fenofibric acid 45 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Fenofibric acid delayed release capsules are a peroxisome proliferator receptor alpha (PPARα) activator indicated: •In combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal ( 1.1 ). •As monotherapy to reduce TG in patients with severe hypertriglyceridemia ( 1.2 ). •As monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.3 ). Important Limitations of Use: No incremental benefit of fenofibric acid delayed release capsules on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed release capsules was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. 1.1 Coadministration Therapy with Statins for the Treatment of Mixed Dyslipidemia Fenofibric acid delayed-release capsules are indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal. CHD risk equivalents comprise: •Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm and symptomatic carotid artery disease); •Diabetes; •Multiple risk factors that confer a 10 year risk for CHD > 20% 1.2 Treatment of Severe Hypertriglyceridemia Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. 1.3 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia Fenofibric acid delayed-release capsules are 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. 1.4 Important Limitations of Use No incremental benefit of fenofibric acid delayed-release capsules on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus. 1.5 General Considerations for Treatment Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy. Every reasonable attempt should be made to control serum lipids with nondrug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet. Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
Mylan Institutional Inc.
CAPSULE BROWN Mylan CF 45
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16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibric Acid Delayed-release capsules contains choline fenofibrate equivalent to 45 mg or 135 mg of fenofibric acid. The 45 mg capsules are hard-shell gelatin capsules with a brown-pink opaque cap and light yellow opaque body, fill with white to off-white enteric coated pellets. The capsule is axially printed with MYLAN over CF 45 in black ink on the cap and body. They are available as follows: NDC 51079-195-03 - Unit dose blister packages of 30 (3 cards of 10 capsules each). The 135 mg capsules are hard-shell gelatin capsules with a powder blue opaque cap and light yellow opaque body filled with white to off-white enteric coated pellets. The capsule is axially printed with MYLAN over CF 135 in black ink on the cap and body. They are available as follows: NDC 51079-196-03 - Unit dose blister packages of 30 (3 cards of 10 capsules each). Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. PHARMACIST: Dispense a Medication Guide with each prescription.
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