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=====Acute Myocardial Infarction=====
=====Acute Myocardial Infarction=====


* Dosing Information
:* Dosage
=====Acute Ischemic Stroke=====


* '''''A dose of 150 mg of activase should not be used for the treatment of acute myocardial infarction because it has been associated with an increase in intracranial bleeding.'''''
* '''''A dose of 150 mg of activase should not be used for the treatment of acute myocardial infarction because it has been associated with an increase in intracranial bleeding.'''''


* Dosing Information
* '''Accelerated Infusion'''
 
:* Accelerated Infusion


::* The recommended total dose is based upon patient weight, not to exceed 100 mg. For patients weighing > 67 kg, the recommended dose administered is 100 mg as a 15 mg intravenous bolus, followed by 50 mg infused over the next 30 minutes, and then 35 mg infused over the next 60 minutes.
:* The recommended total dose is based upon patient weight, not to exceed 100 mg. For patients weighing > 67 kg, the recommended dose administered is 100 mg as a 15 mg intravenous bolus, followed by 50 mg infused over the next 30 minutes, and then 35 mg infused over the next 60 minutes.


::* For patients weighing ≤ 67 kg, the recommended dose is administered as a 15 mg intravenous bolus, followed by 0.75 mg/kg infused over the next 30 minutes not to exceed 50 mg, and then 0.50 mg/kg over the next 60 minutes not to exceed 35 mg.
:* For patients weighing ≤ 67 kg, the recommended dose is administered as a 15 mg intravenous bolus, followed by 0.75 mg/kg infused over the next 30 minutes not to exceed 50 mg, and then 0.50 mg/kg over the next 60 minutes not to exceed 35 mg.


::* The safety and efficacy of this accelerated infusion of Alteplase regimen has only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL PHARMACOLOGY.
:* The safety and efficacy of this accelerated infusion of Alteplase regimen has only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL PHARMACOLOGY.


::* a. The bolus dose may be prepared in one of the following ways:
:: a. The bolus dose may be prepared in one of the following ways:


::* By removing 15 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.
:* By removing 15 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.
By removing 15 mL from a port (second injection site) on the infusion line after the infusion set is primed.
By removing 15 mL from a port (second injection site) on the infusion line after the infusion set is primed.
By programming an infusion pump to deliver a 15 mL (1 mg/mL) bolus at the initiation of the infusion.
By programming an infusion pump to deliver a 15 mL (1 mg/mL) bolus at the initiation of the infusion.


::* b. The remainder of the Activase dose may be administered as follows:
:: b. The remainder of the Activase dose may be administered as follows:
 
:* 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.


::* 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.
:* 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.


::* 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
* '''3-Hour Infusion'''


:* 3-Hour Infusion
:* The recommended dose is 100 mg administered as 60 mg in the first hour (of which 6 to 10 mg is administered as a bolus), 20 mg over the second hour, and 20 mg over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours, as described above, may be used.15


::* The recommended dose is 100 mg administered as 60 mg in the first hour (of which 6 to 10 mg is administered as a bolus), 20 mg over the second hour, and 20 mg over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours, as described above, may be used.15
:* Although the value of the use of anticoagulants during and following administration of Activase has not been fully studied, heparin has been administered concomitantly for 24 hours or longer in more than 90% of patients.


::* Although the value of the use of anticoagulants during and following administration of Activase has not been fully studied, heparin has been administered concomitantly for 24 hours or longer in more than 90% of patients.
:* Aspirin and/or dipyridamole have been given to patients receiving Alteplase during and/or following heparin treatment.


::* Aspirin and/or dipyridamole have been given to patients receiving Alteplase during and/or following heparin treatment.
:: a. The bolus dose may be prepared in one of the following ways:


::* a. The bolus dose may be prepared in one of the following ways:
:* By removing 6 to 10 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.


::* By removing 6 to 10 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.
:* By removing 6 to 10 mL from a port (second injection site) on the infusion line after the infusion set is primed.
By removing 6 to 10 mL from a port (second injection site) on the infusion line after the infusion set is primed.
By programming an infusion pump to deliver a 6 to 10 mL (1 mg/mL) bolus at the initiation of the infusion.
By programming an infusion pump to deliver a 6 to 10 mL (1 mg/mL) bolus at the initiation of the infusion.


