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  • Aggrastat
    / Tzamal

    Active Ingredient

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Infusion Bag

    1 X 12.5 mg / 250 ml

    partial basket chart 78669 9277


    1 X 12.5 mg / 50 ml

    partial basket chart 78670


    AGGRASTAT Injection must first be diluted to the same strength as this product Injection Premixed, as noted under Directions for Use.
    Use with Aspirin and Heparin: In the clinical studies, patients received aspirin, unless it was contraindicated, and heparin. This product and heparin can be administered through the same intravenous catheter.
    Precautions: This product is intended for intravenous delivery using sterile equipment and technique. Do not add other drugs or remove solution directly from the bag with a syringe. Do not use plastic containers in series connections; such use can result in air embolism by drawing air from the first container if it is empty of solution. Any unused solution should be discarded.
    Recommended Dosage: In most patients, AGGRASTAT should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. Patients with severe renal insufficiency (creatinine clearance <30 mL/min) should receive half the usual rate of infusion.
    No dosage adjustment is recommended for elderly or female patients. In PRISM-PLUS, AGGRASTAT was administered in combination with heparin for 48 to 108 hours. The infusion should be continued through angiography and for 12 to 24 hours after angioplasty or atherectomy.
    For full details see prescribing information.


    Aggrastat, in combination with heparin, is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischemic events and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery.
    Aggrastat has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure.


    Aggrastat is contraindicated in patients with:
    • known hypersensitivity to any component of the product;
    • active internal bleeding or a history of bleeding diathesis within the previous 30 days;
    • a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous
    malformation, or aneurysm;
    • a history of thrombocytopenia following prior exposure to Aggrastat;
    • a history of stroke within 30 days or any history of hemorrhagic stroke;
    • major surgical procedure or severe physical trauma within the previous month;
    • history, symptoms, or findings suggestive of aortic dissection;
    • severe hypertension (systolic blood pressure >180 mmHg and /or diastolic blood pressure >110 mmHg;
    • concomitant use of another parenteral GP llb/llla inhibitor;
    • acute pericarditis.

    Special Precautions

    Bleeding Precautions: Percutaneous Coronary Intervention – Care of the femoral artery access site: Therapy with this product is associated with increases in bleeding rates particularly at the site of arterial access for femoral sheath placement. Care should be taken when attempting vascular access that only the anterior wall of the femoral artery is punctured. Prior to pulling the sheath, heparin should be discontinued for 3-4 hours and activated clotting time (ACT) <180 seconds or APTT <45 seconds should be documented. Care should be taken to obtain proper hemostasis after removal of the sheaths using standard compressive techniques followed by close observation. While the vascular sheath is in place, patients should be maintained on complete bed rest with the head of the bed elevated 30° and the affected limb restrained in a straight position. Sheath hemostasis should be achieved at least 4 hours before hospital discharge.
    Minimize Vascular and Other Trauma: Other arterial and venous punctures, epidural procedures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation and nasogastric tubes should be minimized. When obtaining intravenous access, non-compressible sites (e.g., subclavian or jugular veins) should be avoided.
    Laboratory Monitoring: Platelet counts, and hemoglobin and hematocrit should be monitored prior to treatment, within 6 hours following the loading infusion, and at least daily thereafter during therapy with this product (or more frequently if there is evidence of significant decline). In patients who have previously received GP IIb/IIIa receptor antagonists, consideration should be given to earlier monitoring of platelet count. If the patient experiences a platelet decrease to <90,000/mm³, additional platelet counts should be performed to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, this product and heparin should be discontinued and the condition appropriately monitored and treated.
    For full details see prescribing information.

    Side Effects

    In clinical trials, 1946 patients received this product in combination with heparin and 2002 patients received this product alone. Duration of exposure was up to 116 hours. 43% of the population was >65 years of age and approximately 30% of patients were female. BLEEDING The most common drug-related adverse event reported during therapy with this product when used concomitantly with heparin and aspirin, was bleeding (usually reported by the investigators as oozing or mild).
    For full details see prescribing information.

    Drug interactions

    AGGRASTAT has been studied on a background of aspirin and heparin.The use of this product, in combination with heparin and aspirin, has been associated with anincrease in bleeding compared to heparin and aspirin alone Caution should be employed when used with other drugs that affect hemostasis (e.g., warfarin). No information is available about the concomitant use with thrombolytic agents  In a sub-set of patients (n=762) in the PRISM study, the plasma clearance of tirofiban in patients receiving one of the following drugs was compared to that in patients not receiving that drug. There were no clinically significant effects of co-administration of these drugs on the plasma clearance of tirofiban: acebutolol, acetaminophen, alprazolam, amlodipine, aspirin preparations, atenolol, bromazepam, captopril, diazepam, digoxin, diltiazem, docusate sodium, enalapril, furosemide, glyburide, heparin, insulin, isosorbide, lorazepam,lovastatin,metoclopramide, metoprolol, morphine, nifedipine, nitrate preparations, oxazepam, potassium chloride, propranolol, ranitidine, simvastatin, sucralfate and temazepam. Patients who received levothyroxine or omeprazole along with this product had a higher rate of clearance of this product. The clinical significance of this is unknown.

    Pregnancy and Lactation

    Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.
    Nursing Mothers: It is not known whether tirofiban is excreted in human milk. However, significant levels of tirofiban were shown to be present in rat milk. Because many drugs are excreted in human milk, and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
    See prescribing information for full details.


    In clinical trials, inadvertent overdose with this product occurred in doses up to 5 times and 2 times the recommended dose for bolus administration and loading infusion, respectively. Inadvertent overdose occurred in doses up to 9.8 times the 0.15 mcg/kg/min maintenance infusion rate. The most frequently reported manifestation of overdose was bleeding, primarily minor mucocutaneous bleeding events and minor bleeding at the sites of cardiac catheterization Overdose of this product  should be treated by assessment of the patient’s clinical condition and cessation or adjustment of the drug infusion as appropriate. This product can be removed by hemodialysis.

    Baxter Healthcare Corp. USA