Norepinephrine is an active pharmaceutical ingredient in the Adrenergic and Dopaminergic Agents group (C01CA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised June 16, 2025[1]
Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion is indicated in adults for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.
How to take
GB
CACanada· Health Canada
7 products
Uses
CAOfficial regulatory label· revised January 6, 2026[2]
Norepinephrine Bitartrate in 5% Dextrose Injection is recommended for the restoration and maintenance of blood pressure in all acute hypotensive or shock states which may result from surgery, trauma, hemorrhage, myocardial infarction, pheochromocytomectomy, sympathectomy, spinal anesthesia, septicemia, drug reactions, poliomyelitis and blood transfusion reactions.
). It may also be useful as an adjunct in the treatment of cardiac arrest and profound hypotension. CONTRAINDICATIONS Norepinephrine Bitartrate in 5% Dextrose Injection should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed.
If Norepinephrine Bitartrate in 5% Dextrose Injection is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis.
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised June 17, 2025[3]
1 INDICATIONS AND 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 )
How to take
Drug interactions
Known interactions involving Norepinephrine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL187190028 · revised June 16, 2025
[2]Health Canada (DPD) · 02501430 · revised January 6, 2026
[3]FDA DailyMed · 0ea48ab6-e166-df… · revised June 17, 2025 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
6, the final concentration of the infusion solution is 40 mg/litre noradrenaline base, which is equivalent to 80 mg/litre noradrenaline tartrate. Some clinicians may prefer to dilute to other concentrations. If dilutions other than 40 mg/l are used, check the infusion rate calculation carefully before starting treatment.
32 ml/min). 6 mg/hour noradrenaline tartrate). 4 mg/hour noradrenaline tartrate). 1 μg/kg/min of noradrenaline base according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension.
The aim should be to establish a low normal systolic blood pressure (100 - 120 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 65 - 80 mm Hg – depending on the patient’s condition). 4 135 Duration of treatment and monitoring The noradrenaline infusion should be continued until adequate blood pressure and tissue perfusion are maintained without therapy.
The patient should be monitored carefully for the duration of noradrenaline therapy. Noradrenaline should only be administered by healthcare professionals who are familiar with its use and have appropriate facilities to adequately monitor the patient.
Withdrawal of therapy The noradrenaline infusion should be reduced gradually, avoiding abrupt withdrawal which can result in acute hypotension. Hepatic/renal impairment There is no experience in treatment of hepatically or renally impaired patients.
4). Paediatric population The safety and efficacy of noradrenaline in children and adolescents aged less than 18 years old has not yet been established. No data are available. Method of administration Route of administration For intravenous use only after dilution.
6. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter. Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion should be administered as a diluted solution and it should be administered via a central venous catheter.
4 “Extravasation”). A catheter tie-in technique should be avoided if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised June 16, 2025[1]
Table 2 lists adverse reactions that have been experienced following treatment with noradrenaline. This data has largely been collected from spontaneous reporting, and due to the problems in calculating reporting frequencies from spontaneous reporting, the frequency of the listed adverse reactions is ‘not known’ (cannot be estimated from the available data).
The adverse reactions are reported in decreasing order of frequency within each system order class (SOC). Table 2 Adverse reactions reported with noradrenaline through spontaneous reporting System Organ Class Undesirable effect Psychiatric disorders Anxiety, insomnia, confusion, weakness, psychotic state Nervous system disorders Transient headache, tremor Eyes disorders Acute glaucoma (very frequent in patients anatomically predisposed with a closing of the iridocorneal angle).
4), peripheral ischaemia2 including gangrene of the extremities, plasma volume depletion with prolonged use Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory insufficiency or difficulty Gastrointestinal disorders Nausea, vomiting Skin and subcutaneous tissue disorders Paleness, scarification of the skin, bluish skin colour, hot flushes or skin redness, skin rash, hives or itching Renal and urinary tract disorders Retention of urine General disorders and administration site conditions Extravasation, necrosis at injection site 1 Bradycardia, probably as a reflex result of a rise in blood pressure 2 Ischaemia, due to potent vasoconstrictor action and tissue hypoxia Hypertension may occur, which may be associated with bradycardia as well as headache and peripheral ischemia, including gangrene of the extremities.
