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H2-pharma, Llc Drugs
2.1 General Considerations
Fenofibrate capsules should be given with meals thereby optimizing the absorption of the medication.
Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.
Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate capsules.
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 fenofibrate. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 150 mg per day.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 fenofibrate if lipid levels fall significantly below the targeted range.
2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia
The dose of fenofibrate capsules 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 fenofibrate capsules is 150 mg once daily.
2.4 Impaired Renal Function
In patients with mild-to-moderate renal impairment, treatment with fenofibrate capsules 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 fenofibrate 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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