Clorel^® A

Clorel^®-A is a fixed-dose combination containing Clopidogrel and Aspirin. Clopidogrel is an inhibitor of platelet aggregation. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP mediated activation of the glycoprotein GPllb/ Illa complex, thereby inhibiting platelet aggregation. Aspirin is also an antiplatelet agent. Aspirin acts by causing irreversible inhibition of the cyclooxygenase enzyme, which leads to decreased formation of thromboxane A2. Since platelets do not synthesise new enzyme, the action of aspirin on platelet cyclooxygenase is permanent, lasting for the life of the platelets (7-10 days).

Clorel"-A is indicated for the prevention of ischaemic events myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.

Clorel^®-A is indicated for the prevention of ischaemic events myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.

The recommended dose is one tablet once daily.

Adverse effects are increased in the mother and the foetus following chronic ingestion of aspirin. Because of possible adverse effects on the neonate and the potential for increased maternal blood loss, Clorel^®-A should be avoided during the last three months of pregnancy.

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Precautions: Clorel^®-A should be used cautiously in case of Thrombotic Thrombocytopenic Purpura (TTP), GI bleeding, Raye's syndrome, nasal polyps or nasal allergies. As with other antiplatelet 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, Clorel^®-A should be discontinued 7 days prior to surgery.

Hepatic or Renal Impairment: Clorel®-A should be avoided in patients with impaired hepatic and renal function. Aspirin causes sodium and water retention in patients with renal impairment and increases the risk of gastrointestinal bleeding.

Nursing mothers: Clorel®-A should be avoided in nursing mothers because of the possible risk of developing reye's syndrome in foetus.

Paediatric use: Safety and effectiveness of Clorel®-A in the paediatric population have not been established.

The drug is generally well tolerated. Side effects that have been reported include abdominal pain, dyspepsia, gastritis, diarrhoea, nausea, vomiting, constipation, gastrointestinal hemorrhage, ulceration, neutropenia, rash, palpitation, syncope, drowsiness, asthenia, neuralgia, paresthesia and vertigo.

Hypersensitivity to Clopidogrel, hypersen­sitivity to Aspirin and/or nonsteroidal anti-inflammatory agents, recent history of gastrointestinal bleeding, active pathological bleeding such as peptic ulcer or intracranial hemorrhage, or bleeding disorders like haemophilia.

Oral anticoagulants: Clorel^®-A should be used with caution when anticoagulants are prescribed concurrently because it increases bleeding lime. Nonsteroidal Anti­Inflammatory Drugs (NSAIDs): NSAIDs and Clopidogrel should be co-administered with caution. Clorel^®-A is contraindicated in patients who are hypersensitive to NSAIDs.

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Store in a cool and dry place. Protect from light.

Clorel^®-A Tablet: Each coated tablet contains Clopidogrel 75 mg as Bisulphate INN and Aspirin BP 75 mg.

Clorel^®-A Tablet: Carton of 30 tablets in blister.