EPINEPHRINE
Generic: EPINEPHRINE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
4f83895f-638c-4515-af03-7c41ae60a42e
Indications & Usage
1 INDICATIONS AND USAGE Epinephrine is a non-selective alpha and beta adrenergic agonist indicated: • For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
( 1.1 ) • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
( 1.2 ) 1.1 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients.
1.2 Hypotension associated with Septic Shock Epinephrine Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
( 1.1 ) • To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
( 1.2 ) 1.1 Anaphylaxis Epinephrine Injection is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients.
1.2 Hypotension associated with Septic Shock Epinephrine 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 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; peripheral coldness; 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 Fresenius Kabi USA, LLC at 1-800-551-7176 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; peripheral coldness; 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch