Clogrel Plus Tablet

Clogrel Plus Tablet is used for: Acute coronary syndrome, TIA, Ischaemic events, MI, Stroke

Adult: PO Prevention of ischaemic events Per tab contains clopidogrel 75 mg and aspirin 75 mg: 1 tab once daily. Acute coronary syndrome Per tab contains clopidogrel 75 mg and aspirin 75 mg: Loading dose: 4 tab; maintenance: 1 tab/day.

Renal impairment: CrCl (ml/min) <10 Avoid use.

Should be taken with food.

Hypersensitivity to aspirin, NSAIDs or clopidogrel; active peptic ulceration; children <12 yr; patients with haemophilia or haemorrhagic disorders; gout; severe renal or hepatic impairment; lactation.

History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal lesion or heavy ethanol consumption; asthma or allergic disorders; tinnitus; dehydrated patients; uncontrolled hypertension; impaired renal or hepatic function; children and elderly; pregnancy. Patients at risk of increased bleeding from trauma, surgery, or other pathological conditions. Increased risk of Reye's syndrome when used in patients with chicken pox, influenza or flu symptoms. Caution when used in patients with nasal allergies or nasal polyps. For patients undergoing elective surgery and an antiplatelet effect is not needed, clopidogrel should be discontinued 7-10 days before surgery.

Pregnancy Aspirin Avoid chronic or intermittent high doses during pregnancy; may affect maternal and newborn hemostasis mechanisms, leading to an increased risk of hemorrhage. High doses may also increase perinatal mortality by intrauterine growth restriction and teratogenic effects. Near term, aspirin may prolong gestation and labor. Premature closure of the ductus arteriosus may occur if used near term with the use of full-dose aspirin. Clopidogrel Available data from cases reported over two decades in published literature and postmarketing surveillance have not identified any drug-associated risks for major birth defects or miscarriage; there are risks to pregnant woman and fetus associated with myocardial infarction and stroke Myocardial infarction and stroke are medical emergencies; therapy for pregnant woman should not be withheld because of potential concerns regarding effects of clopidogrel on the fetus Labor or delivery Therapy during labor or delivery will increase risk of maternal bleeding and hemorrhage; avoid neuraxial blockade during clopidogrel use because of risk of spinal hematoma; when possible, discontinue therapy 5-7 days prior to labor, delivery, or neuraxial blockade Animal data Embryo-fetal development studies performed showed no evidence of fetotoxicity when drug administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose Lactation Aspirin Drug enters breast milk; a decision should be made regarding whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Clopidogrel There are no data on the presence of the drug in human milk or its effects on milk production; no adverse effects on breastfed infants were observed during lactation in a small number of postmarketing cases; studies in rats have shown that clopidogrel and/or its metabolites are present in milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition Clopidogrel PREGNANCY avoid—no information available. BREASTFEEDING advises to avoid.

Aspirin: Corticosteroids, phenylbutazone and oxyphenbutazone may increase risk of GI ulceration. Use with coumarins, anagrelide, agatroban, LMWH, bivalirudin, dasatinib, iloprost, lepirudin and tenecteplase may increase the risk of bleeding. Clopidogrel: Co-administration of clopidogrel with NSAIDs may increase the risk of stomach and intestinal bleeding. There is an increased risk of bleeding with coumarins, agatroban, dasatinib, heparin, LMWH, gingko biloba and iloprost. Increased risk of bleeding if clopidogrel and drotrecogin alfa are given within 7 days. May increase bupropion level and side effects (lightheadedness , GI discomfort). Potentially Fatal: Aspirin and clopidogrel: Increased risk of bleeding with dabigatran.

Side effects of Aspirin + Clopidogrel : Aspirin: GI disturbances, epigastric discomfort, prolonged bleeding time, rhinitis, urticaria; angioedema, salicylism, tinnitus. Clopidogrel: Dyspepsia, abdominal pain, nausea, vomiting, flatulence, constipation, gastritis, gastric and duodenal ulcers. Serious events include bleeding and GI hemorrhage. GI upset, diarrhea, paraesthesia, vertigo, headache, dizziness, leucopaenia, eosinophilia, rash and pruritus. Potentially Fatal: Aspirin: Gastric erosion, ulceration and bleeding; severe, occasionally fatal exacerbation of airway obstruction in asthma; Reye's syndrome (child <12 yrs). Hepatotoxicity; CNS depression, which may lead to coma; CV collapse, resp failure; paroxysmal bronchospasm and dyspnoea. Clopidogrel: Bleeding disorders including GI intracranial hemorrhage and thrombotic thrombocytopenic purpura.

Aspirin inhibits the formation of thromboxane A2 in the platelets. This inhibits platelet aggregation and coagulation. This action lasts until the enzyme cyclo-oxygenase is regenerated in the platelets. Clopidogrel is a prodrug and is metabolised an active thiol metabolite. The active metabolite selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GP IIb/IIIa complex, thereby inhibiting platelet aggregation.

Clogrel Plus 75mg + 75mg Tablet manufactured by Ad-din Pharmaceuticals Ltd.. Its generic name is Aspirin + Clopidogrel. Clogrel Plus is availble in Bangladesh. Farmaco BD drug index information on Clogrel Plus Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.