Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Noradrenaline tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Noradrenaline (Norepinephrine) Concentrate for Solution for Infusion is used in an emergency to increase blood pressure to normal levels.
Noradrenaline (Norepinephrine) Concentrate Do not take Noradrenaline (Norepinephrine) Concentrate
Page 1 of 5
Other medicines and Noradrenaline Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. A number of medicines are known to increase the toxic effects of noradrenaline, such as:
Noradrenaline (Norepinephrine) Concentrate contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially 'sodium-free'. The 2 ml ampoule contains 6.7 mg sodium, and the 4 ml ampoule contains 13.3 mg sodium. This medicine may be diluted with sodium-containing solutions. Take into consideration if you are on a low-sodium diet.
Noradrenaline (Norepinephrine) Concentrate Noradrenaline (Norepinephrine) Concentrate will be given to you in hospital by a doctor or nurse. It is first diluted and then infused into a vein. The recommended dose of Noradrenaline (Norepinephrine) Concentrate will depend on your medical condition. The usual dose is between 0.4 and 0.8 mg per hour. Your doctor will determine the correct dose for you. After the initial dose your doctor will assess your response and adjust the dose accordingly. If you are given more or forget to take Noradrenaline (Norepinephrine) Concentrate: It is unlikely that you will receive too much or too little of this medicine, as this medicine will be given to you in hospital. However, talk to your doctor or nurse if you have any concerns. Symptoms of overdose are severe high blood pressure, slow heartbeat, violent headache, difficulty breathing due to fluids in the lungs, light sensitivity, pain in the chest, pale colour, intense sweating and vomiting.
Page 2 of 5
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience:
Noradrenaline (Norepinephrine) Concentrate Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. From a microbiological point of view, the product should be used immediately after dilution. Do not use this medicine if the solution is brown in colour. Do not throw away any medicines via wastewater. Ask your pharmacists how to throw away medicines you no longer use. These measures will help protect the environment.
What Noradrenaline (Norepinephrine) contains The active substance is noradrenaline (as noradrenaline tartrate). 1 ml concentrate for solution for infusion contains 2 mg noradrenaline tartrate equivalent to 1 mg noradrenaline base. 1 ampoule of 2 ml contains 4 mg noradrenaline tartrate equivalent to 2 mg noradrenaline base. 1 ampoule of 4 ml contains 8 mg noradrenaline tartrate equivalent to 4 mg noradrenaline base.
Page 3 of 5
The other ingredients are:
UK Manufacturers Avara Liscate Pharmaceutical Services S.p.A. Via Fosse Ardeatine 2 20050 Liscate – Milan Italy This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Finland and Sweden: United Kingdom (Northern Ireland):
Noradrenalin Pfizer Noradrenaline (Norepinephrine)
This leaflet was last revised in 03/2024. Ref: gxNO 8_0 —————————————————————————————————————Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion The following information is intended for healthcare professionals only: For intravenous use. Dilute before use. Administer as a diluted solution via a central venous catheter. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.
Page 4 of 5
Incompatibilities Infusion solutions containing noradrenaline tartrate have been reported to be incompatible with the following substances: alkalis and oxidising agents, barbiturates, chlorpheniramine, chlorothiazide, nitrofurantoin, novobiocin, phenytoin, sodium bicarbonate, sodium iodide, streptomycin.
Dilution instructions Dilute before use with glucose 5% solution or sodium chloride 9 mg/ml (0.9%) with glucose 5% solution. Either add 2 ml of concentrate to 48 ml glucose 5% solution (or sodium chloride 9 mg/ml (0.9%) with glucose 5% solution) for administration by syringe pump, or add 20 ml of concentrate to 480 ml glucose 5% solution (or sodium chloride 9 mg/ml (0.9%) with glucose 5% solution) for administration by drip counter. In both cases the final concentration of the infusion solution is 40 mg/litre noradrenaline base (which is equivalent to 80 mg/litre noradrenaline tartrate). Dilutions other than 40 mg/litre noradrenaline base may also be used. If dilutions other than 40 mg/litre noradrenaline base are used, check the infusion rate calculation carefully before starting treatment. The product is compatible with PVC infusion bags. Any unused product or waste material should be disposed of in accordance with local requirements. Shelf life after dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C when diluted to 4 mg/litre and 40 mg/litre noradrenaline base in sodium chloride 9 mg/ml (0.9%) solution or glucose 5% solution. However, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Page 5 of 5
Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion comes as infusion containing 1mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion is noradrenaline tartrate.
Medicines with the same active substance, strength and form include: Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion, Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Indicated for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension.
Posology
Adults
Initial rate of infusion:
When diluted as recommended in section 6.6 (the concentration of the prepared infusion is 40 mg/litre noradrenaline base (80 mg/litre noradrenaline tartrate)) the initial rate of infusion, at a body weight of 70 kg, should be between 10 ml/hour and 20 ml/hour (0.16 to 0.33 ml/min). This is equivalent to 0.4 mg/hour to 0.8 mg/hour noradrenaline base (0.8 mg/hour to 1.6 mg/hour noradrenaline tartrate). Some clinicians may wish to start at a lower initial infusion rate of 5 ml/hour (0.08 ml/min), equivalent to 0.2 mg/hour noradrenaline base (0.4 mg/hour noradrenaline tartrate).
