Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
Major Pharmaceuticals
CLOPIDOGREL BISULFATE
CLOPIDOGREL 300 mg
ORAL
PRESCRIPTION DRUG
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke. Clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)] . Risk Summary Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data] . There are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see Clinical Considerations] . No evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses correspondi
Clopidogrel tablets, USP 300 mg are pink, oblong, biconvex, film-coated tablets, engraved "APO" on one side and "CL 300" on the other side. They are supplied as follows: Carton of 20 tablets (10 tablets per blister pack x 2), NDC 0904-6467-10 Carton of 30 tablets (10 tablets per blister pack x 3), NDC 0904-6467-07 Store at 25°C(77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED Major Pharmaceuticals ---------- MEDICATION GUIDE Clopidogrel Tablets, USP 75 mg and 300 mg (kloe pid’ oh grel) Medication Guide available at www1.apotex.com/products/us Read this Medication Guide before you start taking clopidogrel tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about clopidogrel tablets? 1. Clopidogrel tablets may not work as well in people who: 1. have certain genetic factors that affect how the body breaks down clopidogrel. Your doctor may do genetic tests to make sure clopidogrel is right for you. 2. take certain medicines, especially omeprazole (Prilosec®) or esomeprazole (Nexium®). Your doctor may change the medicine you take for stomach acid problems while you take clopidogrel tablets. 2. Clopidogrel tablets can cause bleeding which can be serious and can sometimes lead to death. Clopidogrel is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopidogrel tablets: 1. you may bruise and bleed more easily 2. you are more likely to have nose bleeds 3. it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: • unexpected bleeding or bleeding that lasts a long time • blood in your urine (pink, red or brown urine) • red or black stools (looks like tar) • bruises that happen without a known cause or get larger • cough up blood or blood clots • vomit blood or your vomit looks like coffee grounds Do not stop taking clopidogrel tablets without talking to the doctor who prescribes it for you. People who stop taking clopidogrel tablets too soon have a higher risk of having a heart attack or dying. If you must stop clopidogrel tablets because of bleeding, your risk of a heart attack may be higher. What are clopidogrel Read the complete document
CLOPIDOGREL- CLOPIDOGREL BISULFATE TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOPIDOGREL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOPIDOGREL TABLETS. CLOPIDOGREL TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF- FUNCTION ALLELES OF THE CYP2C19 GENE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • INDICATIONS AND USAGE Clopidogrel tablets are a P2Y platelet inhibitor indicated for: 2. - For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) 2. DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Film-coated tablets: 75 mg, 300 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • EFFECTIVENESS OF CLOPIDOGREL TABLETS DEPENDS ON CONVERSION TO AN ACTIVE METABOLITE BY THE CYTOCHROME P450 (CYP) SYSTEM, PRINCIPALLY CYP2C19. (5.1, 12.3) TESTS ARE AVAILABLE TO IDENTIFY PATIENTS WHO ARE CYP2C19 POOR METABOLIZERS. (12.5) CONSIDER USE OF ANOTHER PLATELET P2Y INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (5.1) 12 12 Acute coronary syndrome Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2) Acute coronary syndrome (2.1) 3. 4. Initiate clopidogrel with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiating clopidogrel without a loading dose will delay establishment of an antiplatelet effect by several days. Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose. Read the complete document