Drug Facts
Composition & Profile
Identifiers & Packaging
16. HOW SUPPLIED/STORAGE AND HANDLING Epinephrine Injection 1 mg/10 mL (0.1 mg/mL) is a clear and colorless solution available in glass vials. Each vial is co-packaged with an injector, which together make a single-dose ABBOJECT® Syringe. It is supplied in the following presentation. Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Store at room temperature, between 20°C to 25°C (68°F to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter. HOW SUPPLIED; PRINCIPAL DISPLAY PANEL - SYRINGE LABELING SYRINGE LABELING; PRINCIPAL DISPLAY PANEL - 51662-1531-1 CARTON LABELING AND SERIALIZED LABEL ON CARTON CARTON LABELING SERIALIZED LABELING; Principal Display Panel - 51662-1531-2 Outer Pouch Labeling Pouch Labeling Carton Labeling Syringe Labeling; Principal Display Panel - 51662-1531-3 - Carton of 50 Labeling Case Labeling 51662-1531-3, Case of 50 Serialized Label on Case Case Label RFID Label
- 16. HOW SUPPLIED/STORAGE AND HANDLING Epinephrine Injection 1 mg/10 mL (0.1 mg/mL) is a clear and colorless solution available in glass vials. Each vial is co-packaged with an injector, which together make a single-dose ABBOJECT® Syringe. It is supplied in the following presentation. Epinephrine is light sensitive. Protect from light until ready to use. Do not refrigerate. Protect from freezing. Store at room temperature, between 20°C to 25°C (68°F to 77°F). (See USP Controlled Room Temperature.) Protect from alkalis and oxidizing agents. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter. HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - SYRINGE LABELING SYRINGE LABELING
- PRINCIPAL DISPLAY PANEL - 51662-1531-1 CARTON LABELING AND SERIALIZED LABEL ON CARTON CARTON LABELING SERIALIZED LABELING
- Principal Display Panel - 51662-1531-2 Outer Pouch Labeling Pouch Labeling Carton Labeling Syringe Labeling
- Principal Display Panel - 51662-1531-3 - Carton of 50 Labeling Case Labeling 51662-1531-3, Case of 50 Serialized Label on Case Case Label RFID Label
Overview
Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is supplied as a sterile aqueous solution with a pH range of 2.3–3.5, that is clear, colorless, and nonpyrogenic. Each milliliter contains 0.1 mg epinephrine, 8.16 mg sodium chloride, 0.46 mg sodium metabisulfite, and 2.13 mg citric acid, anhydrous and 0.41 mg sodium citrate, dihydrate added as buffers. Additional citric acid and/or sodium citrate may be added for pH adjustment. The solution contains no preservatives. This sterile solution is to be administered after dilution by the intravenous route. Epinephrine is a sympathomimetic catecholamine (adrenergic agent) designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, crystalline 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. STRUCTURE
Indications & Usage
INDICATIONS & USAGE 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.
Dosage & Administration
DOSAGE & ADMINISTRATION 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 all unused drug. 2.2 Hypotension associated with Septic Shock Dilute 10 mL (1 mg) of epinephrine from the syringe in 1,000 mL of 5 percent dextrose solution or 5 percent dextrose and sodium chloride solution to produce a 1 mcg per mL dilution. The diluted solutions can be stored for up to 4 hours at room temperature or 24 hours under refrigerated conditions. Administration in saline solution alone is not recommended. If indicated, administer whole blood or plasma separately. 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 – 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.
Warnings & Precautions
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 the 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 with coronary artery disease, or cardiomyopathy [see ADVERSE REACTIONS 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 a superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is 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 within 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 Epinephrine Injection contains sodium metabisulfite which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. The presence of sodium metabisulfite 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 metabisulfite.
Contraindications
None.
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)] Allergic Reactions associated with Sulfite [see WARNINGS AND PRECAUTIONS (5.6)] The following adverse reactions have been associated with use of epinephrine. 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 (including fatal ventricular fibrillation), myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension Gastrointestinal disorders: nausea, vomiting General disorders and administrative site conditions: extravasation Metabolic: insulin resistance, hypokalemia, lactic acidosis Nervous system disorders: headache, paresthesia, tremor, stroke, central nervous system bleeding, weakness, dizziness, disorientation, impaired memory, panic, psychomotor agitation, somnolence Psychiatric disorders: excitability, anxiety, apprehensiveness, nervousness, restlessness Renal disorders: renal insufficiency Respiratory: rales Skin and subcutaneous tissue disorders: diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation.
Drug Interactions
7.1 Drugs Antagonizing Pressor Effects of Epinephrine α-blockers, such as phentolamine Vasodilators, such as nitrates Diuretics Antihypertensives Ergot alkaloids Phenothiazine antipsychotics 7.2 Drugs Potentiating Pressor Effects of Epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO) inhibitors Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone Clonidine Doxapram Oxytocin 7.3 Drugs Potentiating Arrhythmogenic Effects of Epinephrine Patients who are concomitantly receiving any of the following drugs should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS (5.5) and A DVERSE REACTIONS (6)]. β-blockers, such as propranolol Cyclopropane or halogenated hydrocarbon anesthetics, such as halothane Antihistamines Thyroid hormones Diuretics Cardiac glycosides, such as digitalis glycosides Quinidine 7.4 Drugs Potentiating Hypokalemic Effects of Epinephrine Potassium depleting diuretics Corticosteroids Theophylline
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