Khrizvix

Khrizvix

clopidogrel

Manufacturer:

Fredun Pharmaceuticals

Distributor:

Khriz Pharma
Concise Prescribing Info
Contents
Clopidogrel bisulfate
Indications/Uses
Adults suffering from MI (from a few days until <35 days), ischaemic stroke (from 7 days until <6 mth) or established peripheral arterial disease. In combination w/ ASA for non-ST segment elevation including patients undergoing a stent placement following percutaneous coronary intervention or for ST-segment elevation acute MI in medically treated patients eligible for thrombolytic therapy. In combination w/ ASA for the prevention of atherothrombotic & thromboembolic events including stroke in adults w/ atrial fibrillation who have at least 1 risk factor for vascular events, not suitable for treatment w/ vit K antagonists & has a low bleeding risk.
Dosage/Direction for Use
Adult & elderly 75 mg as a single dose. Patient suffering from non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave MI) Initially 300 mg as a single loading dose then continued at 75 mg once daily. Patient suffering from ST segment elevation acute MI Initially 300 mg as a single loading dose in combination w/ ASA & w/ or w/o thrombolytics then continued at 75 mg as a single daily dose. Patient >75 yr Initiate therapy w/o a loading dose. Atrial fibrillation 75 mg as a single daily dose + ASA 75-100 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to clopidogrel bisulfate, or to soya or peanut oil. Active pathological bleeding eg, peptic ulcer or intracranial haemorrhage. Severe hepatic impairment.
Special Precautions
Cross-reactions among thienopyridines. Consider acquired haemophilia in cases of confirmed isolated aPTT prolongation w/ or w/o bleeding. Not recommended during the 1st 7 days of acute ischaemic stroke. Patients who are poor CYP2C19 metabolisers. Rarely, TTP. Consider blood cell count determination &/or other appropriate testing whenever clinical symptoms suggestive of bleeding arise during the course of treatment. Concomitant use w/ CYP2C8 substrates. Renal & moderate hepatic impairment. Do not use during pregnancy. Lactation. Not to be used in childn.
Adverse Reactions
Hematoma; epistaxis; GI haemorrhage, diarrhoea, abdominal pain, dyspepsia; bruising; bleeding at puncture site.
Drug Interactions
Increased risk of bleeding w/ medicinal products associated w/ bleeding risk. Increased occult GI blood loss w/ naproxen. Affect platelet activation & increase risk of bleeding w/ SSRIs. Reduced drug levels w/ CYP2C19 inhibitors. Decreased exposure w/ omeprazole. Glycoprotein IIb/IIIa inhibitors.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Khrizvix FC tab 75 mg
Packing/Price
30's
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