Generic

Clopidogrel Bisulphate

Indications

Acute Coronary Syndrome (ACS): It is suitable for reducing the incidence of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (LA)/non-elevation myocardial infarction (NSTEMI)]. It is used to reduce the incidence of myocardial infarction and stroke in patients with acute ST-segment elevation myocardial infarction (STEMI).
Recent MI, recent stroke or established peripheral artery disease: For patients with established peripheral artery disease or recent myocardial infarction (MI) or recent stroke history, it is suitable for reducing the incidence of myocardial infarction and stroke.

Pharmacology

Dclot is a prodrug. It inhibits platelet activation and aggregation by irreversibly binding its active metabolites to P2Y12 ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be observed 2 hours after a single oral administration. A repeated daily dose of 75 mg inhibited ADP-induced platelet aggregation on the first day, and the inhibition reached a steady-state between days 3 and 7.

Dosage & Administration

Acute Coronary Syndrome: Start clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily in individuals who need an antiplatelet effect within hours. It will take several days to establish an antiplatelet effect if you start it without a loading dosage.

75 mg once a day orally without a loading dose for recent MI, recent stroke, or established peripheral arterial disease.

It is given orally with or without food.

Interaction

1. NSAIDs, warfarin, selective norepinephrine, and serotonin reuptake inhibitors (SSRIs, SNRIs): increase risk of bleeding
2. CYP2C19 inhibitors (omeprazole or esomeprazole): avoid At the same time use omeprazole or esomeprazole repaglinide (repaglinide) and combined substrate of CYP8 (repaglinide) CLOPI2) repaglinide, because it will increase the plasma concentration of repaglinide

Contraindications

Clopidogrel is contraindicated in the following situations: Allergic to any component of the drug or product. Active pathological bleeding, such as a peptic ulcer or intracranial hemorrhage.

Side Effects

Dclot is a generally well-tolerated medication.
Common side effects: bleeding, diarrhea, gastrointestinal discomfort, hemorrhage, skin reactions.
Rare side effects: acquired hemophilia, anemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Pregnancy & Lactation

There is no adequate and well-controlled study of pregnant women. It should be used during pregnancy only when clearly necessary. It is not known whether clopidogrel is excreted in human milk. The importance of the drug to the mother should be considered and a decision should be made to stop breastfeeding or discontinue the drug.

Precautions & Warnings

As it is a prodrug, its metabolism to its active metabolite is altered by genetic variations in CYP2C19 (poor metabolizer) and by drugs that inhibit CYP2C19 such as omeprazole and esomeprazole. Concomitant use with these drugs and in poor metabolizers of CYP2C19 may reduce the antiplatelet activity of clopidogrel.
Because it inhibits platelet aggregation during platelet survival (710 days), the risk of bleeding may be increased. To restore hemostasis, platelet transfusion within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
Stopping clopidogrel increases the risk of cardiovascular events. Stopping 5 days before elective surgery carries a risk of major bleeding. Resume clopidogrel as soon as hemostasis is achieved.
Thrombotic thrombocytopenic purpura (TTP) has been reported to require urgent treatment, including electrophoresis (plasma exchange).
Hypersensitivity including rash, angioedema, or haematologic reactions has been reported in patients receiving clopidogrel or a history of hypersensitivity to other thienopyridines.

Therapeutic Class

Anti-platelet drugs.

Storage Conditions

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

Pharmaceutical Name

ACME Laboratories Ltd.