Actilyse IV Infusion
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Indications
Acute Ischemic Stroke: Alteplase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment. Initiate treatment as soon as possible but within 3 hours after symptom onset.Acute Myocardial Infarction: Alteplase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and the reduction of the incidence of heart failure.Pulmonary Embolism: Alteplase is indicated for the lysis of acute massive pulmonary embolism, defined as:
Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments.
Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.
Interaction
The interaction of Alteplase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Alteplase therapy. In the post-marketing setting, there have been reports of orolingual angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors.
Contraindications
Acute Ischemic Stroke: Do not administer Alteplase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1)]:
Current intracranial hemorrhage
Subarachnoid hemorrhage
Active internal bleeding
Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
Presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms)
Bleeding diathesis
Current severe uncontrolled hypertension.
Acute Myocardial Infarction or Pulmonary Embolism: Do not administer Alteplase for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit:
Active internal bleeding
History of recent stroke
Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma
Presence of intracranial conditions that may increase the risk of bleeding (e.g. some neoplasms, arteriovenous malformations, or aneurysms)
Bleeding diathesis
Current severe uncontrolled hypertension.
Side Effects
The following adverse reactions are:
Bleeding
Orolingual Angioedema
Cholesterol Embolization
Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary
Embolism.
Dosage
Acute Ischemic Stroke: Administer Alteplase as soon as possible but within 3 hours after onset of symptoms. The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose), with 10% of the total dose administered as an initial intravenous bolus over 1 minute and the remainder infused over 60 minutes. During and following Alteplase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure. In patients without recent use of oral anticoagulants or heparin, Alteplase treatment can be initiated prior to the availability of coagulation study results. Discontinue Alteplase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated.Acute Myocardial Infarction: Administer Alteplase as soon as possible after the onset of symptoms. The recommended total doses for acute myocardial infarction (AMI) is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hour). There are two Alteplase dose regimens (accelerated and 3-hour) for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimensPulmonary Embolism (PE): The recommended dose is 100 mg administered by IV infusion over 2 hours. Institute parenteral anticoagulation near the end of or immediately following the Alteplase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less.
Administration
Following bolus dose, if indicated:
50 mg vials: administer using either a polyvinyl chloride bag or glass vial and infusion set.
100 mg vials: remove from the vial any quantity of drug in excess of that specified for patient treatment. Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Alteplase. Peel the clear plastic hanger from the vial label. Hang the Alteplase vial from the resulting loop.
Alteplase is for intravenous administration only. Extravasation of Alteplase infusion can cause ecchymosis or inflammation. If extravasation occurs, terminate the infusion at that IV site and apply local therapy. Do not add any other medication to infusion solutions containing Alteplase.
Pregnancy Cat
Pregnancy Category C. Alteplase is embryocidal in rabbits when intravenously administered in doses of approximately two times (3 mg/kg) the human dose for AMI. No maternal or fetal toxicity was evident at 0.65 times (1 mg/kg) the human dose in pregnant rats and rabbits dosed during the period of organogenesis. There are no adequate and well-controlled studies in pregnant women. It is not known whether Alteplase is excreted in human milk. Many drugs are excreted in human milk.
Precautions
Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. If serious bleeding occurs, discontinue Alteplase.
Monitor patients during and for several hours after infusion for orolingual angioedema. If angioedema develops, discontinue Alteplase.
Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents.
Consider the risk of reembolization from the lysis of underlying deep venous thrombi in patients with pulmonary embolism.
Overdose Effects
n/a
Drug Classes
Anti-platelet drugs, Fibrinolytics (Thrombolytics)
Storage Conditions
Store lyophilized Alteplase at controlled room temperature not to exceed 30°C, or under refrigeration (2-8°C). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C, Alteplase may be used within 8 hours following reconstitution. Discard any unused solution after administration is complete. Do not use beyond the expiration date stamped on the vial.
Composition
n/a
Mode Of Action
Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. This initiates local fibrinolysis with limited systemic proteolysis.Pharmacodynamics: Following administration of 100 mg Alteplase, there is a decrease (16%-36%) in circulating fibrinogen. In a controlled trial, 8 of 73 patients (11%) receiving Alteplase (1.25 mg/kg body weight over 3 hours) experienced a decrease in fibrinogen to below 100 mg/dL.Pharmacokinetics: Alteplase in acute myocardial infarction (AMI) patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. There is no difference in the dominant initial plasma half-life between the 3-hour and accelerated regimens for AMI. The plasma clearance of alteplase is 380-570 mL/min, primarily mediated by the liver. The initial volume of distribution approximates plasma volume.
Reconstitution
n/a
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