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1、 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FIBRICORTM (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICORTM (fenofibric acid) Initial U.S. Approval: 2009 - INDICATIONS AND USAGE - FIBR
2、ICOR is a peroxisome proliferator receptor alpha (PPAR) activator indicated: To reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia ( 500 mg/dl) (1.1). To reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and t
3、o increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia (1.2). General Considerations for Treatment: The active moiety of FIBRICOR is fenofibric acid. The pharmacological effects of fenofibric acid have been extensively studied through or
4、al administration of fenofibrate, which is converted in vivo to fenofibric acid (1.3). Limitations of use: Fenofibrate as a dose equivalent to 105 mg of FIBRICOR was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 dia
5、betes mellitus (1.3). - DOSAGE AND ADMINISTRATION - FIBRICOR may be taken without regards to meals (2.1). Severe hypertriglyceridemia: 35 to 105 mg/day; the dose should be adjusted according to patient response (2.2). Primary hyperlipidemia or mixed dyslipidemia: 105 mg/day (2.2). - DOSAGE FORMS AND
6、 STRENGTHS - Tablets: 35 mg and 105 mg (3) - CONTRAINDICATIONS - Severe renal dysfunction, including patients receiving dialysis (4) Active liver disease (4) Gallbladder disease (4) Nursing Mothers (4) Known hypersensitivity to fenofibric acid or fenofibrate (4) FULL PRESCRIBING INFORMATION: CONTENT
7、S* 1 INDICATIONS AND USAGE 1.1 Severe Hypertriglyceridemia 1.2 Primary Hyperlipidemia or Mixed Dyslipidemia 1.3 Considerations of Treatment 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information 2.2 Recommended Adult Dose 2.3 Renal Impairment 2.4 Geriatric Patients 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAI
8、NDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Abnormal Liver Tests 5.2 Cholelithiasis 5.3 Concomitant Use with Oral Anticoagulants 5.4 Myopathy 5.5 Elevated Serum Creatinine 5.6 Coronary Heart Disease Morbidity and Mortality 5.7 Pancreatitis 5.8 Venothromboembolic Disease 5.9 Hypersensitivity Reactions
9、5.10 Hematological Changes 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Oral Anticoagulants 7.2 Bile-Acid Binding Resins 7.3 Immunosuppressants FIBRICOR_8_09a Rev 01, August 2009 8/14/09 - WARNINGS AND PRECAUTIONS - Fenofibrate can increase s
10、erum transaminases. Monitor liver tests periodically (5.1). Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated (5.2). Exercise caution in concomitant treatment with oral coumarin anticoagulan
11、ts. Adjust the dosage of coumarin anticoagulant to maintain the prothrombin time/INR at the desired level to prevent bleeding complications (5.3). Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risks of myopathy and rhabdomyolysis appears to be increased in elderl
12、y patients and patients with diabetes, renal failure, or hypothyroidism (5.4). Fenofibrate can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal insufficiency (5.5). - ADVERSE REACTIONS - Most common adverse reactions ( 2% and greater than placeb
13、o) are increased liver tests, abdominal pain, back pain, and headache (6). To report SUSPECTED ADVERSE REACTIONS, contact Mutual Pharmaceutical Company, Inc. at 1-888-351-3786 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch. - DRUG INTERACTIONS - Oral Anticoagulants (7.1) Bile-Acid Binding Resins
14、(7.2) Immunosuppressants (7.3) - USE IN SPECIFIC POPULATIONS - Pediatric use: The safety and effectiveness in pediatric patients have not been established (8.4). Geriatric use: Determine dose selection based on renal function (8.5). Renal impairment: Avoid in patients with severe renal impairment; dose reduction required in patients with mild to moderate renal impairment (8.6). Hepatic impairment: FIBRICOR has not been evaluated in patients with hepatic impairment (8.7). Revised: 8/2009 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers
