| a) Generic Name |
Clopidogrel bisulphate INN & Aspirin BP
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| b) Trade/Brand Name |
To be submitted at the time of inclusion.
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| a) Presentation |
TABLET.
Each tablet contains Clopidogrel bisulphate INN equivalent to Clopidogrel 75 mg & Aspirin BP 75 mg.
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| b) Indications |
Clopiogrel and Aspirin is indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
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| c) Dosage & administration |
The recommended dosage is one tablet once daily. If necessary, the dosage may be increased to two tablets daily. The dosage however should be individualized.
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| d) Contraindications |
• Hypersensitivity to Clopidogrel
• Hypersensitivity to Aspirin and/or non-steroidal anti-inflammatory agents
• Recent history of gastrointestinal bleeding
• Active pathological bleeding such as peptic ulcer or intracranial hemorrhage, or bleeding disorders like hemophilia
|
| e) Side Effects
|
The drug 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, syncope, drowsiness, asthenia, neuralgia, paresthesia and vertigo.
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| f) Warnings & Precautions
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As with other anti-platelet agents, Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Clopidogrel should be discontinued 7 days prior to surgery.
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| g) Use in Pregnancy : |
This combination should be used during pregnancy only if the expected benefit outweighs the potential foetal risk.
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| h) Use in Lactation |
This combination should be avoided in nursing mothers because of the possible risk of developing Reye's syndrome. Regular use of high doses of Aspirin could impair platelet function and produce hypoprothrombinemia in infants if neonatal vitamin K levels are low.
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| i)Drug Interactions |
Aspirin : Oral anticoagulants, enalapril, ACE inhibitors, analgesics, antidepressants, cytotoxics.
Clopidogrel : NSAIDs, heparin, warfarin, drugs metabolized by cytochrome P-450 system, dipyridamole.
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| j) Paediatric Use |
Safety and effectiveness of the combination in the pediatric population have not been established yet.
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| k) Storage |
Store in a cool & dry place.
Keep out of the reach of children.
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| l) Package Quantity |
Box containing 5 X 10 Tablets in blister pack.
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