(kloh pid' oh grel)
P / L : Caution during pregnancy and contraindicated during lactation
|| See TERMINOLOGY & ABBREVIATIONS |
DIMINISHED EFFECTIVENESS IN POOR METABOLIZERSThe effectiveness of Plavix is dependent on its activation to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Plavix at recommended doses forms less of that metabolite and has a smaller effect on platelet function in patients who are CYP2C19 poor metabolizers. Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with Plavix at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function. Tests are available to identify a patient's CYP2C19 genotype; these tests can be used as an aid in determining therapeutic. Consider alternative treatment or treatment strategies in patients identified as CYP2C19 poor metabolizers.
|Indication(s) & Dosage||Prophylaxis of thromboembolic disorders
Adult: 75 mg once daily orally.
Acute coronary syndrome
Adult: For ST-elevation myocardial infarction: In combination with aspirin: 75 mg once daily. Patients ≥75 yr old may be given a loading dose of 300 mg. Continue treatment for up to 28 days. For unstable angina, non-ST-elevation myocardial infarction: Initial: 300 mg loading dose, followed by 75 mg once daily (with aspirin 75-325 mg once daily).
|Administration||May be taken with or without food.
|Overdosage||Prolonged bleeding time and subsequent bleeding complications. If quick reversal is required, platelet transfusion may be considered.|
|Contraindications||Hypersensitivity. Active pathological bleeding. admin within 7 days after MI and ischaemic stroke, coagulation disorders. Lactation.|
|Special Precautions||Patients at risk of increased bleeding from trauma, surgery, or other pathological conditions; ulcer; renal and hepatic impairment; history of bleeding or haemostatic disorders. Pregnancy.|
|Adverse Drug Reactions
||Dyspepsia, abdominal pain, nausea, vomiting, flatulence, constipation, gastritis, gastric and duodenal ulcers. GI upset, diarrhoea, paraesthesia, vertigo, headache, dizziness, pruritus and rashes.
Potentially Fatal: Bleeding disorders including GI and intracranial haemorrhage. Blood dyscrasias.
|Drug Interactions||Co-admin with NSAIDs may increase the risk of stomach and intestinal bleeding. High-dose clopidogrel may lead to increased warfarin levels thus increasing the risk of bleeding. High-dose clopidogrel may also inhibit P450 (2C9), thus interfering with the metabolism of phenytoin, tamoxifen, torasemide, fluvastatin and some NSAIDs. Avoid concurrent use of drugs that inhibit CYP2C19, including omeprazole, esomeprazole, cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine and ticlopidine. Please consult detailed drug interactions before prescribing.|
|Pregnancy Category (FDA)||Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).|
|Storage||Oral: Store at 25°C.|
|Pharmacology||Clopidogrel inhibits adenosine diphosphate (ADP) from binding to its receptor sites on the platelets and subsequent activation of glycoprotein GP IIb/IIIa complex thus preventing fibrinogen binding, platelet adhesion and aggregation.
Absorption: Rapidly but incompletely absorbed from the GI tract (oral).
Distribution: Protein-binding: Extensive.
Metabolism: Hepatic: Extensive; converted to inactive carboxylic acid derivative and thiol derivative (active).
Excretion: Via urine and faeces (as metabolites and unchanged drug).
|ATC Classification||B01AC04 - clopidogrel; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|ANCLOG 75||Square Pharmaceuticals Ltd.||Clopidogrel 75mg||Tablet||4x10's: 481.20 MRP|
|ANLET-75||Globe Pharmaceuticals Ltd||Clopidogrel bisulphate INN 75mg||Tablet||30's: 240.00 MRP|
|ANPLAT||R A K Pharmaceuticals Pvt. Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 300.00 MRP|
|ANTIPLET||Rangs Pharmaceuticals Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 300.00 MRP|
|CARDOGREL||Pharmasia Limited||Clopidogrel bisulphate INN 75mg||Tablet||20's: 200.80 MRP|
|CLAVIX||Techno Drugs||Clopidogrel bisulphate INN 75mg||Tablet||30's: 420.00 MRP|
|CLOGNIL||Orion Pharma Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 301.20 MRP|
|CLONT||Opsonin Pharma Limited||Clopidogrel bisulphate INN 75mg||Tablet||30's: 300.00 MRP|
|CLOPID||Drug International Ltd||Clopidogrel bisulphate INN 75mg||Tablet||50's: 600.00 MRP|
|CLOPIGEL||Pacific Pharmaceuticals Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 273.00 MRP|
|CLOPILET||Sun Pharmaceutical (Bangladesh) Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||50's: 552.50 MRP|
|CLOPIREL||Novo Healthcare and Pharma Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 300.00 MRP|
|CLOREL||ACI Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 301.20 MRP|
|CLOTINIL||Rephco Laboratories Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 330.00 MRP|
|DCLOT||The Acme Laboratories Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 301.20 MRP|
|FREE||Nipa Pharmaceuticals Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||20's: 200.75 MRP|
|LIVOCARD||The White Horse Pharma||Clopidogrel bisulphate INN 75mg||Tablet||30's: 270.00 MRP|
|Lopirel||Incepta Pharmaceuticals Limited||Clopidogrel bisulphate INN equivalent to Clopidogrel 75 mg||Film Coated Tablet||10x3's:MRP 360 Tk|
|NOCLOG||Eskayef Bangladesh Ltd||Clopidogrel bisulphate INN equivalent to Clopidogrel 75mg||Tablet||20's MRP: 200.00|
|ODREL||Beximco Pharmaceuticals Ltd||Clopidogrel Bisulphate INN equivalent to Clopidogrel 75mg||Tablet||10 & 30's: 120 & 360.00 MRP|
