Norepinephrine bitartrate: Difference between revisions

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Important


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<i><span style="color:#FF0000;">ConditionName: </span></i>
<i><span style="color:#FF0000;">Antidote for Extravasation Ischemia: </span></i>


* Content
* To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.


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Revision as of 14:37, 24 July 2014

Norepinephrine bitartrate
Black Box Warning
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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Black Box Warning

Important
See full prescribing information for complete Boxed Warning.
Antidote for Extravasation Ischemia:
  • To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Overview

Norepinephrine bitartrate is a vasopressor that is FDA approved for the {{{indicationType}}} of acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). Norepinephrine is also indicated as an adjunct in the treatment of cardiac arrest and profound hypotension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bradyarrhythmia, hypertension, extravasation injury, necrosis, nausea, vomiting, confusion, headache, tremor, anxiety, restlessness, and urinary retention.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • 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 Norepinephrine bitartrate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norepinephrine bitartrate 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 Norepinephrine bitartrate 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 Norepinephrine bitartrate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Norepinephrine bitartrate in pediatric patients.

Contraindications

  • Condition1

Warnings

Important
See full prescribing information for complete Boxed Warning.
Antidote for Extravasation Ischemia:
  • To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of Regitine® (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Norepinephrine bitartrate 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 Norepinephrine bitartrate 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 Norepinephrine bitartrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Norepinephrine bitartrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Norepinephrine bitartrate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Norepinephrine bitartrate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Norepinephrine bitartrate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Norepinephrine bitartrate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Norepinephrine bitartrate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Norepinephrine bitartrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Norepinephrine bitartrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Norepinephrine bitartrate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Norepinephrine bitartrate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Norepinephrine bitartrate in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Norepinephrine bitartrate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Norepinephrine bitartrate in the drug label.

Pharmacology

There is limited information regarding Norepinephrine bitartrate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Norepinephrine bitartrate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Norepinephrine bitartrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Norepinephrine bitartrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Norepinephrine bitartrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Norepinephrine bitartrate in the drug label.

How Supplied

Storage

There is limited information regarding Norepinephrine bitartrate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Norepinephrine bitartrate in the drug label.

Precautions with Alcohol

  • Alcohol-Norepinephrine bitartrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

  • Levophed® — Levofloxacin[2]

Drug Shortage Status

Price

References

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

  1. ↑ "LEVOPHED (norepinephrine bitartrate) injection, solution, concentrate".
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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