epinephrine
Generic: EPINEPHRINE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
60efd409-3555-4182-a68d-1cd7bc0d1bfc
Indications & Usage
1 INDICATIONS AND USAGE Epinephrine in 0.9% Sodium Chloride Injection is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine in 0.9% Sodium Chloride Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine in 0.9% Sodium Chloride Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: • Hypertension [see Warnings and Precautions (5.1) ] • Pulmonary Edema [see Warnings and Precautions (5.2) ] • Cardiac Arrhythmias and Ischemia [see Warnings and Precautions (5.3) ] • Extravasation and Tissue Necrosis with Intravenous Infusion [see Warnings and Precautions (5.4) ] • Renal Impairment [see Warnings and Precautions (5.5) ] • Allergic Reactions associated with Sulfite [see Warnings and Precautions (5.6) ] The following adverse reactions have been associated with use of epinephrine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Cardiovascular disorders : tachycardia, supraventricular tachycardia, ventricular arrhythmias (including fatal ventricular fibrillation), stress cardiomyopathy, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension Gastrointestinal disorders : nausea, vomiting Metabolic : insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence Psychiatric disorders : anxiety Skin and subcutaneous tissue disorders : diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.
Most common adverse reactions to systemically administered Epinephrine in 0.9% Sodium Chloride Injection are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; diaphoresis; nausea/vomiting; and/or respiratory difficulties.
Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Cardiovascular disorders : tachycardia, supraventricular tachycardia, ventricular arrhythmias (including fatal ventricular fibrillation), stress cardiomyopathy, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension Gastrointestinal disorders : nausea, vomiting Metabolic : insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence Psychiatric disorders : anxiety Skin and subcutaneous tissue disorders : diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.
Most common adverse reactions to systemically administered Epinephrine in 0.9% Sodium Chloride Injection are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; diaphoresis; nausea/vomiting; and/or respiratory difficulties.
Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.