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非诺贝酸片|FIBRICOR(FENOFIBRIC ACID)

2011-01-08 18:00:25  作者:新特药房  来源:中国新特药网天津分站  浏览次数:726  文字大小:【】【】【
简介: 中文名:非诺贝酸片 英文名:Fenofibric Acid 别名:2-[4-(4-Chlorobenzoyl)Phenoxy]-2-Methyl-Propanoic Acid非诺贝酸; 2-[4-(4-氯苯甲酰基)苯氧基]-2-甲基丙酸 所属类别:降血脂药 FENOFIBRI ...

中文名:非诺贝酸片

英文名:Fenofibric Acid

别名:2-[4-(4-Chlorobenzoyl)Phenoxy]-2-Methyl-Propanoic Acid
非诺贝酸; 2-[4-(4-氯苯甲酰基)苯氧基]-2-甲基丙酸

所属类别:降血脂药

FENOFIBRIC ACID - ORAL
Pronunciation:
(FEN-oh-FYE-brick AS-id)
Brand Name(s): Fibricor

Fibricor Oral Uses
Fenofibric acid is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "fibrates." It works by increasing the natural substance (enzyme) that breaks down fats in the blood. In general, this drug is prescribed after non-drug treatments (such as diet change, decreased alcohol use, increased exercise, weight loss if overweight) have not been fully successful at lowering cholesterol. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol may help decrease the risk for strokes and heart attacks.

How to use Fibricor Oral
Take this medication by mouth with or without food, usually once daily or as directed by your doctor.

Dosage is based on your medical condition and response to treatment. Do not take more than 105 milligrams per day.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fenofibric acid at least 1 hour before or at least 4-6 hours after taking these medications. These products can react with fenofibric acid, preventing its full absorption.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol/triglycerides do not feel sick.

It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 2 months before you get the full benefit of this drug.

Fibricor Oral Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause gallstones and liver problems. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), chest pain, pain/redness/swelling of arms or legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Fibricor Oral Precautions
Before taking fenofibric acid, tell your doctor or pharmacist if you are allergic to it; or to other "fibrates" (such as fenofibrate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as biliary cirrhosis, hepatitis), gallbladder disease.

Older adults may be more sensitive to the effects of this drug, especially muscle problems.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Fibricor Oral Interactions
See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), drugs that may be harmful to the kidneys (such as cyclosporine, tacrolimus).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Fibricor Oral Overdose
If overdose is suspected, contact a local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:
Do not share this medication with others.

Laboratory and/or medical tests (such as cholesterol/triglyceride levels, kidney/liver function tests, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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FIBRICOR

Indication(s):

 

Adjunct to diet in severe hypertriglyceridemia (≥500mg/dL), and to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein (Apo) B, and triglyceride (TG), and to increase high-density lipoprotein cholesterol (HDL-C), in primary hypercholesterolemia and mixed dyslipidemia.

Pharmacology:

Elevated levels of total-C, LDL-C, Apo B, and decreased levels of HDL-C and its transport complex, Apo A-I and Apo A-II, have been shown to increase the risk for atherosclerosis. Fenofibric acid, the active moiety of fenofibrate, is a lipid modifying agent that increases lipolysis and the elimination of TG-rich particles from plasma by activating lipoprotein lipase and reducing the production of apolipoprotein CIII.

Clinical Trials:

Two randomized, double-blind, placebo-controlled clinical trials were conducted in 147 patients with hypertriglyceridemia to evaluate the effects of fenofibrate on serum triglycerides. Patients were treated for eight weeks with fenofibrate or placebo under protocols that differed only in that one protocol entered patients with baseline TG levels of 500–1500mg/dL, and the other TG levels of 350–500mg/dL. In Studies 1 and 2, in patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia, treatment with fenofibrate at dosages equivalent to 105mg of Fibricor reduced TG by 46.2% and 54.5%, respectively; very low density lipoprotein (VLDL) TG by 44.1% and 50.6%, respectively; and VLDL-C by 44.7% and 49.4%, respectively (all p<0.05 versus placebo).

Four randomized, placebo-controlled, double-blind, parallel-group clinical trials were conducted to evaluate the effects of fenofibrate at doses equivalent to Fibricor 105mg in patients with primary hyperlipidemia and mixed dyslipidemia. Patients were treated for a duration of 3–6 months. In the pooled cohort, fenofibrate therapy lowered total-C by 18.7%, LDL-C by 20.6%, TG by 28.9%, and raised HDL-C by 11% (all p<0.05 versus placebo). In a subset of patients, measurement of Apo B was evaluated. Fenofibrate significantly reduced Apo B from baseline to endpoint as compared to placebo (25.1% versus 2.4%; p<0.0001).

Legal Classification:

Rx

Adults:

Hypertriglyceridemia: 35–105mg/day, adjust at 4–8 week intervals. Hypercholesterolemia, dyslipidemia: 105mg/day. Renal impairment: initially 35mg/day. Discontinue if inadequate response after 2 months on max dose.

Children:

Not recommended.

Contraindication(s):

Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.

Warnings/Precautions:

Renal impairment. Monitor CBCs for first year; monitor liver function; discontinue if ALT levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones occur. Elderly. Pregnancy (Cat.C).

Interaction(s):

May potentiate oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.

Adverse Reaction(s):

Increased liver tests, abdominal pain, back pain, headache; elevated CPK, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, transient hematologic changes, blood dyscrasias, thromboembolic disorders, rhabdomyolysis.

How Supplied:

Tabs—30, 60, 90, 100, 250, 500, 1000

Last Updated:

10/8/2009

责任编辑:admin


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