ALTEPLASE

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ALTEPLASE
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Infant Data

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MEDICAL INFORMATIONS

INDICATIONS

  • Dissolution of intravascular thrombi of recent onset that are either intraarterial or lifethreatening. Adjuvant treatment of infective endocarditis vegetations.
  • Restoration of function to central venous access devices as assessed by the ability to withdraw blood.

CONTRAINDICATIONS

  • Patients with acute ischemic stroke under the following conditions:
    • Active internal bleeding
    • Bleeding diathesis
    • Current intracranial hemorrhage
    • Hypertension that is current, severe, and uncontrolled
    • Intracranial or intraspinal surgery within the last 3 months
    • Intracranial conditions that may increase the risk of bleeding (ie, neoplasm, aneurysm, arteriovenous malformation)
    • Serious head trauma within the last 3 months
    • Subarachnoid hemorrhage
  • for the treatment of acute myocardial infarction or pulmonary embolism under the following conditions:
    • Active internal bleeding
    • Bleeding diathesis
    • Hypertension that is current, severe, and uncontrolled
    • Intracranial conditions that may increase the risk of bleeding (ie, neoplasm, aneurysm, arteriovenous malformation)
    • Recent history of stroke
    • Serious head trauma within the last 3 months

PRECAUTIONS

  • Administration:
    • Avoid noncompressible arterial, internal jugular, or subclavian punctures or IM injection.
  • Angioedema:
    • Angioedema has been reported during an up to 2 hours after administration in patients with ischemic stroke or myocardia infarction; risk may have been increased with use of concomitant ACE inhibitors.Discontinue and institute appropriate therapy if condition occurs
  • Cardiovascular:
    • Acute pericarditis or subacute bacterial endocarditi increase the risk of adverse effects.
    • Increased risk of thromboembolic events in patients with hig likelihood of left-heart thrombus(eg, mitral stenosis or atrial fibrillation).
    • Hypertensiv patients (systolic, 175 mmHg or greater; diastolic, 110 mmHg or greater) are at an increased risk of adverse effects.
    • Stroke risk ma outweigh treatment benefit in myocardial infarction patients at low risk of cardiac death.
  • Endocrine & Metabolic:
    • Cholesterol embolism has been reported with thrombolytic agents.
  • Gastrointestinal:
    • Recent gastrointestinal bleeding increases the risk of alteplase adverse effects.
  • Hematologic:
    • Fatal hemorrhage associated with traumatic intubation has occurred.
    • If treatment is initiated before coagulation test results are available, discontinue if baseline INR or aPTT elevations are seen.
    • Bleeding may occur with concurrent anticoagulant therapy, especially at arterial puncture sites.If serious bleeding develops, discontinue and treat appropriately.
    • Active internal bleeding or embolic complications may occur with venous catheter occlusion.
    • Significant or fatal internal (ie, intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory) or external bleeding have been reported; discontinue use if serious bleeding occurs.
    • Serious bleeding at critical location can occur; discontinue use.
    • Septic thrombophlebitis increases the risk of adverse effects.
    • An occluded AV cannula at a seriously infected site increases the risk of adverse effects.
    • Hemostatic defects, including defects secondary to severe renal or hepatic disease, increase the risk of adverse effects.
    • Underlying DVT may not be adequately treated in pulmonary embolism patients.
    • Increased risk of re-embolization due to lysis of underlying DVT in pulmonary embolism patients.
    • Minimize arterial and venous punctures due to an increased risk of bleeding; discontinue use if serious bleeding occurs.
    • Thrombocytopenia
  • Hepatic:
    • Significant hepatic dysfunction increases the risk of adverse effects.
  • Immunologic:
    • Hypersensitivity, including urticarial and anaphylactic reactions (eg, laryngeal edema, rash, and shock) with rare fatal outcome, have been reported; if hypersensitivity occurs, discontinue use and institute appropriate therapy.
    • Catheter infection may occur with venous catheter occlusion.
  • Neurologic:
    • Cerebrovascular disease increases the risk of adverse effects.
  • Ophthalmic:
    • Hemorrhagic ophthalmic conditions, including diabetic hemorrhagic retinopathy, increase the risk of adverse effects.
  • Renal:
    • Recent genitourinary bleeding increases the risk of adverse effects.
  • Reproductive:
    • Pregnancy may increase the risk of adverse effects.
    • Recent genitourinary bleeding may increase the risk of adverse effects.
  • Surgery:
    • Recent major surgery increases the risk of adverse effects.
  • Special Population:
    • Recent trauma increases the risk of adverse effects.

ADVERSE EFFECTS

Intracranial hemorrhage may occur, especially in premature infants treated for prolonged periods. Bleeding from venipuncture sites occurs in approximately half of treated patients.The risk of complications increases at doses above 450 mcg/kg per hour.

ADMINISTRATION

  • Restoration of function to central venous catheter: 110% of the internal lumen volume of the catheter, not to exceed 2 mg in 2 mL. Alternatively, use a smaller dose (0.5 mg diluted in NS to volume required to fill the central venous catheter).
  • Dissolution of intravascular thrombi: or further diluted in compatible diluent (in PVC bags or glass vials) to a concentration of 0.5 mg/mL.

MONITORING

Follow coagulation studies (PT, aPTT, fibrinogen, fibrin split products) prior to therapy and at least daily during treatment. Maintain fibrinogen levels greater than 100 mg/dL and platelets greater than 50,000/mm3. Echocardiography to assess clot lysis at least every 12 hours (every 6 hours optimal). Cranial ultrasound to assess for hemorrhage prior to therapy.

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