Clopidogrel bisulfate, aspirin.
Each film-coated tablet contains Aspirin 75 mg and Clopidogrel (as bisulfate) equivalent to Clopidogrel 75 mg.
Pharmacology: Clopidogrel bisulfate + Aspirin (Ecosprin Plus) is a fixed-dose combination containing Aspirin and Clopidogrel. Aspirin is an antiplatelet agent. It is an acetylsalicylic acid. Aspirin acts by causing irreversible inhibition of the cyclo-oxygenase enzyme, which leads to decreased formation of Thromboxane A2. Since platelets do not synthesize new enzyme, the action of Aspirin on platelet cyclo-oxygenase is permanent, lasting for the life of the platelets (7-10 days). Clopidogrel is a thienopyridine derivative that selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the GP llb/llla complex, thereby inhibiting platelet aggregation.
Pharmacokinetics: Clopidogrel is rapidly but incompletely absorbed after oral doses; absorption appears to be at least 50%. It is a prodrug and is extensively metabolized in the liver, mainly to the inactive carboxylic acid derivative; metabolism is mediated by the cytochrome P450 isoenzymes CYP3A4 and CYP2B6, and to a lesser extent by CYP1A2, CYP1A1 and CYP2C19. The active metabolite appears to be a thiol derivative; it has been identified in vitro but appears to be too unstable to be isolated from plasma. Clopidogrel and the carboxylic acid derivative are highly protein bound. Clopidogrel and its metabolites are excreted in urine and in faeces; about 50% of an oral dose is recovered from the urine and about 46% from the faeces.
Aspirin and other salicylates are absorbed rapidly from the gastrointestinal tract when taken orally but absorption after rectal doses is less reliable. Aspirin and other salicylates can also be absorbed through the skin.
After oral doses, absorption of non-ionised aspirin occurs in the stomach and intestine. Some aspirin is hydrolyzed to salicylate in the gut wall. Once absorbed, aspirin is rapidly converted to salicylate, but during the first 20 minutes after an oral dose aspirin is the main form of the drug in the plasma. Aspirin is 80 to 90% bound to plasma proteins and is widely distributed; its volume of distribution is reported to be 170 mL/kg in adults. As plasma-drug concentrations increase, the binding sites on the proteins become saturated and the volume of distribution increases. Both aspirin and salicylate have pharmacological activity although only aspirin has an anti-platelet effect. Salicylate is extensively bound to plasma proteins and is rapidly distributed to all body parts. Salicylate appears in breast milk and crosses the placenta.
Clopidogrel bisulfate + Aspirin (Ecosprin Plus) is indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
Clopidogrel bisulfate + Aspirin (Ecosprin Plus) is given as a single tablet once a day taken with adequate water.
Or as directed by the Physician.
Hypersensitivity to Aspirin and Clopidogrel; Recent history of gastrointestinal bleeding; Active pathological bleeding such as peptic ulcer or intracranial hemorrhage or bleeding disorders like hemophilia; Patients with chicken pox, influenza or flu symptoms.
It should not be given to children, particularly those under 12 years. Aspirin may be a contributory factor in the causation of Reye's syndrome in some children. Salicylates should be used with caution in patients with a history of peptic ulceration or hemophilia and other bleeding disorders. These may also induce gastrointestinal hemorrhage. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Clopidogrel should be discontinued 7 days prior to surgery. It prolongs the bleeding time. So it should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions (particularly gastrointestinal and intraocular). Patients should be informed that it may take them longer time than usual to stop bleeding when they take this drug and they should report any unusual bleeding to the physicians. This drug should be used with caution in hepatically and renally impaired patients.
Pregnancy: Adverse effects are increased in the mother and the fetus following chronic ingestion of Aspirin. Because of possible adverse effects on the neonate and the potential for increased maternal blood loss, this drug should be avoided during the last three months of pregnancy.
Nursing Mother: As Aspirin is excreted in breast milk, this drug should be avoided in nursing mothers because of the possible risk of developing Reye's syndrome.
The combination of Aspirin and Clopidogrel is generally well tolerated. Side effects that have been reported include abdominal pain, dyspepsia, gastritis, diarrhea, nausea, vomiting, constipation, gastrointestinal hemorrhage, ulceration, neutropenia, rash, palpitation, drowsiness, asthenia, neuralgia, paresthesia and vertigo.
Coumarin anticoagulants e.g. warfarin, heparin and thrombolytic agents; NSAIDs; methotrexate; antidiabetic agents; probenecid, sulfinpyrazone, phenylbutazone; antacids. Drugs metabolized by CYP450 e.g. phenytoin, tamoxifen, tolbutamide, torsemide, fluvastatin.
Store at temperatures not exceeding 30°C. Protect from light.
B01AC30 - combinations ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Ecosprin Plus FC tab
30's (P1,050/box)
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