Last reviewed · How we verify
Levophed (Norepinephrine Bitartrate)
Peripheral vasoconstrictor via alpha-adrenergic action and cardiac inotropic stimulator with coronary vasodilation via beta-adrenergic action.
Norepinephrine bitartrate is a catecholamine indicated for raising blood pressure in adult patients with severe, acute hypotension through dual alpha and beta-adrenergic mechanisms. It has a short half-life of 2.4 minutes and achieves steady-state plasma concentration within 5 minutes of intravenous infusion. Significant drug interactions exist with MAO inhibitors, tricyclic antidepressants, and halogenated anesthetics, requiring careful monitoring. Close hemodynamic and cardiac monitoring is essential during administration, particularly in patients on interacting medications.
At a glance
| Generic name | Norepinephrine Bitartrate |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Catecholamine, sympathomimetic amine |
| Target | Alpha-adrenergic and beta-adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Mechanism of action
Norepinephrine bitartrate is a catecholamine that acts as a peripheral vasoconstrictor through alpha-adrenergic receptor stimulation, resulting in increased blood pressure. Simultaneously, it functions as an inotropic stimulator of the heart through beta-adrenergic action, enhancing cardiac contractility and coronary blood flow. These dual mechanisms make it effective for restoring blood pressure in acute hypotensive states.
Approved indications
- Severe, acute hypotension in adult patients
- Acute hypotensive states in adult patients
- Blood pressure restoration in adult patients
Common side effects
- Hypertension
- Bradycardia
- Tissue Ischemia
- Hypotension
- Cardiac Arrhythmias
- Anxiety
- Headache
- Transient Headache
- Respiratory Difficulty
- Pulmonary Edema
- Ischemic Injury
- Extravasation Necrosis at Injection Site
Drug interactions
- Monoamine oxidase (MAO) inhibitors and MAO-inhibiting drugs (e.g., linezolid)
- Tricyclic antidepressants (amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine)
- Antidiabetic drugs
- Halogenated anesthetics (cyclopropane, desflurane, enflurane, isoflurane, sevoflurane)
Key clinical trials
- Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences (PHASE4)
- Early Norepinephrine in Trauma Patients With Hemorrhagic Shock (PHASE1, PHASE2)
- Early Administration of Norepinephrine in Sepsis (PHASE4)
- Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure (PHASE3)
- Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy (PHASE3)
- Effects of Vasopressor on the Graft Blood Flow in TRAM (NA)
- Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension (PHASE4)
- Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 12097170 | 2041-03-08 | Formulation |
| 11413259 | 2038-01-30 | Formulation |
| 10420735 | 2038-01-30 | Formulation |
| 10226436 | 2038-01-30 | Formulation |
| 10568850 | 2038-01-30 | Formulation |
| 12245996 | 2038-01-30 | Formulation |
| 10159657 | 2038-01-30 | Formulation |
| 12290494 | 2041-03-08 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |