Clocard-A (Clopidogrel 75 mg + Aspirin 75 mg)
Therapeutic Group : Cardiovascular
Presentation:
Clocard- A Tablet: Each film coated tablet contains Clopidogrel Bisulfate USP equivalent to Clopidogrel 75 mg and Aspirin BP 75 mg.
Pharmacology:
Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPllb/lIla complex, thereby inhibiting platelet aggregation. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP. 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.
Indications:
Clocard-A is indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
Dosage & Administration:
The recommended dose is one tablet of Clocard-A daily or as directed by the physicians.
Contrainidications:
The use of Clopidogrel & Aspirin is contraindicated in hypersensitivity to the drug substance or any component of the product, a recent history of
gastrointestinal bleeding and active pathological bleeding such as a peptic ulcer or intracranial hemorrhage.
Warning & Precautions:
Aspirin may be a contributory factor in the causation of Reyes 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 & Aspirin 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.
Side effects:
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, paraesthesia and vertigo.
Drug interaction:
Clopidogrel & Aspirin combination should not be administered simultaneously with other salicylate containing preparations, uricosuric
agents or NSAIDs. Oral anticoagulants, Glycoprotein IIb/IIIa inhibitors, Injectable anticoagulants, Eptifibatide, Ticlopidine, Tirofiban, Thrombolytics, Nicorandil, Methotrexate, Acetazolamide, SSRIs, Levothyroxine, Valproic Acid etc. may increase the bleeding tendency. Alcohol may increase the risk of gastrointestinal injury when taken with Aspirin. Therefore, alcohol should be used with caution in patients taking Aspirin.
Use in special groups:
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. There were no adequate and well controlled studies of Clopidogrel in pregnant women. It should be used during pregnancy only if clearly needed. Lactation: 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. It is not known whether Clopidogrel is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing woman. Pediatric use: Safety and efficacy have not been established in pediatric patients. Geriatric use: Dosage adjustment based solely on age does not appear to be necessary in geriatric patients. Renal impairment: This drug should be used with caution in renal impaired patients. Hepatic Impairment: This drug should be used with caution in hepatic impaired patients.
Packing:
Clocard-A Tablet: Each box contains 30 tablets in Alu-Alu blister pack.
