Generic

Clopidogrel Bisulphate

Indications

Acute Coronary Syndrome (ACS): It is used to minimize the risk of MI and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is prescribed to individuals with acute ST-elevation myocardial infarction to minimize the risk of myocardial infarction and stroke (STEMI).

Recent MI, recent Stroke, or Established Peripheral Artery Disease: It is suggested to lower the incidence of MI and stroke in patients with established peripheral arterial disease or a history of recent myocardial infarction (MI) or stroke.

Pharmacology

Clopidogrel is a prescription medication. It inhibits platelet activation and aggregation by irreversible binding of its active metabolite to platelet P2Y12 ADP receptors. Platelet aggregation can be inhibited dosage-dependently 2 hours after a single oral dose. On the first day, repeated doses of 75 mg per day reduce ADP-induced platelet aggregation, and inhibition achieves a stable state between Days 3 and 7.

Dosage & Administration

Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.

Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.

It is given orally with or without food.

Interaction

• NSAIDs, warfarin, serotonin and norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases the likelihood of bleeding
• Inhibitors of CYP2C19 (omeprazole or esomeprazole): Avoid taking omeprazole or esomeprazole at the same time.
• Clopidogrel (CYP2C8 substrates): Avoid using Clopidogrel concurrently with Repaglinide since it raises plasma concentrations of Repaglinide.

Contraindications

Clopidogrel is not recommended if you have any of the following conditions: Hypersensitivity to the medication substance or any product component. Pathological bleeding that is active, such as a peptic ulcer or cerebral hemorrhage.

Side Effects

Clopidogrel is a medication that is typically well tolerated.

• Bleeding, diarrhoea, stomach pain, haemorrhage, and skin responses are all common adverse effects.
• Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, and bone marrow abnormalities are rare adverse effects.

Pregnancy & Lactation

In pregnant women, there are no appropriate and well-controlled trials. It should only be taken during pregnancy if absolutely necessary. Clopidogrel is not known to be excreted in human breast milk. Considering the relevance of the medicine to the mother, a choice should be taken whether to cease breastfeeding or the drug.

Precautions & Warnings

• Because it is a prodrug, metabolism to its active metabolite is hampered by CYP2C19 genetic variants (poor metabolizer) and medications that block CYP2C19, such as Omeprazole and Esomeprazole. Concurrent usage with these medicines, as well as a CYP2C19 poor metaboliser, may decrease Clopidogrel's antiplatelet action.
• Because it inhibits platelet aggregation over the platelet's whole lifetime (7-10 days), the risk of bleeding may rise. Platelet transfusions within 4 hours of the loading dosage or 2 hours of the maintenance dose may be less successful in restoring hemostasis.
• Clopidogrel discontinuation raises the risk of cardiovascular events. Discontinue 5 days before elective surgery with a high risk of bleeding. Clopidogrel should be resumed as soon as hemostasis is obtained.
• TTP (Thrombotic Thrombocytopenic Purpura) has been documented, which necessitates immediate treatment, including plasmapheresis (plasma exchange).
• Patients taking clopidogrel who have a history of hypersensitivity to other thienopyridines have suffered hypersensitivity, including rash, angioedema, or hematologic response.

Therapeutic Class

Antiplatelet medications

Storage Conditions

In a dry area, keep the temperature below 30°C. Light is kept out. Do not get paralyzed. Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd