Halton Laboratories

Halton Laboratories Drugs

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  2.1 General Considerations

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

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid tablets 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 fenofibric acid tablets. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 105 mg per day.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 fenofibric acid tablets if lipid levels fall significantly below the targeted range.

  2.2 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.

  2.3 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The dose of fenofibric acid tablets is 105 mg per day.

  2.4 Impaired Renal Function

  In patients with mild-to-moderate renal impairment, treatment with fenofibric acid tablets 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 fenofibric acid tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose 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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