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Fibricor

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Fibricor

Indications
Dosage
How Supplied

INDICATIONS

Severe Hypertriglyceridemia

FIBRICOR is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia ( ≥ 500 mg/dL). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Markedly elevated levels of serum triglycerides > 2000 mg/dL may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Primary Hypercholesterolemia Or Mixed Dyslipidemia

FIBRICOR 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 cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Important Limitations Of Use

Fenofibrate at a dose equivalent to 105 mg of FIBRICOR 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

FIBRICOR can be given without regard to meals. Patients should be advised to swallow FIBRICOR tablets whole. Do not crush, dissolve or chew tablets.

Patients should be placed on an appropriate lipid-lowering diet before receiving FIBRICOR and should continue this diet during treatment with fenofibric acid.

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 FIBRICOR. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 105 mg per day.

Consideration should be given to reducing the dosage of FIBRICOR if lipid levels fall significantly below the targeted range.

Severe Hypertriglyceridemia

The initial dose is 35 to 105 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 105 mg once daily.

Primary Hypercholesterolemia Or Mixed Dyslipidemia

The dose of FIBRICOR is 105 mg per day.

Impaired Renal Function

In patients with mild-to-moderate renal impairment, treatment with FIBRICOR should be initiated at a dose of 35 mg once daily, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of FIBRICOR 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 and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

  • 35-mg: White, round tablets. Debossed “AR 787”.
  • 105-mg: White, modified oval tablets. Debossed “AR 788”.

Storage And Handling

FIBRICOR® (fenofibric acid) Tablets 35 mg, are white, round tablets, debossed “AR 787” on one side and blank on the other side.

Bottles of 30 NDC 49708-101-07

FIBRICOR® (fenofibric acid) Tablets 105 mg, are white, modified oval tablets, debossed “AR 788” on one side and blank on the other side.

Bottles of 30 NDC 49708-102-07
Bottles of 90 NDC 49708-102-90

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by: Mutual Pharmaceutical Company, Inc. Philadelphia, PA 19124. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202. Rev 01, October 2013

Last reviewed on RxList: 1/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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