Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Norepinephrine Bitartrate Injection, USP, contains the equivalent of 4 mg base of norepinephrine per each 4 mL ampule (1 mg/mL), and is available as follows: AIN00610 NDC 36000-162-10 Ampules of 4 mL in shelf carton of 10 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.] Store in original carton until time of administration to protect from light. Discard unused portion.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 4mg/mL AIN00610 NDC: 36000-162-01 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL (1 mg per mL) Rx Only CONTAINS NO SULFITES - PRESERVATIVE FREE Each mL contains: norepinephrine bitartrate equal to 1mg norepinephrine base. FOR IV INFUSION ONLY - DILUTE BEFORE USE. PROTECT FROM LIGHT. Directions: See Insert. BAXTER Deerfield, IL 60015 USA 68797 02 2018-10-31 STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each Norepinephrine Bitartrate Injection, USP Rx only 4 mg/4 mL (1 mg per mL) CONTAINS NO SULFITES – PRESERVATIVE FREE Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully. FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION. Usual Dosage and Dilution Information - See package insert. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents. Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity. The air in the ampules has been displaced by nitrogen gas. These ampules are Easy Break Ampules. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in carton until time of use. PROTECT FROM LIGHT. Manufactured by: Sintetica S.A. Switzerland Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA 66797 02 2018-10-31 STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each Norepinephrine Bitartrate Injection, USP Rx only 4 mg/4 mL (1 mg per mL) CONTAINS NO SULFITES – PRESERVATIVE FREE Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully. FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION. Usual Dosage and Dilution Information - See package insert. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents. Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity. The air in the ampules has been displaced by nitrogen gas. These ampules are Easy Break Ampules. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in carton until time of use. PROTECT FROM LIGHT. Manufactured by: Sintetica S.A. Switzerland Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA 420100139-01 2023-04-14 image-02 image-03 image-04
- 16 HOW SUPPLIED/STORAGE AND HANDLING Norepinephrine Bitartrate Injection, USP, contains the equivalent of 4 mg base of norepinephrine per each 4 mL ampule (1 mg/mL), and is available as follows: AIN00610 NDC 36000-162-10 Ampules of 4 mL in shelf carton of 10 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.] Store in original carton until time of administration to protect from light. Discard unused portion.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 4mg/mL AIN00610 NDC: 36000-162-01 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL (1 mg per mL) Rx Only CONTAINS NO SULFITES - PRESERVATIVE FREE Each mL contains: norepinephrine bitartrate equal to 1mg norepinephrine base. FOR IV INFUSION ONLY - DILUTE BEFORE USE. PROTECT FROM LIGHT. Directions: See Insert. BAXTER Deerfield, IL 60015 USA 68797 02 2018-10-31 STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each Norepinephrine Bitartrate Injection, USP Rx only 4 mg/4 mL (1 mg per mL) CONTAINS NO SULFITES – PRESERVATIVE FREE Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully. FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION. Usual Dosage and Dilution Information - See package insert. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents. Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity. The air in the ampules has been displaced by nitrogen gas. These ampules are Easy Break Ampules. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in carton until time of use. PROTECT FROM LIGHT. Manufactured by: Sintetica S.A. Switzerland Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA 66797 02 2018-10-31 STERILE INJECTION AIN00610 NDC : 36000-162-10 10 Ampules 4 mL Each Norepinephrine Bitartrate Injection, USP Rx only 4 mg/4 mL (1 mg per mL) CONTAINS NO SULFITES – PRESERVATIVE FREE Warning: This is a potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully. FOR INTRAVENOUS INFUSION ONLY. DILUTE BEFORE USE. DISCARD UNUSED PORTION. Usual Dosage and Dilution Information - See package insert. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Avoid contact with iron salts, alkalis, or oxidizing agents. Each mL contains: norepinephrine bitartrate, equivalent to 1 mg norepinephrine base, sodium chloride for isotonicity. The air in the ampules has been displaced by nitrogen gas. These ampules are Easy Break Ampules. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Retain in carton until time of use. PROTECT FROM LIGHT. Manufactured by: Sintetica S.A. Switzerland Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA 420100139-01 2023-04-14 image-02 image-03 image-04
Overview
Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine bitartrate, USP is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula: Norepinephrine bitartrate injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 2 mg of norepinephrine bitartrate), sodium chloride for isotonicity. It has a pH of 3 to 4.5. The air in the ampules has been displaced by nitrogen gas. structure-1
Indications & Usage
Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )
