June 28, 2016
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Fenoglide

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Fenoglide




Indications
Dosage
How Supplied

INDICATIONS

Primary Hypercholesterolemia And Mixed Dyslipidemia

FENOGLIDE is 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.

Severe Hypertriglyceridemia

FENOGLIDE 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 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 FENOGLIDE therapy on reducing this risk has not been adequately studied.

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].

DOSAGE AND ADMINISTRATION

General Considerations

FENOGLIDE 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.

Primary Hypercholesterolemia Or Mixed Dyslipidemia

The initial dose of FENOGLIDE is 120 mg per day.

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.

Impaired Renal Function

Treatment 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 and CLINICAL PHARMACOLOGY].

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

  • 40 mg: White to off-white oval tablets. Debossed “FLO”.
  • 120 mg: White to off-white oval tablets. Debossed “FHI”.

Storage And Handling

FENOGLIDE (fenofibrate) Tablets 40 mg, are white to off-white oval tablets debossed “FLO” on one side and blank on the other side.

Bottle of 90 tablets, NDC 68012-490-90.

Fennoglide (fenofibrate) Tablets 120 mg are white to off-white oval tablets debossed “FHI” on one side and blank on the other side.

Bottle of 90 tablets. NDC 68012-495-90

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Distributed by: Santarus, Inc. San Diego, CA 92130. Revised: Oct 2012

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/14/2016

Indications
Dosage
How Supplied

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