Colestrim Tablets

Fenofibrate tablet USP is a peroxisome proliferator-activated receptor (PPAR) alpha agonist 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 ). Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1 ). …

• Primary hypercholesterolemia or mixed dyslipidemia: Initial dose of 160 mg once daily
• Severe hypertriglyceridemia: Initial dose of 54 to 160 mg once daily
• Maximum dose is 160 mg
• Renally impaired patients: Initial dose of 54 mg once daily
• Geriatric patients: Select the dose on the basis of renal function
• Should be given with meals
• General Considerations Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate tablet USP, and should continue this diet during treatment with fenofibrate tablet USP
• Fenofibrate tablets USP should be given with meals, thereby optimizing the bioavailability of the medication
• 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. …

Oral Tablets: 54 mg and 160 mg ( 3 ). 54 mg white to off white, round, biconvex tablets debossed with "LU" on one side and "J41" on the other side. 160 mg white to off white, oval shaped tablets debossed with "LU" on one side and "J42" on the other side.

• Safety and effectiveness have not been established
• In pediatric patients

Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Fenofibric acid exposure is not influenced by age. Since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see DOSAGE AND ADMINISTRATION ( 2.5 ) and CLINICAL PHARMACOLOGY ( 12.3 )] . …

Patients should be advised: of the potential benefits and risks of fenofibrate tablet. not to use fenofibrate tablet if there is a known hypersensitivity to fenofibrate or fenofibric acid. of medications that should not be taken in combination with fenofibrate tablet. that if they are taking coumarin anticoagulants, fenofibrate tablet may increase their anti-coagulant effect, and increased monitoring may be necessary. to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablet. to take fenofibrate tablet once daily with a meal at the prescribed dose, swallowing each tablet whole. to return to their physician's office for routine monitoring. …

• Severe renal dysfunction, including dialysis patients
• Active liver disease
• Gallbladder disease
• Known hypersensitivity to fenofibrate
• Nursing mothers
• Fenofibrate is contraindicated in: patients with severe renal impairment, including those receiving dialysis [see CLINICAL PHARMACOLOGY ] . …

Coumarin anticoagulants: ( 7.1 ). Immunosuppressants: ( 7.2 ). Bile acid resins: ( 7.3 ). 7.1 Coumarin Anticoagulants Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibrate. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized [see WARNINGS AND PRECAUTIONS (5.6)] . …

Hepatotoxicity : Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrate. Monitor patient's liver function, including serum ALT, AST, and total bilirubin, atbaseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist ( 5.2 ). Myopathy and rhabdomyolysis: Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin (with a significantly higher rate observed for gemfibrozil), particularly in elderly patients and patients with diabetes, renal failure, or hypothyroidism ( 5.3 ). …

The following serious adverse reactions are described below and elsewhere in the labeling: •Mortality and coronary heart disease morbidity [see WARNINGS AND PRECAUTIONS ( 5.1 )] •Hepatoxicity [see WARNINGS AND PRECAUTIONS ( 5.2 )] •Pancreatitis [see WARNINGS AND PRECAUTIONS ( 5.7 )] •Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS ( 5.9 )] • Venothromboembolic disease [see WARNINGS AND PRECAUTIONS ( 5.10 )] Adverse reactions > 2% and at least 1% greater than placebo: Abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. …

8.1 Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or equivalent to the maximum recommended clinical d …

There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.