Odrel 75

Indications:

• Acute Coronary Syndrome (ACS): Recommended for reducing the risk of heart attacks and strokes in patients with non-ST-segment elevation ACS, including unstable angina and non-ST-elevation myocardial infarction (NSTEMI). Also effective in lowering the risk of these events in those with acute ST-elevation myocardial infarction (STEMI).
• Recent MI, Stroke, or Peripheral Arterial Disease: Indicated for decreasing the likelihood of heart attacks and strokes in patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease.

Pharmacology:

Clopidogrel, a prodrug, works by irreversibly binding its active metabolite to P2Y12 ADP receptors on platelets, thus inhibiting platelet activation and aggregation. This effect starts to be noticeable within 2 hours of a single dose and stabilizes after several days of continued use.

Dosage & Administration:

• For Acute Coronary Syndrome: Start with a 300 mg loading dose (4 tablets), followed by a daily dose of 75 mg. Skipping the loading dose will delay the antiplatelet effect.
• For Recent MI, Stroke, or Peripheral Arterial Disease: Administer 75 mg orally once daily, with or without food, without the need for a loading dose.

Interaction:

• Increased Bleeding Risk: When taken with NSAIDs, warfarin, SSRIs, or SNRIs.
• CYP2C19 Inhibitors: Avoid combining with omeprazole or esomeprazole as they may interfere with the drug’s effectiveness.
• Repaglinide: Concomitant use with Repaglinide is not recommended due to increased plasma levels of Repaglinide.

Contraindications:

• Hypersensitivity to clopidogrel or any component of the product.
• Active pathological bleeding, including peptic ulcer or intracranial hemorrhage.

Side Effects:

• Common: Bleeding, gastrointestinal discomfort, diarrhea, skin reactions.
• Rare: Acquired hemophilia, anemia, angioedema, bone marrow disorders.

Pregnancy & Lactation:

• Use during pregnancy only if necessary, as no adequate studies are available.
• The excretion of clopidogrel in human breast milk is unknown; consider discontinuing either the drug or nursing.

Precautions & Warnings:

• Genetic variations in CYP2C19 or the use of CYP2C19 inhibitors may impair the drug’s metabolism, reducing its effectiveness.
• As clopidogrel inhibits platelet aggregation for 7-10 days, there is an increased risk of bleeding, especially in surgical contexts.
• Discontinuing clopidogrel raises the risk of cardiovascular events; stop 5 days before major surgery and resume once hemostasis is achieved.
• Thrombotic Thrombocytopenic Purpura (TTP) has been reported and requires immediate treatment.
• Be cautious in patients with a history of hypersensitivity to clopidogrel or other thienopyridines.

Use in Special Populations:

• Not established for pediatric use.
• No dose adjustment needed for elderly patients.

Overdose Effects:

• Overdose may result in bleeding complications. Platelet transfusion could potentially restore clotting ability.

Therapeutic Class:

Anti-platelet drugs

Storage Conditions:

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