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ABCIXIMAB · by ELI LILLY

ANTITHROMBOTIC AGENTS Antiplatelet, Antithrombotic drugs; glycoproteinIIB/IIIA inhibitors ELI LILLY

Composition

Inj: Per ml: Abciximab 2 mg; 5 ml soln.

Indications & Dosage

Prevention of ischaemic cardiac complications in patients undergoing percutaneous coronary intervention: BY IV INJ OR INF: Adults: 0.25 mg/ kg by bolus IV inj. 10-60 min prior to PTCA and immediately followed by a 0.125 mcg/kg/min. continuous IV INF for 12 hr. Short-term prevention of myocardial infarction in patients with unstable angina not responding to conventional treatment and who are scheduled for percutaneous coronary intervention: BY IV INJ OR INF: Adults: 0.25 mg/kg by bolus IV inj up to 24 hr prior to PTCA and immediately followed by a 0.125 mcg/kg/min. continuous IV INF for 12 hr after the intervention. Elderly: Over 80 yr, not recommended. Children: Not recommended.

Administration

For intravenous infusion: Give continuously in Glucose 5% or Sodium Chloride 0.9%. Dilute requisite dose in infusion fluid andgive via infusion pump; filter upon dilution through a non pyrogenic low protein binding 0.2, 0.22, or 5 micron filteror upon administration through an in-line non-progeniclow protein-binding 0.2 or 0.22 micron filter. Administer oral aspirin at a dose of not less than 300 mg daily. Administer Heparin in a low-dose weight adjusted regimen: see literature.

Contraindications

Active internal bleeding, arteriovenous malformation or aneurysm, haemorrhagic diathesis, hypertensive retinopathy, intracranial neoplasm, intracranial or intraspinal surgery or trauma within last 2 months, major surgery within last 2 months, severe hypertension, stroke within last 2 years, thrombocytopenia, vasculitis.

Precautions

Hepatic impairment; avoid in severe liver disease increased risk of bleeding. Renal impairment; caution in severe impairment increased risk of bleeding, peripheral vascular disease, risk of anaphylaxis. Measure baseline prothrombin time, activated clotting time, activated partial thromboplastin time, platelet count, haemoglobin and haematocrit. Monitor haemoglobin and haematocrit 12 hours and24 hours after start of treatment and platelet count2-4 hours and 24 hours after start of treatment,transfuse platelets if count drops below 50,000 cells/microliters. Cardio-pulmonary resuscitation facilities must be available. Pretreat with an H2 antagonist to prevent gastro-intestinal bleeding.

Interactions

Caution with concomitant use of drugsthat increase risk of bleeding. Additive effects with thrombolytics, anticoagulants, anti platelet agents

Pregnancy

Risk cannot be ruled out, use only if potential benefit outweighs risk

Lactation

Caution advised or effect undetermined.

Side Effects

Bleeding, chest pain, bradycardia, fever, headache, hypotension, nausea, back pain, thrombocytopenia, vomiting. Rare: Adult respiratory distress, cardiac tamponade, hypersensitivity reactions.