Plax

Plax

clopidogrel

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Concise Prescribing Info
Contents
Clopidogrel
Indications/Uses
Secondary prevention of atherothrombotic events in MI (few days until <35 days), ischaemic stroke (7 days until <6 mth) or established peripheral arterial disease. Acute coronary syndrome: In combination w/ acetylsalicylic acid (ASA) for non-ST segment elevation (unstable angina or non-Q-wave MI) including patients undergoing stent placement following percutaneous coronary intervention & ST segment elevation acute MI in medically treated patients eligible for thrombolytic therapy. 75 mg: In combination w/ ASA for prevention of atherothrombotic & thromboembolic events in atrial fibrillation including stroke.
Dosage/Direction for Use
Adult & elderly 75 mg single daily dose. Non-ST elevation (unstable angina or non-Q-wave MI) Initially 300 mg as single loading dose then continue at 75 mg once daily w/ ASA 75-235 mg daily. ST segment elevation acute MI 75 mg single daily dose initiated w/ 300 mg loading dose in combination w/ ASA & w/ or w/o thrombolytics. Atrial fibrillation 75 mg single daily dose w/ ASA 75-100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Severe hepatic impairment.
Special Precautions
History of hypersensitivity to thienopyridines eg, ticlopidine or prasugrel. Discontinue use in patients w/ confirmed diagnosis of acquired haemophilia. Not recommended during 1st 7 days after acute ischaemic stroke. Increased risk of bleeding from trauma, surgery or other pathological conditions; GI & intraocular lesions w/ propensity to bleed; thrombotic thrombocytopenic purpura. Patients w/ genetically reduced CYP22C19 function. Discontinue use 7 days prior to elective surgery. Not recommended in concomitant use w/ oral anticoagulants. Concomitant use w/ ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDS including COX-2 inhibitors, SSRIs or other medicinal products associated w/ bleeding risk eg, pentofylline; strong or moderate CYP2C19 inhibitors, CYP2C8 substrates. Renal impairment. Moderate hepatic impairment w/ bleeding diatheses. Not to be used during pregnancy & lactation. Not to be used in childn.
Adverse Reactions
Haematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; puncture site bleeding.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk, oral anticoagulants, ASA, heparin, SSRIs. Increased occult GI blood loss w/ NSAIDs including COX-2 inhibitors. Reduced drug levels by strong or moderate CYP2C19 inhibitors eg, omeprazole, esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, efavirenz. Increased plasma conc w/ CYP2C8 substrates eg, repaglinide, paclitaxel. Glycoprotein IIb/IIIa inhibitors, thrombolytics.
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Plax FC tab 300 mg
Packing/Price
10 × 10's;100 × 10's;3 × 10's;50 × 10's
Form
Plax FC tab 75 mg
Packing/Price
10 × 10's;100 × 10's;3 × 10's;50 × 10's
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