Pladex 75

Generic

Clopidogrel Bisulphate

 

Indications

Acute Coronary Syndrome (ACS): Non-ST-segment elevation ACS has been shown to reduce the incidence of myocardial infarction (MI) and stroke in patients with unstable angina (UA)/non-ST-segment elevation myocardial infarction (NSTEMI). It has been shown 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 arterial disease: has been shown to reduce the incidence of MI and stroke in patients with established peripheral arterial disease or a history of recent myocardial infarction (MI) or recent stroke.

 

Pharmacology

Pladex is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of the ADP receptor on platelets. Dose-dependent inhibition of platelet aggregation can be observed 2 hours after single oral doses. Repeated doses of 75 mg daily inhibited ADP-induced platelet aggregation on day 1, and inhibition reached steady-state from day 3 to day 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 the 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.

 

Interactions

• Non-steroidal anti-inflammatory drugs, warfarin, selective serotonin, and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): increase the risk of bleeding
• CYP2C19 inhibitors (omeprazole or esomeprazole) ): Avoid the simultaneous use of omeprazole or esomeprazole
• Repaglinide (using CYP8C substrate at the same time) clopidogrel and clopidogrel. Repaglinide, because it increases the plasma concentration of Repaglinide

 

Contraindications

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

 

Side Effects

• Clopidogrel is a commonly tolerated drug.
• Common side effects: bleeding, diarrhea, gastrointestinal discomfort, bleeding, skin reactions.
• Rare side effects: acquired hemophilia, anemia, angioedema, arthralgia, arthritis, bone marrow disorders.

 

Pregnancy

There are no adequate and well-controlled studies on pregnant women. It should only be used during pregnancy when clearly needed. It is not known whether Pladex is excreted in human milk. A decision should be made to either discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

 

Precautions

• Since it is a prodrug, the metabolism of its active metabolites is affected by CYP2C19 (weak metabolizer) gene mutations and drugs that inhibit CYP2C19 (such as omeprazole and esomeprazole). Simultaneous use of these drugs and CYP2C19 weak metabolizers may reduce the antiplatelet activity of clopidogrel.
•  Because it inhibits platelet aggregation during the entire life cycle (710 days) of platelets, it may increase the risk of bleeding. In order to restore hemostasis, platelet transfusion within 4 hours after the loading dose or within 2 hours after the maintenance dose may be less effective.
•  Discontinuation of clopidogrel increases the risk of cardiovascular events. If you stop 5 days before the elective surgery, you have a higher risk of bleeding. Clopidogrel treatment was resumed immediately after hemostasis.
•  Thrombotic purpura (TTP) requires emergency treatment, including plasma exchange (plasma exchange) has been reported.
•  In patients receiving clopidogrel or patients with a history of allergies to other thienopyridines, allergies have been reported, including skin rash, angioedema, or hematological reactions.

 

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

UniMed UniHealth Pharmaceuticals Ltd.

 

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