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P : Contraindicated in pregnancy
L : Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
Adult: PO 1.2 g/day in 2 divided doses. Maintenance: 0.9-1.5 g/day.
|Administration||May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
|Contraindications||Hypersensitivity. Severe hepatic or renal dysfunction; gall stones; neonates, children, pregnancy, lactation.|
|Special Precautions||Causes of secondary hyperlipidaemia such as hypothyroidism and diabetes must be treated before initiating therapy. Renal impairment; blood disorders. Periodic monitoring of the serum lipids should be done; if no adequate response after 3 mth, treatment should be withdrawn. May increase risk of cholelithiasis.|
|Adverse Drug Reaction(s)||Myositic syndrome, cholelithiasis, GI disturbances, rash, headache, blood dyscrasias, myalgia. Impotence, painful extremities, blurred vision; pruritus, urticaria; impotence; dizziness; cholestatic jaundice.
Potentially Fatal: Bone marrow hypoplasia; intracranial haemorrhage; nephrotoxicity; peripheral neuritis.
|Drug Interactions||Co-admin with repaglinide may increase serum levels of repaglinide. May enhance effects of oral anticoagulants. May also increase the plasma concentrations of ciclosporin and associated nephrotoxicity when used concurrently.
Potentially Fatal: Increased risk of myopathy and rhabdomyolysis when used with HMG-CoA reductase inhibitors. Please consult detailed drug interactions before prescribing.
|Lab Interference||May cause elevations of AST, ALT, bilirubin, and alkaline phosphatase.|
|Storage||Store below 30Â°C.|
|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.|
|Pharmacology||Gemfibrozil exhibits its action by inhibition of lipolysis and reduction of hepatic fatty acid uptake. It also inhibits secretion of VLDL from the liver.
Absorption: Readily absorbed from the GI tract (oral); peak plasma concentrations after 1-2 hr.
Distribution: Protein-binding: 80%.
Metabolism: Hepatic via oxidation; undergoes enterohepatic recirculation.
Excretion: Urine (70% glucuronide conjugates and metabolites); faeces (small amounts); 1.5 hr (elimination half-life).
|ATC Classification||C10AB04 - gemfibrozil; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|DELIPID CAP||Square Pharmaceuticals Ltd.||Gemfibrozil 300mg||Capsule||5x6's: 210.90 MRP|
|FIBRIL||Beximco Pharmaceuticals Ltd||Gemfibrozil USP 300mg||Capsule||30's: 210.00 MRP|
|GELICON||Eskayef Bangladesh Ltd||Gemfibrozil USP 300mg||Capsule||24's MRP: 168.00|
Why is Gemfibrozil prescribed?
Gemfibrozil is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and triglycerides (other fatty substances) in the blood in certain people with very high triglycerides who are at risk of pancreatic disease (conditions affecting the pancreas, a gland that produces fluid to break down food and hormones to control blood sugar). Gemfibrozil is also used in people with a combination of low high-density lipoprotein (HDL; 'good cholesterol') levels and high low-density lipoprotein (LDL; 'bad cholesterol') and triglyceride levels. Gemfibrozil is in a class of lipid-regulating medications called fibrates. It works by reducing the production of triglycerides in the liver.
Buildup of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help to decrease your chances of getting heart disease, angina (chest pain), strokes, and heart attacks. In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your cholesterol blood levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY), exercise 30 minutes on most, if not all days, and lose weight if you are overweight.
How should Gemfibrozil be used?
Gemfibrozil may come as a tablet to take by mouth. It is usually taken twice a day, 30 minutes before the morning and evening meals. Take gemfibrozil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take gemfibrozil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Gemfibrozil controls high cholesterol and triglycerides but does not cure them. Continue to take gemfibrozil even if you feel well. Do not stop taking gemfibrozil without talking to your doctor.
Other uses for Gemfibrozil
Gemfibrozil may be prescribed for other uses; ask your doctor for more information.
What special precautions to follow?
Before taking gemfibrozil,
- inform your doctor if you are allergic to gemfibrozil or any other medications.
- inform your doctor if you are taking cerivastatin. Your doctor will inform you not to take gemfibrozil while taking cerivastatin.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin; cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin, pravastatin, and simvastatin; and repaglinide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- inform your doctor if you have kidney, liver, or gallbladder disease. Your doctor may inform you not to take gemfibrozil.
- inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking gemfibrozil, call your doctor.
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 Gemfibrozil cause?
Gemfibrozil may cause side effects. inform your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
muscle pain, tenderness, or weakness
A medication similar to gemfibrozil has caused cancer, gallbladder disease, and stomach pain leading to appendectomy. Talk to your doctor about the risks of taking Gemfibrozil.
Gemfibrozil may cause other side effects. Call your doctor if you have any unusual problems while taking Gemfibrozil.
What to know about storage and disposal of Gemfibrozil?
Keep Gemfibrozil 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.
Symptoms of overdose may include:
joint and muscle pain
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 Gemfibrozil.
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.