DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Lofibra (Fenofibrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Primary Hypercholesterolemia or Mixed Dyslipidemia

LOFIBRA is 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.

Severe Hypertriglyceridemia

LOFIBRA 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.

Important Limitations of Use

Fenofibrate at a dose equivalent to 145 mg of LOFIBRA 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

General Considerations

Patients should be placed on an appropriate lipid-lowering diet before receiving LOFIBRA, and should continue this diet during treatment with LOFIBRA. LOFIBRA tablets can be given without regard to meals.

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 LOFIBRA 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.

Primary Hypercholesterolemia or Mixed Dyslipidemia

The initial dose of LOFIBRA is 160 mg once daily.

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.

Impaired Renal Function

Treatment with LOFIBRA 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 LOFIBRA should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].

Geriatric Patients

Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.5)].

DOSAGE FORMS AND STRENGTHS

  • 54 mg: Yellow, round-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7330” on the other side.
  • 160 mg: White to off white, oval-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7331” on the other side.

HOW SUPPLIED/STORAGE AND HANDLING

LOFIBRA (fenofibrate tablets) are supplied as follows:

54 mg - Yellow, round-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7330” on the other side. Available in bottles of 90.

160 mg - White to off white, oval-shaped, film-coated, unscored tablet, debossed with “93” on one side and “7331” on the other side. Available in bottles of 90.

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017