(fen oh fye' brate)
P : Contraindicated in pregnancy
L : Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||Hyperlipidaemias
Adult: Dose depends on the formulation used. For standard micronised formulations: Initially, 67 mg tid or 200 mg once daily, may reduce to 67 mg bid or increase to 67 mg 4 times daily. For non-micronised formulations: Initially, 200-300 mg daily in divided doses. Usual range: 200-400 mg daily. For formulations with improved bioavailability, doses between 40-160 mg daily may be used.
Child: 5 mg/kg daily.
Renal impairment: Dose reduction is necessary.
Special Populations: Reduce dose in patients with mild to moderate renal impairment: CrCl 20 mL/min: 100 mg daily; CrCl 60 mL/min: 200 mg daily.
|Administration||Should be taken with food.
|Contraindications||Hypersensitivity; severe hepatic and renal impairment. Unexplained persistent liver function abnormality and primary biliary cirrhosis; preexisting gall bladder disease. Pregnancy, lactation.|
|Special Precautions||Renal or hepatic impairment. Monitor LFTs and blood counts regularly. Increased risk of cholelithiasis, pancreatitis, skeletal muscle effects. Withdraw treatment if no adequate response after 2 mth of treatment at max recommended dose.|
|Adverse Drug Reaction(s)||Headache, dizziness, asthaenia, fatigue, arrhythmia, photosensitivity, eczema, dizziness, vaginitis, paraesthesia, rhinitis, cough, sinusitis, allergic pulmonary alveolitis, polyuria, myopathy, myositis, arthralgia, myalgia, myasthenia.
Potentially Fatal: Hepatitis, cholecystitis.
|Drug Interactions||Resins impede the absorption of fenofibrate. May increase ciclosporin concentration and associated nephrotoxicity when used together.
Potentially Fatal: Statins increase the risk of rhabdomyolysis and myopathy with renal failure. May increase the effects of oral anticoagulants. Please consult detailed drug interactions before prescribing.
|Food Interaction||Food increases the bioavailability of fenofibrate.|
|Lab Interference||Increased creatinine and gamma glutamyl transpeptidase.|
|Pregnancy Category (FDA)
||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Oral: Store at 25Â°C.|
|Pharmacology||Fenofibrate lowers plasma TG by activating lipoprotein lipase thus increasing catabolism of very low-density lipoprotein with consequent increase in high-density lipoprotein levels.
Absorption: Readily absorbed from the GI tract (oral); reduced if taken after an overnight fast.
Distribution: >99% bound to plasma albumin.
Metabolism: Rapidly via hydrolysis; converted to fenofibric acid.
Excretion: Urine (60% metabolite, glucuronide conjugate); faeces (25%); 20 hr (elimination half-life).
|ATC Classification||C10AB05 - fenofibrate; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|FENATROL||Drug International Ltd||Fenofibrate BP 200mg||Capsule||30's: 210.00 MRP|
|FENOCAP||Orion Pharma Ltd.||Fenofibrate BP 200mg||Capsule||30's: 210.90 MRP|
|FENOCOL||Peoples Pharma Ltd.||Fenofibrate BP 200mg||Capsule||30's: 184.64 MRP|
|FENOLID||General Pharmaceuticals Ltd||Fenofibrate BP 200mg||Capsule||40's: 210.90 MRP|
|FENORAT||Pacific Pharmaceuticals Ltd.||Fenofibrate BP 200mg||Capsule||30's: 210.90 MRP|
|FIBRE 200||The White Horse Pharma||Fenofibrate BP 200mg||Capsule||30's: 350.00 MRP|
|LIPIDOF||The Acme Laboratories Ltd.||Fenofibrate BP 200mg||Capsule||20's: 140.40 MRP|
|LIPIRED 160||Square Pharmaceuticals Ltd.||Fenofibrate 160mg||Tablet||3x10's: 150.60 MRP|
|LIPIRED 200||Square Pharmaceuticals Ltd.||Fenofibrate 200mg||Capsule||3x10's: 211.20 MRP|
|LOFAT||Beximco Pharmaceuticals Ltd||Fenofibrate BP 200mg||Capsule||30's: 210.00 MRP|
|Nofiate||Incepta Pharmaceuticals Limited||Fenofibrate BP (micronised) 200mg||Capsule||10x3's:MRP 210 Tk|
|NOFICON||Eskayef Bangladesh Ltd||Fenofibrate BP 200mg||Capsule||40's MRP: 280.00|
|TIGICON||Aristopharma Ltd.||Fenofibrate BP 200mg||Capsule||30's: 210.00 MRP|
|TIGIRATE||Opsonin Pharma Limited||Fenofibrate BP 200mg||Capsule||30's: 210.00 MRP|
|TRIGENT||Unimed & Unihealth Manufacturers Ltd.||Fenofibrate BP 200mg||Capsule||30's: 210.00 MRP|
Why is Fenofibrate prescribed?