Dosage & Administration
• Initial dose of 0.25 mL to 0.375 mL (from 8 mcg to 12 mcg of base) per minute, adjust the rate of flow to establish and maintain a low to normal blood pressure (usually 80 mm Hg to 100 mm Hg systolic) sufficient to maintain the circulation of vital organs. ( 2.2 ) • The average maintenance dose ranges from 0.0625 mL to 0.125 mL per minute (from 2 mcg to 4 mcg of base). ( 2.2 ) 2.1 Important Dosage and Administration Instructions Correct Hypovolemia Address hypovolemia before initiation of norepinephrine bitartrate injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions ( 5.1 )] . Administration Dilute norepinephrine bitartrate injection prior to use [see Dosage and Administration ( 2.3 )] . Infuse norepinephrine bitartrate injection into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions ( 5.1 )]. Avoid using a catheter-tie-in technique . Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. 2.2 Dosage After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion. Typical maintenance intravenous dosage is 2 to 4 mcg per minute. 2.3 Preparation of Diluted Solution Visually inspect norepinephrine bitartrate injection for particulate matter and discoloration prior to administration (the solution is colorless) . Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Add the content of one norepinephrine bitartrate injection ampule (4 mg in 4 mL) to 1,000 mL of 5% Dextrose Injection, USP or Sodium Chloride Injection solutions that contain 5% dextrose to produce a 4 mcg per mL dilution. Dextrose reduces loss of potency due to oxidation. Administration in saline solution alone is not recommended. Use higher concentration solutions in patients requiring fluid restriction. Prior to use, store the diluted norepinephrine bitartrate injection solution for up to 24 hours at room temperature [20°C to 25°C (68°F to 77°F)] and protect from light. 2.4 Drug Incompatibilities Avoid contact with iron salts, alkalis, or oxidizing agents. Whole blood or plasma, if indicated to increase blood volume, should be administered separately.
Warnings & Precautions
• Tissue Ischemia : Avoid extravasation of norepinephrine bitartrate injection into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Infuse norepinephrine bitartrate injection into a large vein. To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of an adrenergic blocking agent. ( 5.1 ) • Hypotension After Abrupt Discontinuation : Sudden cessation of the infusion rate may result in marked hypotension. Reduce the norepinephrine bitartrate injection infusion rate gradually. ( 5.2 ) • Cardiac Arrhythmias: Norepinephrine bitartrate injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 ) 5.1 Tissue Ischemia Administration of norepinephrine bitartrate injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating norepinephrine bitartrate injection [see Dosage and Administration ( 2.1 )]. Avoid norepinephrine bitartrate injection in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction. Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of norepinephrine bitartrate injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation [see Dosage and Administration ( 2.1 )]. Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. 5.2 Hypotension after Abrupt Discontinuation Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the norepinephrine bitartrate injection infusion rate while expanding blood volume with intravenous fluids. 5.3 Cardiac Arrhythmias Norepinephrine bitartrate injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.
Contraindications
None. None. ( 4 )
Adverse Reactions
The following adverse reactions are described in greater detail in other sections: • Tissue Ischemia [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Cardiac Arrhythmias [see Warnings and Precautions ( 5.3 )] The most common adverse reactions are hypertension and bradycardia. The following adverse reactions can occur: Nervous system disorders: Anxiety, headache Respiratory disorders: Respiratory difficulty, pulmonary edema Most common adverse reactions are ischemic injury, bradycardia, anxiety, transient headache, respiratory difficulty, and extravasation necrosis at injection site. ( 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
• Monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may result in hypertension. ( 7.1 ) • Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ( 7.4 ) 7.1 MAO-Inhibiting Drugs Co-administration of norepinephrine bitartrate injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) can cause severe, prolonged hypertension. If administration of norepinephrine bitartrate injection cannot be avoided in patients who recently have received any of these drugs and in whom, after discontinuation, MAO activity has not yet sufficiently recovered, monitor for hypertension. 7.2 Tricyclic Antidepressants Co-administration of norepinephrine bitartrate injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of norepinephrine bitartrate injection cannot be avoided in these patients, monitor for hypertension. 7.3 Antidiabetics Norepinephrine bitartrate injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs. 7.4 Halogenated Anesthetics Concomitant use of norepinephrine bitartrate injection with halogenated anesthetics (e.g., cyclopropane, desflurane, enflurane, isoflurane, and sevoflurane) may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics.
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