4): - severe peripheral and visceral vasoconstriction - decrease in renal blood flow - decrease in urine production - hypoxia - increase in lactate serum levels. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised June 16, 2025[1]
Do not use undiluted. 3). 8). If noradrenaline is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite “normal” blood pressure, tissue hypoxia and lactic acidosis.
g. if given simultaneously, use Y-tubing and individual containers). Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy.
, decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischaemic injury; gangrene of extremities has been rarely reported. When infusing noradrenaline, the blood pressure and rate of flow should be checked frequently to avoid hypertension, which may be associated with bradycardia as well as headache and peripheral ischemia, including rarely gangrene of the extremities.
Extravasation may cause local tissue necrosis (see section ‘Extravasation’ below). Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline may increase the ischaemia and extend the area of infarction, unless in the opinion of the attending physician, the administration of noradrenaline is necessary as a life-saving procedure.
Similar caution should be observed in patients with hypotension following myocardial infarction and in patients with angina, particularly Prinzmetal’s variant angina, diabetes, hypertension or hyperthyroidism. Caution is advised in patients with major left ventricular dysfunction associated with acute hypotension.
Supportive therapy should be initiated simultaneously with diagnostic evaluation. Noradrenaline should be reserved for patients with cardiogenic shock and refractory hypotension, in particular those without elevated systemic vascular resistance.
Occurrence of heart rhythm disorders during the treatment must lead to a reduction in the dosage. Cardiac arrhythmias may arise when noradrenaline is used in conjunction with cardiac sensitizing agents, and may be more likely in patients with hypoxia or hypercarbia.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised June 16, 2025[1]
1. 4). - Do not use with cyclopropane and halothane anaesthetics as this may cause serious cardiac arrhythmias including ventricular fibrillation. 5.
This is not medical advice. Consult a qualified healthcare professional.
Norepinephrine Bitartrate in 5% Dextrose Injection should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of Norepinephrine Bitartrate in 5% Dextrose Injection is necessary as a life-saving procedure.
Cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or levarterenol. Hence, the use of Norepinephrine Bitartrate in 5% Dextrose Injection during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation.
The same type of cardiac arrhythmias may result from the use of Norepinephrine Bitartrate in 5% Dextrose Injection in patients with Prescribing Information - Norepinephrine Bitartrate in 5% Dextrose Injection USP) Page 4 of 13 profound hypoxia or hypercarbia.
WARNING Norepinephrine Bitartrate in 5% Dextrose Injection should be used with extreme caution in patients receiving monoamine oxidase (MAO) inhibitors or antidepressants of the triptyline or imipramine types, because severe, prolonged hypertension may result.
Norepinephrine Bitartrate in 5% Dextrose Injection should be used with caution in the context of aneurysmal subarachnoid hemorrhage (SAH) due to the risk of overdose and associated adverse events. Whenever clinical symptoms rather worsen after the augmentation of blood pressure, reverse hypertensive therapy is advised.
PRECAUTIONS Avoid Hypertension:
Because of the potency of Norepinephrine Bitartrate in 5% Dextrose Injection and because of varying response to pressor substances, the possibility always exists that dangerously high blood pressure may be produced with overdoses of this pressor agent.
It is desirable, therefore, to record the blood pressure every two minutes from the time administration is started until the desired blood pressure is obtained, then every five minutes if administration is to be continued. The rate of flow must be watched constantly, and the patient should never be left unattended while receiving Norepinephrine Bitartrate in 5% Dextrose Injection.
Headache may be a symptom of hypertension due to overdosage.
Site of infusion:
Whenever possible, Norepinephrine Bitartrate in 5% Dextrose Injection should be given into a large vein, particularly an antecubital vein because, when administered into this vein, the risk of necrosis of the overlying skin from prolonged vasoconstriction is apparently very slight.
Some authors have indicated that the femoral vein is also an acceptable route of administration. A catheter tie-in technique should be avoided, if possible, since the obstruction to blood flow around the tubing may cause stasis and increased local concentration of the drug.
Occlusive vascular diseases (for example, atherosclerosis, arteriosclerosis, diabetic endarteritis, Buerger’s disease) are more likely to occur in the lower than in the upper extremity. Therefore, one should avoid the veins of the leg or dorsum of the hand in elderly patients, or in those suffering from such disorders.
