Epinephrine

Q: Is Epinephrine available over the counter?

Epinephrine is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Prescription

Brand names: Epinephrine

Dosage Form

Injection

Route

INTRAVENOUS

Manufacturer

REMEDYREPACK INC.

About This Medication

11 DESCRIPTION Epinephrine, USP is a non-selective alpha and beta-adrenergic agonist designated chemically as (R) -4-(1-Hydroxy-2-(methylamino)ethyl)benzene-1,2-diol, a white, microcrystalline powder. It has the following structural formula: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is supplied as a sterile aqueous solution that is clear, colorless and nonpyrogenic. Each mL of the solution contains epinephrine (0.1 mg) as the active ingredient and the following inactive ingredients: citric acid monohydrate (3.3 mg), edetate disodium dihydrate (0.004 mg), sodium chloride (8.2 mg), sodium citrate dihydrate (1.5 mg), sodium metabisulfite, and Water for Injection. Hydrochloric acid solution is added to dissolve the active ingredient. Sodium hydroxide solution is added to adjust the pH. Nitrogen is used for blanketing protection. Solution must be diluted prior to intravenous use. structure

Active Ingredients

Ingredient	Strength
Epinephrine	-

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 ) 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.

How It Works

12.1 Mechanism of Action Epinephrine acts on both alpha (α)- and beta (β)-adrenergic receptors. The mechanism of the rise in blood pressure is 3-fold: a direct myocardial stimulation that increases the strength of ventricular contraction (positive inotropic action), an increased heart rate (positive chronotropic action), and peripheral vasoconstriction.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Hypotension associated with septic shock ( 2.2 ) : o Dilute epinephrine in dextrose solution prior to infusion. o Infuse epinephrine into a large vein. o Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure. o Wean gradually. 2.1 General Considerations Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Discard any unused portion. 2.2 Hypotension associated with Septic Shock Dilute epinephrine in 5% Dextrose Injection, USP or 5% Dextrose and Sodium Chloride solution. These dextrose containing fluids provide protection against significant loss of potency by oxidation. Administration in saline solution alone is not recommended. If indicated, administer whole blood or plasma separately. Add the entire contents of epinephrine prefilled syringe to 1000 mL of a 5% Dextrose containing solution. Each mL of this dilution contains 1 mcg of epinephrine. Whenever possible, give infusions of epinephrine into a large vein. Avoid using a catheter tie-in technique, because the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug. Avoid the veins of the leg in elderly patients or in those suffering from occlusive vascular diseases. To provide hemodynamic support in septic shock associated hypotension in adult patients, the suggested dosing infusion rate of intravenously administered epinephrine is 0.05 mcg/kg/min to 2 mcg/kg/min, and is titrated to achieve a desired mean arterial pressure (MAP). The dosage may be adjusted periodically, such as every 10 to 15 minutes, in increments of 0.05 mcg/kg/min to 0.2 mcg/kg/min, to achieve the desired blood pressure goal. After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of epinephrine every 30 minutes over a 12- to 24-hour period.

Side Effects Overview

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.

Warnings & Precautions

5 WARNINGS AND PRECAUTIONS • Monitor blood pressure frequently. (5.1) • Increases cardiac output and causes peripheral vasoconstriction. (5.2) • May induce cardiac arrhythmias and myocardial ischemia. (5.3) • Avoid extravasation into tissues, which can cause local necrosis. (5.4) • Constricts renal blood vessels which may result in oliguria or renal impairment. (5.5) • Sulfite Warning. (5.6) 5.1 Hypertension Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. 5.2 Pulmonary Edema Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. 5.3 Cardiac Arrhythmias and Ischemia Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease or cardiomyopathy [see Adverse Reactions (6) and Drug Interactions (7.3)] . 5.4 Extravasation and Tissue Necrosis with Intravenous Infusion Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Epinephrine Injection is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is a potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated with 12 hours. 5.5 Renal Impairment Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. 5.6 Allergic Reactions Associated with Sulfite Contains sodium bisulfite, which may cause mild to severe allergic reactions including anaphylaxis orasthmatic episodes, particularly in patients with a history of allergies. The presence of sodium bisulfite in this product should not preclude its use for the treatment of hypotension associated with septic shock, even if the patient is sulfite-sensitive, as the alternatives to using epinephrine in a life-threatening situation may not be satisfactory. In susceptible patients, consider using a formulation of epinephrine or another vasoconstrictor that does not contain sodium bisulfite.

Contraindications

4 CONTRAINDICATIONS None. None.

Pharmacokinetics

12.3 Pharmacokinetics Following intravenous injection, epinephrine is rapidly cleared from the plasma with an effective half-life of < 5 min. A pharmacokinetic steady state following continuous intravenous infusion is achieved within 10-15 min. In patients with septic shock, epinephrine displays dose-proportional pharmacokinetics in the infusion dose range of 0.03 to 1.7 mcg/kg/min. Epinephrine is extensively metabolized with only a small amount excreted unchanged. Epinephrine is rapidly degraded to vanillylmandelic acid, an inactive metabolite, by monoamine oxidase and catechol-O-methyltransferase that are abundantly expressed in the liver, kidneys and other extraneuronal tissues. The tissues with the highest contribution to removal of circulating exogenous epinephrine are the liver (32%), kidneys (25%), skeletal muscle (20%), and mesenteric organs (12%). Specific Populations Elderly In a pharmacokinetic study of 45-minute epinephrine infusions given to healthy men aged 20 to 25 years and healthy men aged 60 to 65 years, the mean plasma metabolic clearance rate of epinephrine at steady state was greater among the older men (144.8 versus 78 mL/kg/min for a 14.3 ng/kg/min infusion). Body Weight Body weight has been found to influence epinephrine pharmacokinetics. Higher body weight was associated with a higher plasma epinephrine clearance and a lower concentration plateau.

Frequently Asked Questions

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.

2 DOSAGE AND ADMINISTRATION • Hypotension associated with septic shock ( 2.2 ) : o Dilute epinephrine in dextrose solution prior to infusion. o Infuse epinephrine into a large vein. o Titrate 0.05 mcg/kg/min to 2 mcg/kg/min to achieve desired blood pressure. o Wean gradually. 2.1 General Considerations Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Discard …

5 WARNINGS AND PRECAUTIONS • Monitor blood pressure frequently. (5.1) • Increases cardiac output and causes peripheral vasoconstriction. (5.2) • May induce cardiac arrhythmias and myocardial ischemia. (5.3) • Avoid extravasation into tissues, which can cause local necrosis. (5.4) • Constricts renal blood vessels which may result in oliguria or renal impairment. (5.5) • Sulfite Warning. (5.6) 5.1 Hypertension Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. …

4 CONTRAINDICATIONS None. None.

Epinephrine is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Epinephrine drug label (National Library of Medicine)
• openFDA — Epinephrine label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 727373 (NLM Normalized Drug Names)
• NDC Directory — Epinephrine (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS