Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)
REMEDYREPACK INC.
CLOPIDOGREL BISULFATE
CLOPIDOGREL 75 mg
ORAL
PRESCRIPTION DRUG
- Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin. - Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin. In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel bisulfate 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 tab
Clopidogrel tablets, USP 75-mg are available as light pink colored, round, beveled edge, biconvex film coated tablets printed "41" with black ink on one side and plain on the other side. Tablets are provide as follow: Bottles of 30 NDC 13668-141-30 Bottles of 90 NDC 13668-141-90 Bottles of 100 NDC 13668-141-01 Bottles of 500 NDC 13668-141-05 Bottles of 1000 NDC 13668-141-10 Bottles of 3100 NDC 13668-141-44 100 (10 X 10) Unit Dose Tablets NDC 13668-141-74 Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- SPL MEDGUIDE Medication Guide Clopidogrel (kloe PID oh grel) Tablets, USP 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: • have certain genetic factors that affect how the body breaks down clopidogrel tablets. Your doctor may do genetic tests to make sure clopidogrel tablets are right for you. • 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 tablets are blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopidogrel tablets: • you may bruise and bleed more easily • you are more likely to have nose bleeds • 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 tablets? Clopidogrel tablets are prescription medicine used to treat people who have any of the Read the complete document
CLOPIDOGREL BISULFATE- CLOPIDOGREL BISULFATE TABLET REMEDYREPACK INC. ---------- 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._ EFFECTIVENESS OF CLOPIDOGREL BISULFATEDEPENDS 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 P2Y12 INHIBITOR IN PATIENTS IDENTIFIED AS CYP2C19 POOR METABOLIZERS. (5.1) INDICATIONS AND USAGE Clopidogrel tablets are P2Y platelet inhibitor indicated for: (1) ● Acute coronary syndrome (1) – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) (1) – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1) (1) ● Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2) (1) DOSAGE AND ADMINISTRATION ● Acute coronary syndrome (2.1) (2) – Initiate clopidogrel tablets with a single 300-mg oral loading dose and then continue at 75 mg once daily. (2) – Initiating clopidogrel tablets without a loading dose will delay establishment of an antiplatelet effect by several days. (2) ● Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily orally without a loading dose (2.2) (2) DOSAGE FORMS AND STRENGTHS Tablets: 75 mg (3) (3) CONTRAINDICATIONS Active pathologic Read the complete document