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 Metaraminol tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for irregular heartbeat; 2. What you need to know before you are given Metaraminol
milk. You will only be given this medicine if your doctor sees Metaraminol injection the clinical need to do so in an emergency situation. You will be given this medicine in hospital by a doctor or Driving and using machines nurse. Metaraminol injection may affect your ability to drive or You should not be given this medicine: operate machines. Ask your doctor about when it would be
The following information is intended for healthcare professionals only: Therapeutic indications For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and as an adjunct to accepted remedial procedures. Posology and method of administration For intravenous use. The pre-illed syringe is not suitable for syringe pump drivers. Direct intravenous injection in grave emergencies: 0.5 – 5 mg (1 to 10 ml). Bolus doses should be administered at the minimal eficient dose. The maximum cumulative dose after repeated direct intravenous injections is 5mg. One direct IV injection should usually not exceed 1mg. Direct intravenous injection may be followed by an infusion of 15 – 100 mg in 500 mL of infusion liquid, using an appropriate metaraminol formulation and administration. Metaraminol 0.5 mg/ml solution for injection in pre-illed syringe is not suitable for intravenous infusion. Metaraminol 0.5 mg/ml, solution for injection should not be diluted before use: it is supplied ready to use in pre-illed syringes. The contents of the syringe should not be added to infusion luids. Metaraminol should be administered under comprehensive hemodynamic monitoring. In case of extravasation, local administration of an alpha blocker such as Phentolamine may prevent the risk of necrosis. Children: Metaraminol should not be used in children under 12 years of age. Use in the elderly: The dosage may not require modiication for elderly patients; however, geriatric patients may be more sensitive to sympathomimetic agents, therefore particular caution should be taken in this age group. Please prepare the syringe carefully as follows The pre-illed syringe is for single patient only. Discard syringe after use. DO NOT REUSE. The content of an un-opened and un-damaged blister is sterile, and the blister must not be opened until the syringe is ready to be used. The product should be inspected visually for particles and discoloration prior to administration. Only a clear colourless solution free from particles or precipitates should be used. The product should not be used if the tamper evident seal on the syringe is broken. The external surface of the syringe is sterile until the blister is opened.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects may be serious. Seek immediately medical help if you experience the following symptoms that may be due to severely high blood pressure:
Metaraminol injection
This medicine will be administered by a healthcare professional with appropriate training and relevant experience. Your doctor will decide the most suitable dosage for your particular case according to your age and medical condition, as well as for the site of injection, and your response to the injection. If you receive more Metaraminol injection than you should Since this medicine is administered to you by a trained healthcare professional, it is unlikely that you will be given too much of Metaraminol injection. You will be carefully monitored by your doctor for symptoms or severely high blood pressure (see symptoms in Section 4 Possible Side Effects). If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Keep this medicine out of the sight and reach of children. You should not be given this medicine after the expiry date which is stated on the syringe label, blister and carton. The expiry date refers to the last day of that month. Your doctor or nurse will check this. Keep the syringe in its unopened blister until use. Do not freeze. Do not use this medicine if you notice visible signs of deterioration. Any syringe, even partially used, should be discarded appropriately after use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Metaraminol injection contains The active substance is Metaraminol tartrate:
1) Withdraw the pre-illed syringe from the sterile blister.
2) Push on the plunger to free the bung. The sterilisation process may have caused adhesion of the bung to the body of the syringe.
3) Twist off the end cap to break the seal. Do not touch the exposed luer connection in order to avoid contamination.
4) Check the syringe seal tip has been completely removed. If not, replace the cap and twist again.
5) Expel the air by gently pushing the plunger.
6) Connect the syringe to the vascular access device. Push the plunger slowly to inject the required volume.
Metaraminol 0.5 mg/ml, Solution for Injection in pre-filled syringe comes as injection containing 0.5mg/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 Metaraminol 0.5 mg/ml, Solution for Injection in pre-filled syringe is metaraminol tartrate.
Medicines with the same active substance, strength and form include: Metaraminol 0.5mg/mL Solution for Injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Metaraminol 0.5 mg/ml, Solution for Injection in pre-filled syringe, 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.
For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and as an adjunct to accepted remedial procedures.
Posology
Adults
Direct intravenous injection in grave emergencies: 0.5 to 5 mg (1 to 10 ml).
The maximum cumulative dose after repeated direct intravenous injections is 5mg. One direct IV injection should usually not exceed 1mg.
Direct intravenous injection may be followed by an infusion of 15 - 100 mg in 500 mL of infusion liquid, using an appropriate metaraminol formulation and administration.
Metaraminol 0.5 mg/ml solution for injection in pre-filled syringe is not suitable for intravenous infusion.
Paediatric population
Metaraminol should not be used in children under 12 years of age.
Elderly
The dosage may not require modification for elderly patients; however, geriatric patients may be more sensitive to sympathomimetic agents, therefore particular caution should be taken in this age group.
Method of administration
For intravenous use.
Metaraminol 0.5 mg/ml, solution for injection should not be diluted before use: it is supplied ready to use in pre-filled syringes.
The pre-filled syringe is not suitable for syringe pump drivers.
Metaraminol, solution for injection in pre-filled syringe should not be used concurrently with cyclopropane or halothane anaesthesia, unless clinical circumstances demand it.
Metaraminol, solution for injection in pre-filled syringe is contra-indicated in patients who are hypersensitive to the active ingredient or any of the excipients listed in section 6.1.
