Advanced search

Report side effect

Report a suspected side effect or falsified product to the MHRA Yellow Card scheme.
Go to {yellow_card_logo} site
{arrow_up} Back to top

Metaraminol 10mg/ml Solution for Injection or Infusion

Active Ingredient:
metaraminol tartrate
Company:  
Aspire Pharma Ltd See contact details
ATC code: 
C01CA09
{info_black}
About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 27 Feb 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL35533/0167.

Metaraminol 10mg/ml Solution for Injection or Infusion

Package leaflet: Information for the user

Metaraminol 10mg/ml Solution for Injection or Infusion

metaraminol tartrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, nurse or pharmacist.
  • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Metaraminol is and what it is used for
2. What you need to know before you are given Metaraminol
3. How to use Metaraminol
4. Possible side effects
5. How to store Metaraminol
6. Contents of the pack and other information

1 What Metaraminol is and what it is used for

This medicine contains the active substance Metaraminol tartrate, which belongs to a group of medicines called “vasopressors”. These medicines work by narrowing the blood vessels causing blood pressure to rise.

This medicine is used to treat low blood pressure that can occur during spinal or epidural anaesthesia.

2 What you need to know before you use Metaraminol

You will be given this medicine in hospital by a doctor or nurse.

Do not use Metaraminol:
  • if you are allergic to metaraminol tartrate or any of the other ingredients of this medicine (listed in section 6).
  • if you are being given certain types of anaesthetics (halothane or cyclopropane), unless your doctor sees a clinical need to do so.
  • if you have low blood pressure caused by low blood volume.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Metaraminol if you suffer from or have suffered in the past from any of the following conditions:

  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes mellitus
  • A history of malaria

Children

Do not use this medicine in children below the age of 12 years.

Other medicines and Metaraminol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important if you are taking:

  • Digitalis medicines (such as digoxin) which may cause an irregular heartbeat.
  • Monoamine oxidase inhibitors which may increase the action of metaraminol.
  • Anaesthetics such as cyclopropane or halothane.
  • Oxytocin, a drug used to prevent or control bleeding after delivery of your baby.

Pregnancy, breast-feeding and fertility

Pregnancy

The effects of this medicine on the unborn baby are unknown. It is not known whether this medicine is present in breast milk. You will only be given this medicine if your doctor sees the clinical need to do so in an emergency situation.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

Information on sodium content

This medicine contains less than 1 mmol sodium (23mg) per 10mg/ml ampoule, that is to say essentially ‘sodium free’.

3 How to use Metaraminol

This medicine will be given to you in a hospital as an injection into a vein or diluted before use and given with fluid into a vein.

Your doctor will decide on the correct dosage for you and how and when the medicine will be given.

Direct Intravenous injection (in grave emergencies)

The initial dose is 0.5 – 5mg metaraminol, followed by an infusion of 15 – 100mg metaraminol, in a diluent, made up to a total volume of 500ml.

Intravenous infusion:

15 – 100mg in 500ml Sodium Chloride Injection or Glucose 5% Injection. Higher concentrations of Metaraminol have been used when appropriate to the circumstances.

If you are given too much Metaraminol

In the event you are given too much Metaraminol, you may experience high blood pressure accompanied by a headache, a tight feeling in the chest, nausea, vomiting, euphoria, sweating, fluid in the lungs, increased or decreased heart rate, irregular heartbeat, heart attack, heart failure, or convulsions (fits).

Tell your doctor immediately if you feel unwell. Treatment with this medicine may subsequently be stopped, and if needed, an antidote will be administered by medical staff.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of possible side effects are listed below.

Tell your doctor immediately if you experience:

Very Common

(may affect more than 1 in 10 people):

  • Headache
  • High blood pressure

Rare (may affect up to 1 in 1,000 people):

  • Abscess or peeling skin at the site of injection, or an area where the tissue around the injection site dies

Not known

(Frequency cannot be estimated from available data):

  • Fatal changes in heart rhythm in patients suffering from liver cirrhosis
  • Changes in heartbeat including slower or faster heart rates or palpitations
  • Reduced blood supply to the arms and legs (including hands and feet)
  • Feeling sick

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Metaraminol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the ampoule and the carton after “EXP”. The expiry date refers to the last day of that month. Before use, the doctor or nurse will check the medicine has not passed this date and that the medicine does not show any sign of deterioration.

After the expiry date return any unused medicine to a pharmacy.

Do not throw away any medicines via waste water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the enviroment.

Only use this medicine if it is particle free.

This medicine is for single use only.

Store this medicine at 25°C or below. Do not freeze. If diluted in a sterile environment, the medicine can be stored for 24 hours between 2 to 8°C.

Store ampoules in the outer carton in order to protect from light.

6 Contents of the pack and other information
What Metaraminol contains

The active substance is Metaraminol Tartrate (1.9% w/v), which is equivalent to 1% w/v (10mg/ml) Metaraminol. The other ingredients are: Sodium Chloride, Citric acid monohydrate (pH adjuster), Glacial acetic acid, Sodium acetate trihydrate, Disodium edetate and Water for Injections

What Metaraminol looks like and contents of the pack

This medicine is a clear, colourless solution in a 1ml clear glass ampoule.

This medicine is packed into cartons containing 5 ampoules.

Marketing Authorisation Holder
Aspire Pharma Limited
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom

Manufacturer
SALF SpA Laboratorio Farmacologico
Via G. Mazzini, 9
24069 Cenate Sotto (Bergamo)
Italy

This leaflet was last revised in February 2022

P1.4

Aspire Pharma Ltd
Company image
Address
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
Telephone
+44 (0)1730 231148
Medical Information Direct Line
+44 (0)1730 231148
Customer Care direct line
+44 (0)1730 231148