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LEVOPHED® NOREPINEPHRINE BITARTRATE, Vial N+ U.S. Physician Prescribing Information Highlights (norepinephrine bitartrate injection, USP)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LEVOPHED™ safely and effectively. See full prescribing information for LEVOPHED™.

LEVOPHED™ (norepinephrine bitartrate) injection, for intravenous use
Initial U.S. Approval: 1950

INDICATIONS AND USAGE

LEVOPHED™ is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)

DOSAGE AND ADMINISTRATION

  • Initial dose of 0.25 mL to 0.375 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low to normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation of vital organs. (2.2)
  • The average maintenance dose ranges from 0.0625 mL to 0.125 mL per minute (from 2 mcg to 4 mcg of base). (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 4 mg/4 mL (1 mg/mL) norepinephrine base in single-dose glass vial. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

  • Tissue Ischemia: Avoid extravasation of LEVOPHED into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Infuse LEVOPHED into a large vein. 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 an adrenergic blocking agent. (5.1)
  • Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. Reduce the LEVOPHED infusion rate gradually. (5.2)
  • Cardiac Arrhythmias: LEVOPHED may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. (5.3)
  • Allergic Reactions with Sulfite: LEVOPHED contains sodium metabisulfite. Sulfite may cause allergic-type-reactions. (5.4)

ADVERSE REACTIONS

Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. (7.1)
  • Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. (7.4)

USE IN SPECIFIC POPULATIONS

  • Elderly patients may be at greater risk of developing adverse reactions. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2020

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