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EPINEPHRINE ABBOJECT NDC 0409-4933-01 (Epinephrine injection, USP ABBOJECT)
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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.
EPINEPHRINE ABBOJECT NDC 0409-4933-01 Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Hypotension associated with Septic Shock
Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
Inspect visually for particulate matter and discoloration prior to administration, whenever solution and...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection solution: 10 mL clear glass vial containing 1 mg/10 mL (0.1 mg/mL) epinephrine in a sterile, nonpyrogenic, clear and colorless solution. Each vial is co-packaged with an injector, which...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypertension
Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in labeling:
- Hypertension [see Warnings and Precautions (5.1)]
- ...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs Antagonizing Pressor Effects of Epinephrine
- α-blockers, such as phentolamine
- Vasodilators, such as nitrates
- ...
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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 of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema...
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Description
11 DESCRIPTION
Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is supplied as a sterile aqueous solution with a pH range of 2.3–3.5, that is clear, colorless, and nonpyrogenic. Each milliliter contains 0.1 mg epinephrine,...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Epinephrine acts on both alpha (α)- and beta (β)-adrenergic receptors. The mechanism of the rise in blood pressure...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to evaluate the carcinogenic potential of epinephrine have not...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Hypotension associated with Septic Shock
Fourteen clinical studies from the literature documented that epinephrine increases the mean...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Epinephrine Injection 1 mg/10 mL (0.1 mg/mL) is a clear and colorless solution available in glass vials. Each vial is co-packaged with an injector, which together make a single-dose...
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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.