epinephrine
Generic: EPINEPHRINE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
ef556382-9d19-4f0e-9dbe-fcecc772a3e2
Indications & Usage
1 INDICATIONS AND USAGE Epinephrine 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 ) • For emergency treatment of type 1 allergic reactions, including anaphylaxis in adult and pediatric patients.
( 1.2 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
1.2 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients.
( 1.1 ) • For emergency treatment of type 1 allergic reactions, including anaphylaxis in adult and pediatric patients.
( 1.2 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
1.2 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions associated with the use of epinephrine were identified in clinical use, observational trials, case reports, or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are listed below by body system: Cardiovascular : angina, arrhythmias, cerebral hemorrhage (particularly in elderly patients with cardiovascular disease), hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy.
Gastrointestinal: nausea, vomiting Metabolism and Nutrition Disorders: transient hyperglycemia, sweating Neurological : disorientation, dizziness, headache, impaired memory, panic, psychomotor agitation (particularly in patients with Parkinson’s disease), sleepiness, tingling, tremor, weakness Psychiatric : anxiety, apprehensiveness, restlessness Respiratory: respiratory difficulties Skin and subcutaneous tissue disorders: skin and soft tissue infections, necrotizing fasciitis, myonecrosis (gas gangrene) Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea/vomiting; and/or respiratory difficulties.
Arrhythmias, including fatal ventricular ectopy, and cerebral hemorrhage.
( 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 some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are listed below by body system: Cardiovascular : angina, arrhythmias, cerebral hemorrhage (particularly in elderly patients with cardiovascular disease), hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy and stress cardiomyopathy.
Gastrointestinal: nausea, vomiting Metabolism and Nutrition Disorders: transient hyperglycemia, sweating Neurological : disorientation, dizziness, headache, impaired memory, panic, psychomotor agitation (particularly in patients with Parkinson’s disease), sleepiness, tingling, tremor, weakness Psychiatric : anxiety, apprehensiveness, restlessness Respiratory: respiratory difficulties Skin and subcutaneous tissue disorders: skin and soft tissue infections, necrotizing fasciitis, myonecrosis (gas gangrene) Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea/vomiting; and/or respiratory difficulties.
Arrhythmias, including fatal ventricular ectopy, and cerebral hemorrhage.
( 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.