There is insufficient data to recommend use in children under 12 years of age
Caution should be exercised to avoid excessive blood-pressure changes since response to treatment with metaraminol is very variable and the ensuing control of the blood pressure may prove difficult.
Rapidly induced hypertensive responses have been reported to cause acute pulmonary oedema, cardiac arrhythmias and arrest. Metaraminol should be used with caution in patients with cirrhosis; electrolyte levels should be adequately restored if a diuresis ensues. A fatal ventricular arrhythmia was reported in a patient with Laennec's cirrhosis while receiving metaraminol tartrate. In several instances ventricular extrasystoles that appeared during infusion of metaraminol promptly subsided when the rate of flow was reduced.
With the prolonged action of Metaraminol, a cumulative effect is possible. An excessive vasopressor response may cause a prolonged elevation of blood pressure, even after discontinuation of therapy. Metaraminol should be used with caution in cases of heart disease, hypertension, thyroid disease or diabetes mellitus because of the vasoconstrictor action.
Sympathomimetic amines may provoke a relapse in patients with a history of malaria.
When vasopressor amines are used for long periods, the resulting vasoconstriction may prevent adequate expansion of circulating volume and may cause perpetuation of the shock state. There is evidence that plasma volume may be reduced in all types of shock, and that the measurement of central venous pressure is useful in assessing the adequacy of the circulating blood volume. Blood, or plasma-volume expanders, should therefore be employed when the principal reason for hypotension of shock is decreased circulating volume.
In choosing the site for injection, it is important to avoid those areas generally recognised as being unsuitable for the use of any pressor agent. Although the urgent nature of the patient's condition may force the choice of an unsuitable injection site, the preferred areas of injection should be used when possible. The larger veins of the antecubital fossa or thigh are preferred to the veins in the ankle or dorsum of the hand, particularly in patients with peripheral vascular disease, diabetes mellitus, Buerger's disease or conditions with coexistent hypercoagulability.
In case of extravasation, local administration of an alpha blocker such as Phentolamine may prevent the risk of necrosis.
Metaraminol, solution for injection in pre-filled syringe is to be used by direct intravenous injection only. Bolus doses should be administered at the minimal efficient dose. Metaraminol should be administered under comprehensive hemodynamic monitoring.
This medicinal product contains 35 mg sodium per 10 ml syringe, equivalent to 1.8 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Metaraminol, solution for injection in pre-filled syringe should not be used concurrently with cyclopropane or halothane anaesthesia, unless clinical circumstances demand it, due to a risk of serious venticular arrhythmia.
Metaraminol should be used with caution in patients receiving digitalis, since the combination of digitalis and sympathomimetic amines is capable of causing ectopic arrhythmic activity.
Monoamine oxidase inhibitors have been reported to potentiate the action of sympathomimetic amines. The pressor effect of metaraminol is decreased but not reversed by alpha-adrenergic blocking agents.
A close monitoring of blood pressure is recommended in case of co-administration with oxytocic drugs due to the risk of enhancement of metaraminol effects.
In case of co-administration of metaraminol and ergot alkaloids, there is a risk of vasoconstriction and/or hypertensive crisis.
Co-administration with tricyclic antidepressants may enhance the effect of metaraminol.
Co-administration with doxapram may enhance the effect of metaraminol.
Co-administration with Guanethidine may alter the effects of both medications.
Pregnancy
There are no well-controlled studies in pregnant women. Metaraminol should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Breastfeeding
It is not known whether metaraminol is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if metaraminol is given to a breastfeeding mother.
Fertility
There are no fertility data available.
Not relevant.
The frequency of adverse events with metaraminol has not been firmly established.
Excessive therapeutic effect leading to hypertension, quickly reversible by reducing the rate of infusion, and headaches are very common.
Adverse reactions listed below are classified according to frequency and system organ class (SOC). The frequencies of adverse reactions are ranked according to the following convention: Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
not known (cannot be estimated from the available data)
Psychiatric disorders
Anxiety, fear, confusion, irritability, psychotic state
Nervous system disorders
Headache
Restlessness, dizziness, insomnia
Cardiac disorders
Palpitations; sinus or ventricular tachycardia; bradycardia; other cardiac arrhythmias (especially in patients with myocardial infarction); fatal ventricular arrhythmia reported in Laennec's cirrhosis
Vascular disorders
Hypertension
Flushing, rebound hypotension, peripheral ischaemia
Gastrointestinal disorders
Nausea, vomiting
Renal and urinary disorders
Difficulty in micturition, urinary retention
General disorders and administration site conditions
Abscess formation; tissue necrosis; sloughing
Sweating
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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Metaraminol acts rapidly. The major therapeutic effects are complete within an hour of parenteral administration. Overdosage may result in severe hypertension accompanied by headache, constricting sensation in the chest, nausea, vomiting, euphoria, diaphoresis, pulmonary oedema, tachycardia, bradycardia, sinus arrhythmia, atrial or ventricular arrhythmias, myocardial infarction, cardiac arrest, convulsions or cerebral haemorrhage.
If the drug has been ingested, induce emesis or perform gastric lavage. If metaraminol has been administered by subcutaneous or intramuscular injection, local ice packs may be applied to delay absorption.
If needed, alpha-adrenergic blocking agents may also be useful for reducing hypertension and may have a beneficial effect on cardiac arrhythmia, if present.
Parenteral diazepam may be given for convulsions.
Ask anything about Metaraminol 0.5 mg/ml, Solution for Injection in pre-filled syringe. 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.
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