Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets)

1. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) © The Swiss Pharmacy

2. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Clopivas (Generic Clopidogrel Bisulfate tablets) is used to treat patients with Acute coronary syndrome. 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. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. This medicine is also used to treat patients with recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. © The Swiss Pharmacy

3. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Clopivas Tablets are manufactured by Cipla Limited, India in the strength of 75 mg and 300 mg. © The Swiss Pharmacy

4. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Chemical Structure © The Swiss Pharmacy

5. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) The active ingredient contained in Clopivas tablets is Clopidogrel Bisulfate. Each film-coated Clopivas tablet contains Clopidogrel Bisulfate eqivalent to 75 mg or 300 mg of Clopidogrel. © The Swiss Pharmacy

6. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Uses of Clopivas 75 mg and 300 mg Tablets: Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) are used alone or together with aspirin to lessen the chance of a heart attack or stroke. It is given to patients with acute coronary syndrome (ACS), to patients who have already had a heart attack, severe chest pain, or a stroke, or to patients with other circulation problems (eg, peripheral arterial disease) that could cause a stroke or heart attack. Acute coronary syndrome is a condition where the blood flow to the heart is blocked. A heart attack or stroke may occur when a blood vessel is blocked by a blood clot. Clopidogrel is a platelet inhibitor. It reduces the chance that a harmful blood clot will form by preventing platelets from clumping together in the blood. Clopidogrel may also increase the chance of serious bleeding in some people. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

7. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Recommended Adult Dosage Acute Coronary Syndrome: Acute Coronary Syndrome: Clopivas tablets Clopivas tablets (Generic Clopidogrel Bisulfate tablets) can be administered with or without food. For patients with non-ST-elevation ACS (UA/NSTEMI), initiate with a single oral loading dose of Clopivas 300 and then continue at Clopivas 75 once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with Clopivas. For patients with STEMI, the recommended dose is Clopivas 75 once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopivas may be initiated with or without a loading dose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

8. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Recommended Adult Dosage Recent MI, Recent Stroke or Established PAD: Recent MI, Recent Stroke or Established PAD: The recommended dose is Clopivas 75 once daily orally, with or without food. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

9. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Contraindications ➔Clopivas is contraindicated in patients with a known hypersensitivity to Clopidogrel Bisulfate or any component of the tablet. ➔Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

10. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Storage Instructions Clopivas (Generic Clopidogrel Bisulfate tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

11. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Warnings Reduced effectiveness in impaired CYP2C19 function: Avoid concomitant use with medicines that are strong or moderate CYP2C19 inhibitors (e.g., Omeprazole). Bleeding: Clopidogrel tablets increases risk of bleeding. Discontinue 5 days prior to elective surgery. Discontinuation of Clopidogrel tablets: Premature discontinuation of Clopivas increases risk of cardiovascular events. Recent transient ischemic attack or stroke: Combination use of Clopidogrel tablets and Aspirin in these patients was not shown to be more effective than Clopivas tablets alone, but was shown to increase major bleeding. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

12. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Warnings Thrombotic thrombocytopenic purpura (TTP): TTP has been reported with Clopidogrel Bisulfate tablets, including fatal cases. Patients should be evaluated for history of hypersensitivity to another thienopyridine (such as Ticlopidine, Prasugrel) since cross-reactivity among thienopyridines has been reported. Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological reactions such as thrombocytopaenia and neutropaenia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

13. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Warnings As with other antiplatelet agents, when considering prescribing Clopidogrel, physicians should inquire whether the patient has a history of bleeding. Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from recent trauma, surgery or other pathological condition(s), and in patients receiving treatment with acetylsalicylic acid, heparin, glycoprotein IIb/IIIa inhibitors, non- steroidal anti-inflammatory drugs (NSAIDs), or selective serotonin reuptake inhibitors (SSRIs). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

14. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Possible Side Effects Bleeding, including life-threatening and fatal bleeding, is the most commonly reported side effect. Another serious side effect is Thrombotic thrombocytopenic purpura. Some other side effects that were reported include – thrombocytopenia, leucopenia, neutropenia (including severe neutropenia), granulocytopenia, anemia, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel), paresthesia, dizziness, vertigo, abdominal pain, dyspepsia, gastritis, vomiting, nausea, constipation, flatulence, gynecomastia, glomerulonephritis, hematuria. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

15. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Possible Side Effects The following side effects were reported post marketing: Blood and Lymphatic System Disorders: Agranulocytosis, aplastic anemia/pancytopenia, TTP, acquired hemophilia A Eye Disorders: Eye (conjunctival, ocular, retinal) bleeding Gastrointestinal Disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis , gastric/duodenal ulcer, diarrhea General Disorders and Administration Site Conditions: Fever, hemorrhage of operative wound Hepato-Biliary Disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test Immune System Disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

16. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Possible Side Effects The following side effects were reported post marketing: Musculoskeletal, Connective Tissue and Bone Disorders: Musculoskeletal bleeding, myalgia, arthralgia, arthritis Nervous System Disorders: Taste disorders, fatal intracranial bleeding, headache Psychiatric Disorders: Confusion, hallucinations Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia Renal and Urinary Disorders: Increased creatinine levels Skin and Subcutaneous Tissue Disorders: Maculopapular or erythematous rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized pruritus Vascular Disorders: Vasculitis, hypotension URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

17. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Clopivas Tablets Overdosage Platelet inhibition by Clopidogrel (Clopivas tablets) 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 1,500 or 2,000 mg/kg was lethal to mice and to rats and at 3,000 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

18. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Treatment of Clopivas Tablets Overdosage Based on biological plausibility, platelet transfusion may restore clotting ability URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

19. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Clopivas Tablets During Pregnancy Clopidogrel Bisulfate (Clopivas tablets) has been classified by the US FDA as Pregnancy Category B. Reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis), revealed no evidence of impaired fertility or fetotoxicity due to Clopidogrel. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, Clopidogrel (Clopivas tablets) should be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy

20. Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) Clopivas Tablets Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html © The Swiss Pharmacy