Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Epinephrine in 0.9% Sodium Chloride Injection is a clear and colorless solution filled in a single dose 250 mL VIAFLO container. Epinephrine in 0.9% Sodium Chloride Injection is supplied as a carton of 20 bags in a 16 mg/250 mL (64 mcg/mL) strength, NDC 0338-0024-20. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. Protect from alkalis and oxidizing agents. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries. CB-30-03-117; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Epinephrine in 0.9% Sodium Chloride Injection, 16 mg/250 mL NDC 0338- 0024 -20 Rx Only Epinephrine in 0.9% Sodium Chloride Injection 16 mg/250 mL (64 mcg/mL) 250 mL Warning: check concentration and infusion rate For Intravenous Infusion Only Ready to Use. Single-Dose Only - Discard unused portion. Not for Ophthalmic Use. Each mL contains Epinephrine Bitartrate 116.4 mcg which is equivalent to Epinephrine base 64 mcg , Edetate Disodium 0.032 mg , Sodium Chloride 9 mg , Sodium Metabisulfite 0.05 mg , Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide to adjust pH range of 3.4 to 4.5. Dosage: See Prescribing Information. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. Store in overpouch until time of use. After removing the overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland EZPE8835 CB-35-05-612 DO NOT USE THIS PORT LOT EXP TO OPEN: TEAR AT NOTCH NDC 0338- 0024 -20 Rx Only Epinephrine in 0.9% Sodium Chloride Injection 16 mg/250 mL (64 mcg/mL) 250 mL Warning: check concentration and infusion rate For Intravenous Infusion Only Ready to Use. Single-Dose Only - Discard unused portion. Not for Ophthalmic Use. Each mL contains Epinephrine Bitartrate 116.4 mcg which is equivalent to Epinephrine base 64 mcg , Edetate Disodium 0.032 mg , Sodium Chloride 9 mg , Sodium Metabisulfite 0.05 mg , Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide to adjust pH range of 3.4 to 4.5. Dosage: See Prescribing Information. TO OPEN: TEAR AT NOTCH. Do not use if overpouch has been previously opened or damaged. Use unit promptly once overpouch is removed. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. The container closure is not made with natural rubber latex. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland EZPE8835 CB-10-01-260 (See Solution Container for Lot and Exp) bag-label-16mg-250ml-2 overpouch-16mg-250ml-3
- 16 HOW SUPPLIED/STORAGE AND HANDLING Epinephrine in 0.9% Sodium Chloride Injection is a clear and colorless solution filled in a single dose 250 mL VIAFLO container. Epinephrine in 0.9% Sodium Chloride Injection is supplied as a carton of 20 bags in a 16 mg/250 mL (64 mcg/mL) strength, NDC 0338-0024-20. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. Protect from alkalis and oxidizing agents. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries. CB-30-03-117
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Epinephrine in 0.9% Sodium Chloride Injection, 16 mg/250 mL NDC 0338- 0024 -20 Rx Only Epinephrine in 0.9% Sodium Chloride Injection 16 mg/250 mL (64 mcg/mL) 250 mL Warning: check concentration and infusion rate For Intravenous Infusion Only Ready to Use. Single-Dose Only - Discard unused portion. Not for Ophthalmic Use. Each mL contains Epinephrine Bitartrate 116.4 mcg which is equivalent to Epinephrine base 64 mcg , Edetate Disodium 0.032 mg , Sodium Chloride 9 mg , Sodium Metabisulfite 0.05 mg , Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide to adjust pH range of 3.4 to 4.5. Dosage: See Prescribing Information. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. Store in overpouch until time of use. After removing the overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland EZPE8835 CB-35-05-612 DO NOT USE THIS PORT LOT EXP TO OPEN: TEAR AT NOTCH NDC 0338- 0024 -20 Rx Only Epinephrine in 0.9% Sodium Chloride Injection 16 mg/250 mL (64 mcg/mL) 250 mL Warning: check concentration and infusion rate For Intravenous Infusion Only Ready to Use. Single-Dose Only - Discard unused portion. Not for Ophthalmic Use. Each mL contains Epinephrine Bitartrate 116.4 mcg which is equivalent to Epinephrine base 64 mcg , Edetate Disodium 0.032 mg , Sodium Chloride 9 mg , Sodium Metabisulfite 0.05 mg , Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide to adjust pH range of 3.4 to 4.5. Dosage: See Prescribing Information. TO OPEN: TEAR AT NOTCH. Do not use if overpouch has been previously opened or damaged. Use unit promptly once overpouch is removed. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light until ready to use. Store in overpouch until time of use. The container closure is not made with natural rubber latex. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland EZPE8835 CB-10-01-260 (See Solution Container for Lot and Exp) bag-label-16mg-250ml-2 overpouch-16mg-250ml-3
