Adrenalin (epinephrine in sodium chloride)
Generic: EPINEPHRINE IN SODIUM CHLORIDE
Basic Information
Manufacturer
Par Health USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
61b0e2a2-71ed-43d6-b1a7-36d2dae651b5
Indications & Usage
1.
INDICATIONS AND USAGE Adrenalin ® 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 Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
INDICATIONS AND USAGE Adrenalin ® 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 Adrenalin 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 )] The following adverse reactions associated with the infusion of epinephrine were identified in the literature.
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, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, stroke, central nervous system bleeding Psychiatric disorders : Excitability Renal disorders : Renal insufficiency Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation 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 Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 )] The following adverse reactions associated with the infusion of epinephrine were identified in the literature.
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, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Metabolic : hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis Nervous system disorders : Headache, nervousness, paresthesia, tremor, stroke, central nervous system bleeding Psychiatric disorders : Excitability Renal disorders : Renal insufficiency Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation 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 Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .