ACI ORS Oral Powder
IV Infusion
Radiant Pharmaceuticals Ltd.Generic:
AlteplaseWeight:
1 mg/1 mlbest Price:
৳50000.00Generic
Alteplase
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.
Pharmacology
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 regimens Pulmonary 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.
Dosage Administration
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 regimens Pulmonary 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.
Side Effects
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.
Pregnancy And Lactation
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.
Therapeutic
The following adverse reactions are: Bleeding Orolingual Angioedema Cholesterol Embolization Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism.
Storage Conditions
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.
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