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LEVOPHED®(norepinephrine bitartrate injection, USP)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
LEVOPHED® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Correct...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 4 mg/4 mL (1 mg/mL norepinephrine base) sterile, colorless solution in a single-dose amber glass vial.
Injection: 4 mg/4 mL (1 mg/mL norepinephrine base) sterile, colorless...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Tissue Ischemia
Administration of LEVOPHED to patients who are hypotensive from hypovolemia can result in severe peripheral and...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections:
- Tissue Ischemia [see Warnings and Precautions (5.1)]...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 MAO-Inhibiting Drugs
Co-administration of LEVOPHED with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Limited published data...
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Overdosage
10 OVERDOSAGE
Overdosage with LEVOPHED may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output.
In case of overdosage, discontinue...
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Description
11 DESCRIPTION
Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom.
...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Norepinephrine is a peripheral vasoconstrictor (alpha-adrenergic action) and an inotropic stimulator of the heart...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis, mutagenesis, and fertility studies have not been performed.
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
LEVOPHED (norepinephrine bitartrate) injection, USP, is a sterile, colorless solution for injection intended for intravenous use. It contains the equivalent of 1 mg of norepinephrine base...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Risk of Tissue Damage
Advise the patient, family, or caregiver to report signs of extravasation urgently...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.