Consumer medicine information

Metaraminol Myx

Metaraminol

BRAND INFORMATION

Brand name

Metaraminol MYX

Active ingredient

Metaraminol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Metaraminol Myx.

What is in this leaflet

This leaflet answers some common questions about Metaraminol MYX® Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Metaraminol MYX® Injection against the benefits it is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Metaraminol MYX® Injection is used for

The name of your medicine is Metaraminol MYX® Injection. It contains the active ingredient Metaraminol tartrate.

Metaraminol tartrate belongs to a group of medicines known as sympathomimetic amines. It strengthens the contraction of the heart muscle and constricts blood vessels to help increase the blood pressure.

Metaraminol MYX® Injection is used to increase your blood pressure which can drop during spinal anaesthesia or can drop as a reaction to medications or surgical complications.

Ask your doctor if you have any questions about why Metaraminol MYX® Injection has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription. This medicine is not addictive.

Before you are given Metaraminol MYX® Injection

When you must not be given it

You should not be given Metaraminol MYX® Injection if you have an allergy to:

  • the active ingredient
  • any of the inactive ingredients mentioned at the end of this leaflet.

Symptoms of an allergic reaction include:

  • rash, asthma attack or hay fever
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You should not be given Metaraminol MYX® Injection if:

  • you are being given cyclopropane or halothane anaesthesia (unless clinical circumstances demand their use).
  • it is past its expiry date or the packaging appears to have been tampered with.

Metaraminol MYX® Injection is not recommended for children.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver disease
  • heart or thyroid disease
  • high blood pressure
  • diabetes
  • malaria.

Tell your doctor if you are pregnant or plan on becoming pregnant or are breast-feeding while you are being given Metaraminol MYX® Injection. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you are given Metaraminol MYX® Injection.

Taking other medicines

Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Metaraminol MYX® Injection may interfere with each other.

These include:

  • certain medicines used to treat depression, e.g. Monoamine Oxidase Inhibitors (MAOI’s) or Tricyclic antidepressants (TCA’s)
  • digoxin, a medicine used to treat heart failure.

If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist.

These medicines may be affected by Metaraminol MYX® Injection or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

How to Metaraminol MYX® Injection is given

How much is given

The dose of Metaraminol MYX® Injection you will receive depends on your medical condition and other factors such as your weight.

How it is given

Metaraminol MYX® Injection is administered in a hospital as an injection into a vein or is diluted before use and given with fluids into a vein. This medicine must only be given by a doctor or nurse.

To reduce microbial hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2-8°C for not more than 24 hours. The injection solution contains no antimicrobial preservative and is for single use in one patient only. Discard any residue.

If you are given too much (overdose)

Metaraminol MYX® Injection is administered in a hospital, under the supervision of a doctor. Therefore it is unlikely that you will receive too much. However, you should tell your doctor or nurse immediately if you feel unwell at all whilst you are being given Metaraminol MYX® Injection. You may need urgent medical attention.

While you are being given Metaraminol MYX® Injection

Things you must do

  • Always follow your doctor’s instructions carefully.
  • Your doctor or nurse will monitor your blood pressure.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Metaraminol MYX® Injection.

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not.

Tell your doctor immediately if you notice the following:

  • fast or pounding heartbeat.

This may be a serious side effect of Metaraminol MYX® Injection. You may need urgent medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • breathlessness or any difficulty breathing.

These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

Tell your doctor if you notice anything that is making you fell unwell.

Other side effects not listed above may also occur in some people.

After being given Metaraminol MYX® Injection

Storage

Metaraminol MYX® Injection should only be given to you in a hospital.

It should be kept in the original packaging until it has been given to you.

Metaraminol MYX® Injection must be stored below 25°C. Protect from light.

Disposal

Any unused or out of date medicine should be returned to your pharmacist.

Product description

What Metaraminol MYX® Injection looks like

Metaraminol MYX® Injection is a clear, colourless sterile solution. It is supplied in a pack of 5 yellow glass ampoules. Each ampoule contains 1 mL of solution.

