Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Norepinephrine Bitartrate in Dextrose Injection for intravenous infusion is a colorless to slightly yellow solution available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL, 8 mg/250 mL, and 16 mg/250 mL contains the equivalent of 4 mg, 8 mg, and 16 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following: Product Description NDC Number Twenty containers of 4 mg/250 mL NDC 0338-0112-20 Twenty containers of 8 mg/250 mL NDC 0338-0108-20 Twenty containers of 16 mg/250 mL NDC 0338-0116-20 Store at room temperature [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]. Protect from light. Once the overwrap is removed, the bag can be stored at room temperature for up to 30 days.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label EZPE7748 NDC 0338-0112-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 4 mg / 250 mL (16 mg / mL) For Intravenous Infusion Only Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 1.6 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-133 VIAFLO container Symbol 07 0 Symbol Do not use this port Barcode (01)00303380112203 LOT EXP Container Label EZPE7788 NDC 0338-0108-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 8 mg / 250 mL (32 mcg / mL) For Intravenous Infusion Only Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 3.2 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland VIAFLO container Symbol Do not use this port Symbol 07 0 CB-35-05-134 Symbol 1 Barcode (01)00303380108206 LOT EXP Container Label EZPE7758 NDC 0338-0116-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 16 mg / 250 mL (64 mcg / mL) For Intravenous Infusion Only Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 6.4 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland VIAFLO container Symbol Do not use this port Symbol 07 0 CB-35-05-144 Symbol 1 Barcode (01)00303380116201 LOT EXP Representative Norepinephrene Container Label 0338-0112-20 Representative Norepinephrene Container Label 0338-0108-20 Representative Norepinephrene Container Label 0338-0116-20
- 16 HOW SUPPLIED/STORAGE AND HANDLING Norepinephrine Bitartrate in Dextrose Injection for intravenous infusion is a colorless to slightly yellow solution available in single-dose, ready-to-use containers in an amber/foil overwrap. Each 250 mL of Norepinephrine Bitartrate in Dextrose Injection , 4 mg/250 mL, 8 mg/250 mL, and 16 mg/250 mL contains the equivalent of 4 mg, 8 mg, and 16 mg of norepinephrine, respectively (provided as norepinephrine bitartrate monohydrate). Norepinephrine Bitartrate in Dextrose Injection is available in the following: Product Description NDC Number Twenty containers of 4 mg/250 mL NDC 0338-0112-20 Twenty containers of 8 mg/250 mL NDC 0338-0108-20 Twenty containers of 16 mg/250 mL NDC 0338-0116-20 Store at room temperature [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]. Protect from light. Once the overwrap is removed, the bag can be stored at room temperature for up to 30 days.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label EZPE7748 NDC 0338-0112-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 4 mg / 250 mL (16 mg / mL) For Intravenous Infusion Only Each 100mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 1.6 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland CB-35-05-133 VIAFLO container Symbol 07 0 Symbol Do not use this port Barcode (01)00303380112203 LOT EXP Container Label EZPE7788 NDC 0338-0108-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 8 mg / 250 mL (32 mcg / mL) For Intravenous Infusion Only Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 3.2 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland VIAFLO container Symbol Do not use this port Symbol 07 0 CB-35-05-134 Symbol 1 Barcode (01)00303380108206 LOT EXP Container Label EZPE7758 NDC 0338-0116-20 250 mL Norepinephrine Bitartrate in 5% Dextrose Injection 16 mg / 250 mL (64 mcg / mL) For Intravenous Infusion Only Each 100 mL of sterile, nonpyrogenic solution contains: Norepinephrine Bitartrate Monohydrate USP equivalent to 6.4 mg norepinephrine and 5 g Dextrose Monohydrate in Water for Injection, USP. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Single Dose Only – Discard unused portion. For Intravenous Use. Recommended 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.] Protect from light. Keep in overwrap until ready to use. Once removed from overwrap , bag can be stored at room temperature and should be used within 30 days . VIAFLO container is not made with natural rubber latex, DEHP, or PVC. Rx Only Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Ireland VIAFLO container Symbol Do not use this port Symbol 07 0 CB-35-05-144 Symbol 1 Barcode (01)00303380116201 LOT EXP Representative Norepinephrene Container Label 0338-0112-20 Representative Norepinephrene Container Label 0338-0108-20 Representative Norepinephrene Container Label 0338-0116-20
