国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)
LUPIN LIMITED
FENOFIBRATE
FENOFIBRATE 48 mg
ORAL
PRESCRIPTION DRUG
Fenofibrate tablets USP are 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. Fenofibrate tablets USP are 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. Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patient
Fenofibrate tablets USP are available in two strengths: 48 mg, yellow colored, oval shaped, film-coated tablets, debossed with "LU" on one side and "B21" on the other side. They are supplied as follows: NDC 68180-360-09 Bottles of 90's NDC 68180-360-02 Bottles of 500's 145 mg, white to off-white colored, oval shaped, film-coated tablets, debossed with "LU" on one side and "B22" on the other side. They are supplied as follows: NDC 68180-361-09 Bottles of 90's NDC 68180-361-02 Bottles of 500's NDC 68180-361-03 Bottles of 1000's Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
Abbreviated New Drug Application
FENOFIBRATE- FENOFIBRATE TABLET LUPIN LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FENOFIBRATE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENOFIBRATE TABLETS USP. FENOFIBRATE TABLETS USP FOR ORAL USE INITIAL U.S. APPROVAL: 1993 INDICATIONS AND USAGE Fenofibrate is a peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1). For treatment of adult patients with severe hypertriglyceridemia (1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1). DOSAGE AND ADMINISTRATION Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 145 mg once daily (2.2). Severe hypertriglyceridemia: Initial dose of 48 to 145 mg once daily. Maximum dose is 145 mg (2.3). Renally impaired patients: Initial dose of 48 mg once daily (2.4). Geriatric patients: Select the dose on the basis of renal function (2.5) May be taken without regard to meals (2.1). DOSAGE FORMS AND STRENGTHS Oral Tablets: 48 mg and 145 mg (3). CONTRAINDICATIONS Severe renal dysfunction, including patients receiving dialysis (4, 8.6, 12.3). Active liver disease (4, 5.3). Gallbladder disease (4, 5.5). Known hypersensitivity to fenofibrate (4). Nursing mothers (4, 8.3). WARNINGS AND PRECAUTIONS Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism (5.2). Fenofibrate can increase serum transaminases. Monitor liver tests, including ALT, periodically during therapy (5.3). Fenofibrate can 阅读完整的文件