NORPLAT-S Tablet

- For the reduction of thrombotic events in patients with recent myocardial infarction, recent stroke, or established peripheral arterial disease.

- Prophylactically in patients at risk of thromboembolic disorders such as myocardial infarction, peripheral arterial disease and stroke.

- For acute coronary syndrome (unstable angina-non-Q-wave MI).

Dosage and Administration

This tablet can be administered with or without food.

The recommended dose is 1 tablet daily.

This tablet has been administered for up to 1 year.

In patients:

- who have shown hypersensitivity to clopidogrel, aspirin or any component of the product.

- with active gastro-duodenal ulcers,

- with hypersensitivity to salicylates (bronchospasm, anaphylactic reactions),

- with haemorrhagic disease,

- with severe hepatic function impairment,

- who are pregnant,

- who are lactating.

Gastrointestinal disturbances: Diarrhea, abdominal pain, indigestion, nausea and heart burn.

Dermatological reactions: Rash, pruritus.

Nephritic ion reactions: Edema, urticaria, asthma.

Following adverse effects were reported rarely:

Increase bleeding tendency, gastrointestinal bleeding, gastric ulcers, severe neutropenia or agranulocytosis, thrombocytopenia, thrombotic thrombocytopenic purpura, aplastic anemia, membranous nephropathy with nephritic syndrome, loss of taste, acute arthritis.

(See the package insert about details.)

Anticoagulants, coumarin, heparin or thrombolytic agents

NSAIDs

Methotrexate

Antidiabetic agents

Uricosuric agents

Antacids

Warfarin

Drugs metabolized by CYP450

Contraindicated.

Clopidogrel:

Renal Insufficiency: After repeated doses of 75mg clopidogrel per day, plasma levels of the main circulating metabolite were lower in patients with severe renal impairment (creatinine clearance 5 -15 mL/min) compared to subjects with moderate renal impairment (creatinine clearance 30-60mL/min) or healthy subjects. However the prolongation of bleeding time was similar. No dose adjustment is required in mild to moderate renal impaired patients.

Full blood count should be performed before starting treatment with this medicine and every 2 weeks during the first 3 months of therapy. If clopidogrel is discontinued during this period, a full blood count should be performed within 2 weeks of stopping treatment.

Aspirin should be used with caution in

- children or teenagers with chickenpox, influenza or fever.

- patients who are allergic to ibuprofen or other NSAID medicines.

- patients with chronic or recurrent stomach or duodenal ulcers or digestive hemorrhages.

- patients with severe renal disease.

- patient suffering from allergic diseases like asthma or urticaria.

- patients suffering from gout.

Clopidogrel should be used with caution

- in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions.

- if a patient is to undergo elective surgery, consideration should be given to stopping clopidogrel 5 days before surgery.

- in patient who have lesions with a propensity to bleed (such as ulcers). Drugs that might induce such lesions should be used in caution in patients taking clopidogrel.

Hepatic Impaired Patients

Renal Impaired Patients

This medicine should be used with caution in such patients. (see the package insert about details.)

Clopidogrel

Clopidogrel is an inhibitor of platelet aggregation, that is, a drug that inhibits the ability of platelets to clump together as part of a blood clot.

It appears to act by blocking the adenosine phosphate (ADP) receptors, which prevents fibrinogen binding to the receptor. This decreases the ability of platelet adhesion and aggregation. Clopidogrel is a prodrug and requires biotransformation to produce inhibition of platelet aggregation.

Aspirin:

Acetylsalicylic acid inhibits the activity of the enzyme cyclo-oxygenase and thus prostaglandins and thromboxane formation are decreased. By blocking thromboxane synthesis, acetylsalicylic acid inhibits rapidly the platelet aggregation; this action is irreversible. Acetylsalicylic acid may also inhibit formation of prostacyclin, a platelet aggregation inhibitor; this action is reversible.