Clopilet 75 mg

Description

Indications

Acute Coronary Syndrome (ACS): Clopilet is prescribed to lower the risk of myocardial infarction (MI) and stroke in individuals experiencing non-ST-segment elevation ACS, including unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI). It is also used to reduce the occurrence of MI and stroke in patients diagnosed with acute ST-elevation myocardial infarction (STEMI).

Recent Myocardial Infarction, Stroke, or Established Peripheral Arterial Disease: Clopilet is recommended for patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease to minimize the chances of MI and stroke.

Clopidogrel, the active ingredient in Clopilet, functions as a prodrug that inhibits platelet activation and aggregation. This occurs through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be observed within two hours of a single oral dose. With a daily dose of 75 mg, platelet inhibition is initiated on the first day and reaches a steady state between days 3 and 7.

Acute Coronary Syndrome: To achieve rapid antiplatelet effects, treatment is initiated with a single 300 mg oral loading dose (four tablets), followed by a maintenance dose of 75 mg once daily. Without a loading dose, the onset of antiplatelet activity may be delayed by several days.

Recent Myocardial Infarction, Stroke, or Peripheral Arterial Disease: A standard dose of 75 mg once daily is recommended without the need for a loading dose.

• Increased Bleeding Risk: Concurrent use with NSAIDs, warfarin, selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine reuptake inhibitors (SNRIs) may heighten the risk of bleeding.
• CYP2C19 Inhibitors: Avoid concomitant use with omeprazole and esomeprazole, as these may reduce the efficacy of Clopilet.
• CYP2C8 Substrates: Co-administration with repaglinide should be avoided due to increased plasma concentrations of repaglinide.

Clopilet should not be used in individuals with:

• Known hypersensitivity to clopidogrel or any of its components.
• Active pathological bleeding conditions such as peptic ulcer or intracranial hemorrhage.

Clopilet is generally well tolerated; however, some side effects may occur.

Common Side Effects: Bleeding, diarrhea, gastrointestinal discomfort, and skin reactions.

Rare Side Effects: Acquired hemophilia, anemia, angioedema, joint pain, arthritis, and bone marrow disorders.

There is insufficient data from well-controlled studies on the use of clopidogrel in pregnant women. It should only be used during pregnancy if clearly necessary. It is not known whether clopidogrel is excreted in human breast milk; therefore, a decision should be made to either discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

• Clopidogrel is a prodrug requiring metabolic activation via CYP2C19. Genetic variations in CYP2C19 metabolism (poor metabolizers) or concomitant use of CYP2C19 inhibitors (such as omeprazole and esomeprazole) may reduce its antiplatelet effect.
• Since Clopilet inhibits platelet aggregation for the platelet’s lifespan (7-10 days), it may increase bleeding risk. Platelet transfusion within 4 hours of a loading dose or 2 hours of a maintenance dose may be less effective in restoring hemostasis.
• Discontinuing Clopilet may heighten the risk of cardiovascular events. If undergoing elective surgery with a significant bleeding risk, discontinue Clopilet at least five days before the procedure and resume it as soon as hemostasis is achieved.
• Thrombotic Thrombocytopenic Purpura (TTP), requiring urgent treatment with plasmapheresis, has been reported in rare cases.
• Hypersensitivity reactions, including rash, angioedema, and hematologic reactions, have been reported in patients receiving clopidogrel or those with a history of hypersensitivity to thienopyridines.

• Pediatric Patients: Safety and effectiveness in children have not been established.
• Elderly Patients: No dosage adjustment is necessary.

An overdose of Clopilet may result in excessive bleeding. If an overdose occurs, platelet transfusion may help restore clotting function.

Antiplatelet drugs

Store below 30°C in a dry place, protected from light. Do not freeze. Keep out of the reach of children.