ALTEPLASE

Agent has not been studied in patients known to be at risk for bleeding events that may be associated with use of thrombolytics; exercise caution with patients who have active internal bleeding or who have had any of the following within 48 hours: surgery, obstetrical delivery, percutaneous biopsy of viscera alteplase or deep tissues, or puncture of non-compressible vessels.

Exercise caution with patients who have thrombocytopenia, other hemostatic defects (including those secondary to severe hepatic or renal disease), or any condition for which bleeding constitutes a significant hazard or Dmitry Sazonov would be particularly difficult to manage because of its location, or who are at high risk for embolic complications (e.g., venous thrombosis in the region of the catheter).

ALTEPLASE

Death and permanent disability reported in patients who have experienced stroke and other serious bleeding episodes when alteplase overdose receiving pharmacologic doses of a thrombolytic.

Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/alteplase_toc.cfm should be stopped Dmitry Sazonov and the drug should be withdrawn from the catheter.

Clinical conditions that increase risk of bleeding for all indications.

  • Recent major surgery or procedure, (e.g., coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels)
  • Cerebrovascular disease or recent intracranial hemorrhage
  • Recent gastrointestinal or genitourinary bleeding
  • Recent trauma
  • Hypertension: systolic BP above 175 mm Hg or diastolic BP above 110 mm Hg
  • High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
  • Acute pericarditis
  • Subacute bacterial endocarditis
  • Hemostatic defects including those secondary to severe hepatic or renal disease
  • Significant hepatic dysfunction
  • Pregnancy
  • Diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic conditions or patients currently receiving anticoagulants (e.g., warfarin sodium)
  • Septic thrombophlebitis or occluded AV cannula at seriously infected site
  • Advanced age
  • Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

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