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AGGRASTAT

TIROFIBAN · by ATCO

ANTITHROMBOTIC AGENTS Antiplatelet, Antithrombotic drugs; glycoprotein Iib/Iiia inhibitors ATCO

Composition

Inj: Per ml: Tirofiban (ashydrochloride monohydrate) 0.25 mg, 50ml (12.5 mg) solution; vial.

Indications & Dosage

Prevention of early myocardial infarction in patients with unstable angina or non-ST-segment-elevation myocardial infarction (NSTEMI) with last episode of chest pain within 12 hours: BY IV INF: Adult: With angiography planned for 4-48 hours after diagnosis: Initially 400 nanograms/kg/min for 30 minutes, then 100 nanograms/kg/min for at least48 hrs, continue for 12-24 hours after percutaneous coronary intervention, max. duration of treatment 48 hours. Use in combination with unfractionated heparin, aspirin, and Clopidogrel: BY IV INJ: Adult: With angiographywithin 4 hours of diagnosis: Initially 25 mcg/kg, over 3 min at start of percutaneous coronary intervention, then (by IV INF) 150 nanograms/kg/minute for12-24 hours, max. duration of treatment 48 hours, use in combination with unfractionated heparin, aspirin, and Clopidogrel. For reduction of major cardiovascular events in patients with ST-segment elevation myocardial infarction (STEMI) intended for primary percutaneous coronary intervention (PCI): BY IV INJ: Adult: 25 mcgm/kg, over 3 min at start of percutaneous coronary intervention, then (by IV INF) 150 nanograms/kg/minute for12-24 hours, max. duration of treatment 48 hours, use in combination with unfractionated heparin, aspirin, and Clopidogrel. Children: Notrecommended.

Administration

For IV infusion, give continuously in Glucose 5% or Sodiumchloride 0.9%. Withdraw 50ml infusion fluid from 250mlbag and replace with 50ml tirofiban concentrate(250 micrograms/ml) to give a final concentration of50 micrograms/ml. Infuse over 30 min. (premixedsolution does not require dilution). Unused solution should be discarded. Do not administer via the same IV line as di-azepam.

Compatibility

Stable in D5 VAS, D5W, NS. Tirofiban may be administered in the same IV line as heparin, dopamine, lidocaine, potassium chloride and famotidine injection, incompatible with diazepam.

Stability

Store at 25C (77F). Do not freeze. Protect from light during storage.

Contraindications

History of aneurysm, history of arteriovenous malformation, history of haemorrhagic stroke, history of intracranial disease, history of neoplasm, increased INR, increased prothrombin time, severe hypertension, stroke within 30 days . thrombocytopenia, haemorrhage within last 30 days, malignant hypertension, trauma or major surgery within last 6 weeks, platelet function disorders, clotting disturbances, severe liver failure.

Precautions

Severe renal failure, protracted cardiopulmonary resuscitation, organ biopsy or lithotripsy within last 2 weeks, active peptic ulcer within 3 months, uncontrolled hypertension, acute pericarditis, vasculitis, aortic dissection, haemorrhagic retinopathy, haematuria, occult blood in stools, significant bleeding within last year, recent epidural, severe acute or chronic heart failure, cardiogenic shock, mild to moderate liver impairment, anaemia, female, elderly or low body weight patients. Withdraw immediately if patient requires thrombolytic therapy or a coronary artery bypass graft. Monitor for haemorrhage; withdraw immediately if cannot be controlled. Monitor blood counts and APTT before and during therapy. Monitor platelet count within 1 hour if previously received GPIlb/Illa antagonist; risk of acute and severe thrombocytopenia, under specialist supervision.

Interactions

Thrornbolytics within last 48 hours, anticoagulants and other GPIib/Iiia inhibitors, LMWHs, ticlopidine, clopidogrel, adenosine, dipyridamole, sulfinpyrazone, prostacyclin, dextran solutions and diazepam infusion.

Pregnancy

Contraindicated

Lactation

Not recommended.

Side Effects

Bleeding manifestations, fever, headache, nausea, reversible thrombocytopenia, decrease in platelet counts, rash and severe allergic reactions.