::* b. The remainder of the Activase dose may be administered as follows:
:: b. The remainder of the Activase dose may be administered as follows:
 
:* 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.
 
:* 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
 
=====Acute Ischemic Stroke=====
 
 
 
* Dosing Information


::* 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.


::* 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
xx


=====Pulmonary Embolism=====
=====Pulmonary Embolism=====

Revision as of 20:48, 13 July 2014

Alteplase (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Overview

Alteplase (injection) is a thrombolytic agent that is FDA approved for the {{{indicationType}}} of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI. Alteplase is also indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability and the management of acute massive pulmonary embolism (PE) in adults. Common adverse reactions include hemorrhage.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Myocardial Infarction
  • A dose of 150 mg of activase should not be used for the treatment of acute myocardial infarction because it has been associated with an increase in intracranial bleeding.
  • Accelerated Infusion
  • The recommended total dose is based upon patient weight, not to exceed 100 mg. For patients weighing > 67 kg, the recommended dose administered is 100 mg as a 15 mg intravenous bolus, followed by 50 mg infused over the next 30 minutes, and then 35 mg infused over the next 60 minutes.
  • For patients weighing ≤ 67 kg, the recommended dose is administered as a 15 mg intravenous bolus, followed by 0.75 mg/kg infused over the next 30 minutes not to exceed 50 mg, and then 0.50 mg/kg over the next 60 minutes not to exceed 35 mg.
  • The safety and efficacy of this accelerated infusion of Alteplase regimen has only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL PHARMACOLOGY.
a. The bolus dose may be prepared in one of the following ways:
  • By removing 15 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.

By removing 15 mL from a port (second injection site) on the infusion line after the infusion set is primed. By programming an infusion pump to deliver a 15 mL (1 mg/mL) bolus at the initiation of the infusion.

b. The remainder of the Activase dose may be administered as follows:
  • 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.
  • 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
  • 3-Hour Infusion
  • The recommended dose is 100 mg administered as 60 mg in the first hour (of which 6 to 10 mg is administered as a bolus), 20 mg over the second hour, and 20 mg over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours, as described above, may be used.15
  • Although the value of the use of anticoagulants during and following administration of Activase has not been fully studied, heparin has been administered concomitantly for 24 hours or longer in more than 90% of patients.
  • Aspirin and/or dipyridamole have been given to patients receiving Alteplase during and/or following heparin treatment.
a. The bolus dose may be prepared in one of the following ways:
  • By removing 6 to 10 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device.
  • By removing 6 to 10 mL from a port (second injection site) on the infusion line after the infusion set is primed.

By programming an infusion pump to deliver a 6 to 10 mL (1 mg/mL) bolus at the initiation of the infusion.

b. The remainder of the Activase dose may be administered as follows:
  • 50 mg vials—administer using either a polyvinyl chloride bag or glass vial and infusion set.
  • 100 mg vial—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 Activase. Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
Acute Ischemic Stroke
  • Dosing Information


xx

Pulmonary Embolism
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Alteplase (injection) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alteplase (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Alteplase (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Alteplase (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alteplase (injection) in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Alteplase (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Alteplase (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alteplase (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Alteplase (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Alteplase (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Alteplase (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Alteplase (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Alteplase (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Alteplase (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Alteplase (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Alteplase (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Alteplase (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Alteplase (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Alteplase (injection) in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Alteplase (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Alteplase (injection) in the drug label.

Pharmacology

There is limited information regarding Alteplase (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Alteplase (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Alteplase (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Alteplase (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Alteplase (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Alteplase (injection) in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Alteplase (injection) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Alteplase (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Alteplase (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Alteplase (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Alteplase (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Activase®[1]
  • Cathflo Activase®[2]

Look-Alike Drug Names

  • Cathflo Activase® — Activase®[3]
  • Cathflo Activase® — TNKase®[3]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "ACTIVASE (alteplase) kit".
  2. ↑ "CATHFLO ACTIVASE (alteplase) injection, powder, lyophilized, for solution".
  3. ↑ 3.0 3.1 "http://www.ismp.org". External link in |title= (help)


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