Overview
Epinephrine in 0.9% Sodium Chloride Injection is a clear, colorless sterile solution containing 16 mg (64 mcg epinephrine base per mL which is equivalent to 116.4 mcg epinephrine bitartrate) epinephrine, USP in 250 mL VIAFLO bag. In 250 ml VIAFLO bag, each 1 mL of Epinephrine in 0.9% Sodium Chloride Injection solution contains 0.032 mg edetate disodium, 9 mg sodium chloride, 0.05 mg sodium metabisulfite, water for injection. Hydrochloric acid and/or sodium hydroxide to adjust pH range of 3.4 to 4.5. This sterile solution is to be administered by the intravenous route. Epinephrine Bitartrate, USP is a sympathomimetic catecholamine (adrenergic agent) designated chemically as 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R) -,[ R -( R *, R *)]-2,3-dihydroxybutanedioate (1:1) (salt), a white or greyish-white or light brownish-grey, odourless, crystalline powder. Slowly darkens on exposure to air and light. It has the following structural formula: The molecular weight of epinephrine bitartrate is 333.3 and molecular formula is C 9 H 13 NO 3 • C 4 H 6 O 6 . Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. VIAFLO container is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. image-01-structural-formula-epinephrine
Indications & Usage
Epinephrine in 0.9% Sodium Chloride Injection 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 in 0.9% Sodium Chloride Injection is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Dosage & Administration
Hypotension associated with septic shock : • Infuse Epinephrine in 0.9% Sodium Chloride Injection into a large vein. ( 2.2 ) • Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated to achieve desired mean arterial pressure. ( 2.2 ) • Wean gradually. ( 2.2 ) 2.1 General Considerations Epinephrine in 0.9% Sodium Chloride Injection is a ready to administer product that requires no further dilution prior to infusion. 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 Whenever possible, give infusions of Epinephrine in 0.9% Sodium Chloride Injection 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 in 0.9% Sodium Chloride Injection 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. The ideal body weight (IBW) should be used as the weight parameter for dosing epinephrine in adult patients with septic shock associated hypotension. After hemodynamic stabilization, wean incrementally over time, such as by decreasing doses of Epinephrine in 0.9% Sodium Chloride Injection every 30 minutes over a 12 to 24 hour period.
Warnings & Precautions
• Monitor patient for acute severe hypertension. ( 5.1 ) • Potential for pulmonary edema, which may be fatal. ( 5.2 ) • May induce potentially serious cardiac arrhythmias and myocardial ischemia, particularly in patients with underlying heart disease. ( 5.3 ) • Avoid extravasation into tissues, which can cause local necrosis. ( 5.4 ) • Potential for oliguria or renal impairment. ( 5.5 ) • Presence of sulfite in this product should not deter use for hypotension associated with septic shock ( 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 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 in 0.9% Sodium Chloride 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 in 0.9% Sodium Chloride 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. None. ( 4 )
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), stress cardiomyopathy, myocardial ischemia, myocardial infarction, limb ischemia, pulmonary edema, hypertension Gastrointestinal disorders : nausea, vomiting 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 : anxiety Skin and subcutaneous tissue disorders : diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation. Most common adverse reactions to systemically administered Epinephrine in 0.9% Sodium Chloride Injection are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; diaphoresis; 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 Baxter Healthcare Corporation at 1-877-725-2747, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• Drugs that counter the pressor effects of Epinephrine in 0.9% Sodium Chloride Injection include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. ( 7.1 ) • Drugs that potentiate the effects of Epinephrine in 0.9% Sodium Chloride Injection include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. ( 7.2 ) • Drugs that increase the arrhythmogenic potential of Epinephrine in 0.9% Sodium Chloride Injection include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias. ( 7.3 ) • Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of Epinephrine in 0.9% Sodium Chloride Injection. ( 7.4 ) 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 Adverse 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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