Titration of dose:
Once an infusion of noradrenaline has been established the dose should be titrated in steps of 0.05 -0.1 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).
Noradrenaline Infusion Solution
40 mg/litre (40 µg /ml) noradrenaline base
Patient's Weight
Posology (µg/kg/min) noradrenaline base
Posology (mg/hour)
noradrenaline base
Infusion Rate (ml/hour)
50 kg
0.05
0.15
3.75
0.1
0.3
7.5
0.25
0.75
18.75
0.5
1.5
37.5
1
3
75
60 kg
0.05
0.18
4.5
0.1
0.36
9
0.25
0.9
22.5
0.5
1.8
45
1
3.6
90
70 kg
0.05
0.21
5.25
0.1
0.42
10.5
0.25
1.05
26.25
0.5
2.1
52.5
1
4.2
105
80 kg
0.05
0.24
6
0.1
0.48
12
0.25
1.2
30
0.5
2.4
60
1
4.8
120
90 kg
0.05
0.27
6.75
0.1
0.54
13.5
0.25
1.35
33.75
0.5
2.7
67.5
1
5.4
135
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.
Renal or hepatic impairment:
There is no experience in treatment of renally or hepatically impaired patients.
Elderly:
As for adults but see section 4.4.
Paediatric population
Not recommended.
Duration of Treatment and Monitoring:
Noradrenaline should be continued for as long as vasoactive drug support is indicated. The patient should be monitored carefully for the duration of therapy. Blood pressure should be carefully monitored for the duration of therapy.
Withdrawal of Therapy:
The noradrenaline infusion should be gradually decreased since abrupt withdrawal can result in acute hypotension.
Route of Administration:
For intravenous use.
Method of administration:
Administer as a diluted solution via a central venous catheter.
The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to noradrenaline tartrate or to any of the excipients listed in section 6.1.
Noradrenaline should only be administered by healthcare professionals who are familiar with its use.
Elderly patients may be especially sensitive to the effects of noradrenaline.
Particular caution should be observed in patients with coronary, mesenteric or peripheral vascular thrombosis because noradrenaline may increase the ischemia and extend the area of infarction. Similar caution should be observed in patients with hypotension following myocardial infarction, in patients with Prinzmetal's variant angina and in patients with diabetes, hypertension or hyperthyroidism.
Noradrenaline should be used with caution in patients who exhibit profound hypoxia or hypercarbia.
Noradrenaline should be used only in conjunction with appropriate blood volume replacement. When infusing noradrenaline, the blood pressure and rate of flow should be checked frequently to avoid hypertension.
Extravasation of the solution may cause local tissue necrosis. The infusion site should be checked frequently. If extravasation occurs, the infusion should be stopped and the area should be infiltrated with phentolamine without delay.
Prolonged administration of any potent vasopressor may result in plasma volume depletion which should be continuously corrected by appropriate fluid and electrolyte replacement therapy. If plasma volumes are not corrected, hypotension may recur when the infusion is discontinued, or blood pressure may be maintained at the risk of severe peripheral and visceral vasoconstriction (e.g., decreased renal perfusion) with diminution in blood flow and tissue perfusion with subsequent tissue hypoxia and lactic acidosis and possible ischaemic injury.
Excipient with known effects
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'.
This medicinal product may be diluted with sodium-containing solutions (see sections 4.2 and 6.6) and this should be considered in relation to the total sodium from all sources that will be administered to the patient.
The use of noradrenaline with volatile halogenated anaesthetic agents, monoamine oxidase inhibitors, linezolid, tricyclic antidepressants, adrenergic-serotoninergic drugs or any other cardiac sensitising agents is not recommended because severe, prolonged hypertension and possible arrhythmias may result.
The effects of noradrenaline may be enhanced by guanethidine.
Pregnancy
Noradrenaline may impair placental perfusion and induce fetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy. These possible risks to the fetus should therefore be weighed against the potential benefit to the mother.
Breastfeeding
No information is available on the use of noradrenaline in lactation.
None stated.
System Organ Class
Undesirable effect
Psychiatric disorders
Anxiety
Nervous system disorders
Headache
Cardiac disorders
Arrhythmias (when used in conjunction with cardiac sensitising agents), bradycardia, stress cardiomyopathy
Vascular disorders
Hypertension, peripheral ischaemia including gangrene of the extremities, plasma volume depletion with prolonged use
Respiratory, thoracic and mediastinal disorders
Dyspnoea
General disorders and administration site conditions
Extravasation necrosis at injection site
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. Healthcare professionals are asked to report any suspected adverse reactions via the UK Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdosage may result in severe hypertension, reflex bradycardia, marked increase in peripheral resistance and decreased cardiac output. These may be accompanied by violent headache, pulmonary oedema, photophobia, retrosternal pain, pallor, intense sweating and vomiting. In the event of overdosage, treatment should be withdrawn and appropriate corrective treatment initiated.
Ask anything about Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.