"The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemi"...
Fenofibrate 40 mg/ 120 mg
Primary Hypercholesterolemia Or Mixed Dys lipidemia
Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Fenofibrate capsules are 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 150 mg was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
Sections or subsections omitted from the full prescribing information are not listed.
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.
Primary Hypercholesterolemia Or Mixed Dys lipidemia
The dose of fenofibrate capsules is 150 mg once daily.
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.
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 and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
- 50 mg: Size 3 white opaque gelatin capsule imprinted “G 246” and “50” in black ink.
- 150 mg: Size 1 white opaque gelatin capsule imprinted “G 248” and “150” in green ink.
Storage And Handling
Fenofibrate Capsules USP are available in two strengths:
50 mg: Size 3 white opaque/white opaque gelatin capsule, imprinted in black ink with “50” between lines on the body, “G 246” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 62559-460-90).
150 mg: Size 1 white opaque/white opaque gelatin capsule, imprinted in green ink with “150” between lines on the body, “G 248” on the cap and containing a white to almost white paste, available in bottles of 90 (NDC 62559-461-90).
Store at 25°C; excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture and light.
Manufactured for: ANI Pharmaceuticals, Inc., Baudette, MN 56623. Revised: Feb 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/6/2016
Additional Fenofibrate 40 mg/ 120 mg Information
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