating agent available as hard gelatin capsules for oral administration. Each hard gelatin capsule contains 50 or 150 mg of fenofibrate, USP. 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 C20H21O4C1 and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82oC. Fenofibrate is a white solid which is stable under ordinary conditions.
LIPOFEN (fenofibrate capsules, USP) meets USP Dissolution Test 2.
Inactive Ingredients: Each hard gelatin capsule contains Gelucire 44/14 (lauroyl macrogol glyceride type 1500), polyethylene glycol 20,000, polyethylene glycol 8000, hydroxypropylcellulose, sodium starch glycolate, gelatin, titanium dioxide, shellac, propylene glycol, may also contain black iron oxide, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, D&C Yellow #10.
Sources
Lipofen Manufacturers
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Kowa Pharmaceuticals America Inc.
![Lipofen (Fenofibrate) Capsule [Kowa Pharmaceuticals America Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lipofen | Kowa Pharmaceuticals America Inc.
2.1 General ConsiderationsLIPOFEN capsules should be given with meals thereby optimizing the absorption of the medication.
Patients should be advised to swallow LIPOFEN capsules whole. Do not open, crush, dissolve or chew capsules.
Patients should be placed on an appropriate lipid-lowering diet before receiving LIPOFEN, and should continue this diet during treatment with LIPOFEN.
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.
Periodic determination of serum lipids should be obtained during initial therapy in order to establish the lowest effective dose of LIPOFEN. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.
Consideration should be given to reducing the dosage of LIPOFEN if lipid levels fall significantly below the targeted range.
2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia:The dose of LIPOFEN is 150 mg once daily.
2.3 Severe Hypertriglyceridemia:The initial dose is 50 to 150 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determination at 4 to 8 week intervals.
The maximum dose of LIPOFEN is 150 mg once daily.
2.4 Impaired Renal FunctionIn patients with mild-to-moderate renal impairment, treatment with LIPOFEN should be initiated at a dose of 50 mg per day, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of LIPOFEN 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) and Clinical Pharmacology (12.3)].
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