omitant administration of Aggrastat and unfractionated heparin. An increased risk of serious bleeding events associated with the concomitant administration of Aggrastat and enoxaparin cannot be excluded, particularly in patients given additional unfractionated heparin in conjunction with angiography and/or PCI. The efficacy of Aggrastat in combination with enoxaparin has not been established. The safety and efficacy of Aggrastat with other low molecular weight heparins has not been investigated.
There is insufficient experience with the use of tirofiban hydrochloride in the following diseases and conditions, however, an increased risk of bleeding is suspected. Therefore, tirofiban hydrochloride is not recommended in:
• Traumatic or protracted cardiopulmonary resuscitation, organ biopsy or lithotripsy within the past two weeks
• Severe trauma or major surgery >6 weeks but <3 months previously
• Active peptic ulcer within the past three months
• Uncontrolled hypertension (>180/110 mm Hg)
• Acute pericarditis
• Active or a known history of vasculitis
• Suspected aortic dissection
• Haemorrhagic retinopathy
• Occult blood in the stool or haematuria
• Thrombolytic therapy (see section 4.5).
• Concurrent use of drugs that increase the risk of bleeding to a relevant degree (see section 4.5).
There is no therapeutic experience with tirofiban hydrochloride in patients for whom thrombolytic therapy is indicated. Consequently, the use of tirofiban hydrochloride is not recommended in combination with thrombolytic therapy.
Aggrastat infusion should be stopped immediately if circumstances arise that necessitate thrombolytic therapy (including acute occlusion during PCI) or if the patient must undergo an emergency coronary artery bypass graft (CABG) operation or requires an intra-aortic balloon pump.
Paediatric population
There is no therapeutic experience with Aggrastat in children, thus, the use of Aggrastat is not recommended in these patients.
Other precautionary notes and measures
There are insufficient data regarding the re-administration of Aggrastat.
Patients should be carefully monitored for bleeding during treatment with Aggrastat. If treatment of haemorrhage is necessary, discontinuation of Aggrastat should be considered (see section 4.9). In cases of major or uncontrollable bleeding, tirofiban hydrochloride should be discontinued immediately.
Aggrastat should be used with special caution in the following conditions and patient groups:
• Recent clinically relevant bleeding (less than one year)
• Puncture of a non-compressible vessel within 24 hours before administration of Aggrastat
• Recent epidural procedure (including lumbar puncture and spinal anaesthesia)
• Severe acute or chronic heart failure
• Cardiogenic shock
• Mild to moderate liver insufficiency
• Platelet count <150,000/mm3, known history of coagulopathy or platelet function disturbance or thrombocytopenia
• Haemoglobin concentration less than 11 g/dl or haematocrit <34%.
Special caution should be used during concurrent administration of ticlopidine, clopidogrel, adenosine, dipyridamole, sulfinpyrazone, a
