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 ) 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 pressure in adult patients with hypotension associated with septic shock.

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)] • Extravassation 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 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.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc.

at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.