Overview
Norepinephrine Bitartrate in Dextrose Injection contains norepinephrine, a sympathomimetic amine. Norepinephrine is sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, norepinephrine bitartrate monohydrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate and has the following structural formula: Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Norepinephrine Bitartrate in Dextrose Injection is supplied as a sterile aqueous solution administered by intravenous infusion. Each mL contains the equivalent of 16, 32, or 64 micrograms of norepinephrine base supplied as 31.90, 63.80, and 127.60 micrograms per mL of norepinephrine bitartrate monohydrate. It contains dextrose monohydrate (50 mg/mL) and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. It has a target pH of 3.7. The air in the containers has been displaced by nitrogen gas. Structural Formula
Indications & Usage
Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate in Dextrose Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )
Dosage & Administration
• No further dilution prior to infusion is required. ( 2.1 ) • Initiate at 8 to 12 mcg/min, and adjust the rate to maintain blood pressure sufficient to maintain the circulation of vital organs. ( 2.2 ) • The average maintenance dose ranges from 2 to 4 mcg/min. ( 2.2 ) 2.1 Important Dosage and Administration Instructions Correct Hypovolemia Address hypovolemia before initiation of Norepinephrine Bitartrate in Dextrose Injection therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1)] . Administration Norepinephrine Bitartrate in Dextrose Injection is a ready to administer product that requires no further dilution prior to infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Infuse Norepinephrine Bitartrate in Dextrose 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. The choice of appropriate concentration of Norepinephrine Bitartrate in Dextrose Injection depends on clinical fluid volume requirements. Use higher concentration solutions in patients requiring fluid restriction. 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 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 : Infuse Norepinephrine Bitartrate in Dextrose Injection into a large vein. To prevent sloughing and necrosis in areas in with extravasation, infiltrate the area with an adrenergic blocking agent in saline. ( 5.1 ) • Hypotension After Abrupt Discontinuation: Gradually taper a norepinephrine infusion to prevent hypotension. ( 5.2 ) • Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 ) 5.1 Tissue Ischemia Administration of Norepinephrine Bitartrate in Dextrose 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 in Dextrose Injection [see Dosage and Administration (2.1) ]. Avoid Norepinephrine Bitartrate in Dextrose 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 in Dextrose 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 in Dextrose Injection infusion rate while expanding blood volume with intravenous fluids. 5.3 Cardiac Arrhythmias Norepinephrine Bitartrate in Dextrose 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 serious 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 General disorders and administration site conditions : Extravasation, injection site necrosis [see Warnings and Precautions (5.1)] . Serious adverse reactions are described in greater detail in other sections [see Warnings and Precautions ( 5.1 , 5.2 , & 5.3 )]. Most common adverse reactions are hypertension, bradycardia, ischemic injury, anxiety, headache, respiratory difficulty, pulmonary edema, and extravasation necrosis at injection site. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• Monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants of the triptyline or imipramine types may result in hypertension. ( 7.1 , 7.2 ) • Antidiabetics: Norepinephrine can decrease insulin sensitivity and raise blood glucose ( 7.3 ) • Cyclopropane and halothane anesthetics increase cardiac autonomic irritability. ( 7.4 ) 7.1 MAO-Inhibiting Drugs Co-administration of Norepinephrine Bitartrate in Dextrose 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 in Dextrose 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 in Dextrose Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine Bitartrate in Dextrose Injection cannot be avoided in these patients, monitor for hypertension. 7.3 Antidiabetics Norepinephrine Bitartrate in Dextrose 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 in Dextrose 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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