Gangrene has been reported in a lower extremity when norepinephrine bitartrate was given in an ankle vein. Prescribing Information - Norepinephrine Bitartrate in 5% Dextrose Injection USP) Page 5 of 13 Extravasation: The infusion site should be checked frequently for free flow.
Care should be taken to avoid extravasation of Norepinephrine Bitartrate in 5% Dextrose Injection into the tissues, as local necrosis might ensue due to the vasoconstrictive action of the drug. Blanching along the course of the infused vein, sometimes without obvious extravasation, has been attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage.
This also may progress on rare occasions to superficial slough, particularly during infusion into leg veins, in elderly patients or in those suffering from obliterative vascular disease. Hence, if blanching occurs, consideration should be given to the advisability of changing the infusion site at intervals to allow the effects of local vasoconstriction to subside.
Norepinephrine administration was reported to induce fetal bradycardia most likely as a result of uterine/peripheral vasoconstriction by norepinephrine, however transplacental passage cannot be excluded. It was shown to exert a contractile effect on the pregnant uterus and may lead to fetal hypoxia […]
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. 125 mL per minute (from 2 mcg to 4 mcg of base).
1 Important Dosage and Administration Instructions Correct Hypovolemia Address hypovolemia before initiation of norepinephrine bitartrate injection therapy. 1) ] . 3) ] . Infuse norepinephrine bitartrate injection into a large vein. 1) ].
Avoid using a catheter-tie-in technique . Discontinuation When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal. 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.
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 vial (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.
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.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised June 17, 2025[3]
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.
gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised June 17, 2025[3]
5 WARNINGS AND 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.
1 ) Hypotension After Abrupt Discontinuation : Sudden cessation of the infusion rate may result in marked hypotension. Reduce the norepinephrine bitartrate injection infusion rate gradually. 2 ) Cardiac Arrhythmias: Norepinephrine bitartrate injection may cause arrhythmias.
Monitor cardiac function in patients with underlying heart disease. 3 ) Allergic Reactions with Sulfite: Norepinephrine bitartrate injection contains sodium metabisulfite. Sulfite may cause allergic-type-reactions. 1 Tissue Ischemia Administration of norepinephrine bitartrate 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.
1) ]. Avoid norepinephrine bitartrate 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 may cause necrosis and sloughing of surrounding tissue. 1) ]. 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.
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 infusion rate while expanding blood volume with intravenous fluids.
3 Cardiac Arrhythmias Norepinephrine bitartrate elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias.
4 Allergic Reactions Associated with Sulfite Norepinephrine bitartrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised June 17, 2025[3]
4 CONTRAINDICATIONS None. None. ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
The use of pressor amines with chloroform, enflurane or other halogenated anaesthetics may cause serious cardiac arrhythmias. 5). 3). 5). Special caution should be used for patients with liver failure, severe renal dysfunction, ischemic heart diseases and elevated intracranial pressure.
, hyperthyroid patients) may cause severe hypertension with violent headache, photophobia, stabbing retrosternal pain, pallor, intense sweating and vomiting. Hypertension may eventually lead to acute pulmonary edema, arrhythmia or cardiac arrest.
Care should be taken in diabetics as it increases the level of blood glucose (due to the glycogenolytic action in the liver and the inhibition of insulin release from the pancreas). Elderly patients may be especially sensitive to the effects of noradrenaline due to the greater frequency of hepatic, renal or cardiac dysfunction and concomitant disease or other drug therapy.
2). Noradrenaline should only be used by doctors familiar with the selective indications for its use. Where indicated, appropriate replacement therapy of blood or fluid together with adoption of the supine position with elevation of the legs, must be instituted and maintained prior to and/or during therapy with this product.
When infusing noradrenaline, the blood pressure and rate of flow should be checked frequently to avoid hypertension. Therefore, it is desirable to record the blood pressure every two minutes from the time the administration started until the desired blood pressure is obtained and then every five minutes thereafter, if the administration is to be continued.
The rate of flow must be watched constantly and the patient should never be left unattended while receiving noradrenaline. Hypertension may eventually lead to acute pulmonary oedema, arrhythmia or cardiac arrest. The infusion of noradrenaline should be stopped gradually as sudden cessation may produce a catastrophic fall in blood pressure.
The vasopressor effect (resulting from the adrenergic action on the vessels) can be reduced by the concomitant administration of an alpha-blocking agent whereas the administration of a beta-blocking agent may result […]