Eden Clopidogrel Tablets

Clopidogrel is a P2Y 12 platelet inhibitor indicated for: • Acute coronary syndrome -For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) • Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. …

• Acute coronary syndrome - 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
• Acute Coronary Syndrome In patients who need an antiplatelet effect within hours, 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 [ see Clinical Pharmacology and Clinical Studies ]
• Recent MI, Recent Stroke, or Established Peripheral Arterial Disease 75 mg once daily orally without a loading dose [ see Clinical Pharmacology and Clinical Studies ]

Clopidogrel tablets USP, 75 mg tablets: Pink colored, circular, biconvex, film-coated tablets debossed with “L 11” on one side and plain on other side Film-coated tablets: 75 mg. ( 3 )

• Safety and effectiveness
• In pediatric populations have not been established
• A randomized, placebo-controlled trial (CLARINET) did not demonstrate a clinical benefit of clopidogrel in
• Neonates and
• Infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt
• Possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin, and the late initiation of therapy following shunt palliation. …

Of the total number of subjects in the CAPRIE and CURE controlled clinical studies, approximately 50% of patients treated with clopidogrel were 65 years of age and older, and 15% were 75 years and older. In COMMIT, approximately 58% of the patients treated with clopidogrel were 60 years and older, 26% of whom were 70 years and older. …

• Advise patients to read FDA approved patient labeling (Medication Guide)
• Discontinuation Advise patients not to discontinue clopidogrel without first discussing it with the healthcare provider who prescribed it [see Warnings and Precautions ]
• Bleeding Advise patients that they: • will bruise and bleed more easily • will take longer than usual to stop bleeding • must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions ] Thrombotic Thrombocytopenic Purpura Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [ see Warnings and Precautions ( 5 …

• Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage ( 4.1 ) • Hypersensitivity to clopidogrel or any component of the product ( 4.2 ) 4.1 Active Bleeding Clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. …

• CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition. ( 7.1 ) • Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent. ( 7.3 ) • Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding. ( 7.4 , 7.5 , 7.6 ) • Other Antiplatelet Agents: Increases the risk of bleeding due to an additive effect. ( 7.7 ) • Repaglinide (CYP2C8 substrates): Increases substrate plasma concentrations. …

• CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole. ( 5.1 ) • Bleeding: Clopidogrel increases risk of bleeding. ( 5.2 ) • Discontinuation: Premature discontinuation increases risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. ( 5.3 ) • Thrombotic thrombocytopenic purpura (TTP) has been reported. ( 5.4 ) • Cross-reactivity among thienopyridines has been reported. ( 5.5 ) 5.1 Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. …

The following serious adverse reactions are discussed below and elsewhere in the labeling: • Bleeding [see Warnings and Precautions ( 5.2 )] • Thrombotic thrombocytopenic purpura [see Warnings and Precautions ( 5.4 )] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy 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 ]. …

Platelet inhibition by clopidogrel is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals. Based on biological plausibility, platelet transfusion may restore clotting ability.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.