Fenofibrate is used with a low-fat diet, exercise, and sometimes with other medications to reduce the amounts of fatty substances such as cholesterol and triglycerides in the blood and to increase the amount of HDL (high-density lipoprotein; a type of fatty substance that decreases the risk of heart disease) in the blood. Build-up of cholesterol and fats along the walls of the arteries (a process known as atherosclerosis) decreases the blood flow and, therefore, the oxygen supply to the heart, brain, and other parts of the body. This increases the risk of heart disease, angina (chest pain), strokes, and heart attacks. Although fenofibrate decreases the levels of fatty substances in the blood, it has not been shown to decrease the risk of heart attacks or strokes. Fenofibrate is in a class of medications called antilipemic agents. It works by speeding the natural processes that remove cholesterol from the body.
How should Fenofibrate be used?
Fenofibrate comes as a capsule, a delayed-release (long-acting) capsule, and a tablet to take by mouth. It is usually taken once a day. Some fenofibrate products should be taken with a meal while other brands may be taken with or without food. Ask your doctor if you do not know if you should take your medication with food. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take fenofibrate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of fenofibrate and may increase or decrease your dose depending on the results of laboratory tests that you will take to measure the amount of fatty substances in your blood. Your doctor may inform you to stop taking fenofibrate if your test results do not show improvement after 2 months.
Swallow the tablets whole; do not split, chew, or crush them and do not use any tablets that are chipped or broken.
Fenofibrate will help decrease the amount of fatty substances in your blood only as long as you continue to take it. Continue to take fenofibrate even if you feel well. Do not stop taking fenofibrate without talking to your doctor.
Other uses for Fenofibrate
Fenofibrate may be prescribed for other uses. Ask your doctor for more information.
What special precautions to follow?
Before taking fenofibrate,
- inform your doctor if you are allergic to any fenofibrate products, any other medications, or any of the ingredients in the fenofibrate product you are taking. Ask your pharmacist for a list of the ingredients.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants such as warfarin; colchicine; diuretics; beta blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol; HMG-CoA reductase inhibitors such as atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin; hormone replacement therapy; hormonal contraceptives; and immunosuppressants such as cyclosporine and tacrolimus . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking a bile acid resin such as cholestyramine, colesevelam, or colestipol, take it 1 hour after or 4-6 hours before you take fenofibrate.
- inform your doctor if you have or have ever had kidney, liver, or gallbladder disease. Your doctor will probably inform you not to take fenofibrate.
- inform your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had diabetes or hypothyroidism (underactive thyroid gland).
- inform your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking fenofibrate, call your doctor.
- inform your doctor if you are breast-feeding. You should not breast-feed while you are taking fenofibrate.
What special dietary instructions to follow?
Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.
What to do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Fenofibrate cause?
Fenofibrate may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
pain in the back, arm, or legs
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
muscle pain or tenderness
blistering or peeling skin
pain in the upper back between the shoulder blades or under the right shoulder
stomach pain, especially in the upper right part of the stomach
redness, swelling, pain, tenderness, or warmth in one leg
shortness of breath
pain when breathing
coughing up blood
Fenofibrate may cause other side effects. Call your doctor if you have any unusual problems while you are taking fenofibrate.
What to know about storage and disposal of Fenofibrate?
Keep Fenofibrate in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Fenofibrate.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.