|PLADEX||Unimed & Unihealth Manufacturers Ltd.||Clopidogrel bisulphate INN 75mg||Tablet||30's: 360.00 MRP|
|PLAGRIN||Renata Limited||Clopidogrel bisulphate INN 75mg||Film Coated Tablet||20's: 200.80 MRP|
|PLATREL||Sandoz/Novartis||Clopidogrel bisulphate INN equivalent to Clopidogrel 75mg||Film Coated Tablet||3x10's, MRP 375.00|
|PLAVIX||Navana Pharmaceuticals Limited||Clopidogrel bisulphate INN 75mg||Film Coated Tablet||20's: 200.80 IP|
|PRECLOT||Popular Pharmaceuticals Ltd.||Clopidogrel bisulphate INN 75mg||Film Coated Tablet||20's: 200.80 MRP|
|REPLET||Healthcare Pharmacuticals Ltd.||Clopidogrel Bisulphate INN equivalent to Clopidogrel 75mg||Tablet||30's MRP 300 Tk|
Clopidogrel must be changed to an active form in your body so that it can treat your condition. Some people do not change clopidogrel to its active form in the body as well as other people. Because the medication does not work as well in these people, they may be at a higher risk of having a heart attack or stroke. There are tests available to identify people who have trouble changing clopidogrel to an active form. Talk to your doctor about whether you should be tested. If you are found to have difficulty converting clopidogrel to its active form, your doctor may change your dose of clopidogrel or tell you not to take clopidogrel.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clopidogrel and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking clopidogrel.
Why is this medication prescribed?
Clopidogrel is used alone or with aspirin to prevent serious or life-threatening problems with the heart and blood vessels in people who have had a stroke, heart attack, or severe chest pain. This includes people who have percutaneous coronary intervention (PCI; angioplasty; a type of heart surgery) that may involve inserting coronary stents (metal tubes surgically placed in clogged blood vessels to improve blood flow) or who have coronary artery bypass grafting (CABG; a type of heart surgery). Clopidogrel is also used to prevent serious or life-threatening problems with the heart and blood vessels in people who have peripheral arterial disease (poor circulation in the blood vessels that supply blood to the legs). Clopidogrel is in a class of medications called antiplatelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
How should this medicine be used?
Clopidogrel comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take clopidogrel at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take clopidogrel exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Clopidogrel will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Continue to take clopidogrel even if you feel well. Do not stop taking clopidogrel without talking to your doctor. If you stop taking clopidogrel, there is a higher risk that you may have a heart attack or stroke. If you have a stent, there is also a higher risk that you could develop a blood clot in the stent if you stop taking clopidogrel too soon.
Other uses for this medicine
Clopidogrel is also sometimes used to prevent blood clots in people with atrial fibrillation (a condition in which the heart beats irregularly). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking clopidogrel,
- tell your doctor if you are allergic to clopidogrel, any other medications, or any ingredient in clopidogrel tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor what other 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; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and naproxen; cilostazol; etravirine; fluoxetine; fluvoxamine; ketoconazole (Nizoral); lansoprazole; and ticlopidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you are taking omeprazole or esomeprazole for stomach acid problems. Your doctor may tell you to take a different medication for stomach acid problems while you are taking clopidogrel.
- tell your doctor if you have bleeding ulcers (sores in the lining of the stomach or small intestine that are bleeding), bleeding in the brain, or any other condition that causes severe bleeding. Your doctor may tell you that you should not take clopidogrel.
- tell your doctor if you have recently been injured and if you have or have ever had liver or kidney disease or any condition that may cause bleeding, including stomach problems such as ulcers and certain eye problems.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking clopidogrel, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clopidogrel.
- you should know that you may bleed more easily or for a longer time than usual while you are taking clopidogrel. Be careful not to cut or hurt yourself while you are taking clopidogrel.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I 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 this medication cause?
Clopidogrel may cause side effects. Tell 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 the following symptoms, call your doctor immediately:
difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
black and tarry stools
red blood in stools
vomit that looks like coffee grounds
unusual bleeding or bruising
slow or difficult speech
weakness or numbness of an arm or a leg
changes in vision
shortness of breath
purple patches or bleeding under the skin
yellowing of the skin or eyes
Clopidogrel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
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.
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*Trademark name & prescribing information are the property of their respective Manufacturers.