FDA

Norepinephrine Bitartrate in 5% Dextrose

Approved 15 Jan 2021IntravenousSolution

The FDA lists this product in 6 strengths and forms.

Indications

Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )

Contraindications

None.

None. ( 4 )

Warnings and precautions

Tissue Ischemia : Infuse Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride 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 or Norepinephrine Bitartrate in Sodium Chloride Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 )
Allergic Reactions with Sulfite : Norepinephrine Bitartrate in Sodium Chloride Injection contains sodium metabisulfite: Sulfite may cause allergic-type reactions. ( 5.4 )

5.1 Tissue Ischemia Administration of Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride 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 or Norepinephrine Bitartrate in Sodium Chloride Injection [see Dosage and Administration (2.1) ].

Indications

Warnings and precautions

Tissue Ischemia : Infuse Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride 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 or Norepinephrine Bitartrate in Sodium Chloride Injection may cause arrhythmias. Monitor cardiac function in patients with underlying heart disease. ( 5.3 )
Allergic Reactions with Sulfite : Norepinephrine Bitartrate in Sodium Chloride Injection contains sodium metabisulfite: Sulfite may cause allergic-type reactions. ( 5.4 )

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 or Norepinephrine Bitartrate in Sodium Chloride 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 or Norepinephrine Bitartrate in Sodium Chloride 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 or Norepinephrine Bitartrate in Sodium Chloride Injection with tricyclic antidepressants (including amitriptyline, nortriptyline, protriptyline, clomipramine, desipramine, imipramine) can cause severe, prolonged hypertension. If administration of Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride Injection cannot be avoided in these patients, monitor for hypertension.

7.3Antidiabetics Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride

Injection can decrease insulin sensitivity and raise blood glucose. Monitor glucose and consider dosage adjustment of antidiabetic drugs.

7.4Halogenated Anesthetics

Concomitant use of Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride 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.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated.

(see Clinical Considerations). In animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. Clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see Data). Increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m 3 basis for four days during organogenesis (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated.

Delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. Data Animal Data A study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2 mcg/min -4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow.

Decreases in fetal oxygenation, urine and lung liquid flow were also observed. Norepinephrine administration to pregnant rats on Gestation Day 16 or 17 resulted in cataract production in rat fetuses. In hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m 2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from Gestation Day 7-10).

Norepinephrine Bitartrate in 5% Dextrose

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Norepinephrine Bitartrate in 5% Dextrose

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.2Hypotension after Abrupt Discontinuation

5.3Cardiac Arrhythmias Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride

5.4Allergic Reactions Associated with Sulfite

Interactions

7.3Antidiabetics Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride

7.4Halogenated Anesthetics

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance