Norepinephrine bitartrate

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

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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)

• Norepinephrine Bitartrate Injection is a concentrated, potent drug which must be diluted in dextrose containing solutions prior to infusion. An infusion of LEVOPHED should be given into a large vein.

Restoration of Blood Pressure in Acute Hypotensive States

• Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intraaortic pressures must be maintained to prevent cerebral or coronary artery ischemia, LEVOPHED can be administered before and concurrently with blood volume replacement.

• Diluent

• LEVOPHED should be diluted in 5 percent dextrose injection or 5 percent dextrose and sodium chloride injections. These dextrose containing fluids are protection against significant loss of potency due to oxidation. Administration in saline solution alone is not recommended. Whole blood or plasma, if indicated to increase blood volume, should be administered separately (for example, by use of a Y-tube and individual containers if given simultaneously).

• Average Dosage

• Add a 4 mL ampul (4 mg) of LEVOPHED to 1,000 mL of a 5 percent dextrose containing solution. Each mL of this dilution contains 4 mcg of the base of LEVOPHED. Give this solution by intravenous infusion. Insert a plastic intravenous catheter through a suitable bore needle well advanced centrally into the vein and securely fixed with adhesive tape, avoiding, if possible, a catheter tie-in technique as this promotes stasis. An IV drip chamber or other suitable metering device is essential to permit an accurate estimation of the rate of flow in drops per minute. After observing the response to an initial dose of 2 mL to 3 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation to vital organs. In previously hypertensive patients, it is recommended that the blood pressure should be raised no higher than 40 mm Hg below the preexisting systolic pressure. The average maintenance dose ranges from 0.5 mL to 1 mL per minute (from 2 mcg to 4 mcg of base).

• High Dosage

• Great individual variation occurs in the dose required to attain and maintain an adequate blood pressure. In all cases, dosage of LEVOPHED should be titrated according to the response of the patient. Occasionally much larger or even enormous daily doses (as high as 68 mg base or 17 ampuls) may be necessary if the patient remains hypotensive, but occult blood volume depletion should always be suspected and corrected when present. Central venous pressure monitoring is usually helpful in detecting and treating this situation.

• Fluid Intake

• The degree of dilution depends on clinical fluid volume requirements. If large volumes of fluid (dextrose) are needed at a flow rate that would involve an excessive dose of the pressor agent per unit of time, a solution more dilute than 4 mcg per mL should be used. On the other hand, when large volumes of fluid are clinically undesirable, a concentration greater than 4 mcg per mL may be necessary.

• Duration of Therapy

• The infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy. Infusions of LEVOPHED should be reduced gradually, avoiding abrupt withdrawal. In some of the reported cases of vascular collapse due to acute myocardial infarction, treatment was required for up to six days.

Adjunctive Treatment in Cardiac Arrest

• Infusions of LEVOPHED are usually administered intravenously during cardiac resuscitation to restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. LEVOPHED’s powerful beta-adrenergic stimulating action is also thought to increase the strength and effectiveness of systolic contractions once they occur.

• Average Dosage

• To maintain systemic blood pressure during the management of cardiac arrest, LEVOPHED is used in the same manner as described under Restoration of Blood Pressure in Acute Hypotensive States.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
• Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
• Avoid contact with iron salts, alkalis, or oxidizing agents.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Cardiopulmonary Bypass Operation

• Combined bi-atrial infusion of low-dose alprostadil and norepinephrine facilitates weaning from cardiopulmonary bypass of cardiac-surgery patients who developed acute pulmonary hypertension and low cardiac output syndrome post-operatively.

• Dosing Information

• Starting dose of alprostadil was 20 ng/kg/min, with incremental doses of 5 ng/kg/min over 5 min to maintain mean pulmonary artery pressure below 30 mmHg.
• Norepinephrine was started at 0.08 mcg/kg/min and titrated to a final dose of 0.11 mcg/kg/min.

Upper Gastrointestinal Hemorrhage

• Norepinephrine by intragastric administration was demonstrated to halt upper GI bleeding. Norepinephrine was given through a nasogastric tube at a dose of 8 mg in 100 mL of normal saline or 16 mg in 200 mL of normal saline.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients has not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

• Levophed®

Look-Alike Drug Names

• Levophed® — Levofloxacin

Drug Shortage Status

Price

References

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

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