Odrel Plus

Indications:

• Acute Coronary Syndrome (ACS): Prescribed to lower the incidence of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina or non-ST-elevation myocardial infarction) and ST-segment elevation ACS (ST-elevation myocardial infarction).
• Recent MI, Stroke, or Peripheral Arterial Disease: Effective in reducing the risk of MI and stroke in individuals with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.

Pharmacology:

• Clopidogrel: This prodrug inhibits platelet activation and aggregation through irreversible binding to the P2Y12 ADP receptors. Noticeable effects begin within 2 hours of administration, with steady-state inhibition achieved by Day 3 to Day 7.
• Aspirin: Works by irreversibly inhibiting platelet cyclooxygenase, preventing thromboxane A2 formation, which is crucial for platelet aggregation and vasoconstriction.
• Pharmacokinetics: Clopidogrel is rapidly absorbed, with peak plasma levels reached about 1 hour post-dose. It is extensively metabolized in the liver. The main metabolite, which does not affect platelet aggregation, constitutes approximately 85% of the drug-related compounds in plasma.

Dosage & Administration:

• Acute Coronary Syndrome: Begin treatment with a 300 mg loading dose of Clopidogrel, followed by a daily maintenance dose of 75 mg. Combination with Aspirin (75 mg-325 mg daily) is recommended.
• Recent MI, Stroke, or Peripheral Arterial Disease: Administer 75 mg of Clopidogrel daily, with or without food, without a loading dose.

Interactions:

• Increased Bleeding Risk: May occur when combined with NSAIDs, warfarin, SSRIs, or SNRIs.
• CYP2C19 Inhibitors: Avoid using with omeprazole or esomeprazole, as they may impair Clopidogrel’s effectiveness.
• Repaglinide: Concurrent use is not advised due to increased plasma levels.

Contraindications:

• Hypersensitivity: To Clopidogrel or any component of the product.
• Active Pathological Bleeding: Includes conditions like peptic ulcers or intracranial hemorrhage.

Side Effects:

• Common: Includes bleeding, gastrointestinal discomfort, diarrhea, and skin reactions.
• Rare: May involve acquired hemophilia, anemia, angioedema, and bone marrow disorders.

Pregnancy & Lactation:

• Pregnancy: Should be used only if clearly necessary during the first and second trimesters. Contraindicated in the third trimester.
• Lactation: Clopidogrel’s presence in breast milk is unknown; however, Aspirin is known to be excreted. Discontinue breastfeeding during treatment.

Precautions & Warnings:

• Bleeding Risk: Prolonged bleeding time is possible.
• Thrombotic Thrombocytopenic Purpura (TTP): Rarely reported; requires prompt treatment.
• Reye’s Syndrome: Risk in children with chickenpox or flu-like symptoms.
• Hypersensitivity: Includes rash, angioedema, or hematologic reactions.

Use in Special Populations:

• Children: Not recommended, especially under 12 years, due to the risk of Reye’s syndrome.

Overdose Effects:

• Clopidogrel Overdose: May cause bleeding complications; platelet transfusion might help.
• Aspirin Overdose: Symptoms include dizziness, headache, and gastrointestinal issues; severe cases may require hemodialysis.

Therapeutic Class:

• Anti-platelet drugs

Storage Conditions:

• Store below 30°C, in a cool, dry place, away from light and moisture. Keep out of reach of children.