Ingredients

Active Ingredient

Each ampoule (1 mL) of Metaraminol MYX® Injection contains metaraminol tartrate equivalent to 10 mg of Metaraminol.

Inactive Ingredients

Each ampoule (1 mL) of Metaraminol MYX® Injection also contains sodium chloride 4.7 mg, citric acid monohydrate 0.1 mg, glacial acetic acid 1 mg, sodium acetate trihydrate 0.5 mg, disodium edetate 0.5 mg in water for injections to 1 mL.

Supplier

Metaraminol MYX® Injection is supplied in Australia by:

Mayne Pharma International Pty Ltd
ABN 88 007 870 984
1538 Main North Road
Salisbury South, SA 5106

This leaflet was prepared in February 2020.

Australian Register Number

Metaraminol MYX® Injection 10mg/1mL: AUST R 310904

MYX is a registered trade mark of Mayne Pharma International Pty Ltd.

Published by MIMS June 2021

BRAND INFORMATION

Brand name

Metaraminol MYX

Active ingredient

Metaraminol

Schedule

S4

 

1 Name of Medicine

Metaraminol tartrate.

2 Qualitative and Quantitative Composition

Metaraminol MYX Injection contains metaraminol tartrate equivalent to 10 mg/mL metaraminol.
Metaraminol tartrate is a white, crystalline powder, which is freely soluble in water, slightly soluble in alcohol, and practically insoluble in chloroform and in ether.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Metaraminol MYX Injection is a clear colourless sterile solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.
It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

4.2 Dose and Method of Administration

Metaraminol MYX Injection is administered intravenously only (injection or infusion). The injection solution contains no antimicrobial preservative and is for single use in one patient only. Discard any residue.
Because the maximum effect is not immediately apparent, at least ten minutes should elapse before increasing the dosage. As the effect tapers off when the vasopressor is discontinued, the patient should be carefully observed so that therapy can be reinitiated promptly if the blood pressure falls too rapidly. Patients with coexistent shock and acidosis may show a poor response to vasopressors. Established methods of shock management, such as blood or fluid replacement when indicated, and other measures directed to the specific cause of the shock also should be used.

Intravenous infusion. (For adjunctive treatment of hypotension).

The recommended dose is 15 to 100 mg (1.5 to 10 mL) in 500 mL of sodium chloride injection or glucose injection 5%, adjusting the rate of infusion to maintain the blood pressure at the desired level.
Higher concentrations of metaraminol tartrate (150 to 500 mg/500 mL of infusion fluid) have been used.
If the patient needs additional saline or glucose solution at a rate of flow that would provide an excessive dose of the vasopressor, the recommended volume (500 mL) of infusion fluid should be increased accordingly. Conversely, if a smaller volume of infusion fluid is desirable, the required dose of metaraminol tartrate may be added to less than 500 mL of diluent.

Compatibility.

Both sodium chloride injection 0.9% and glucose injection 5% were found physically and chemically compatible with metaraminol when 1.5 to 10 mL of metaraminol injection, 10 mg/mL (metaraminol equivalent), was added to 500 mL of infusion solution.
When metaraminol injection is mixed with an infusion solution, sterile precautions should be observed. To reduce microbiological hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2-8°C for not more than 24 hours.
The injection solution contains no antimicrobial preservative and is for single use in one patient only. Discard any residue.

Direct intravenous injection.

In severe shock, when time is of great importance, it may be desirable to administer metaraminol by direct intravenous injection. The suggested dose is 0.5 to 5 mg (0.05 to 0.5 mL), followed by an infusion of 15 to 100 mg (1.5 to 10 mL) in 500 mL of diluent. Direct intravenous injection of undiluted solution should be employed only in instances of grave emergency when prompt action is imperative to save life. Extreme care must be exercised to give the proper dose.

4.3 Contraindications

Use with cyclopropane or halothane anaesthesia should be avoided, unless clinical circumstances demand such use.
Hypersensitivity to any component of this product.

4.4 Special Warnings and Precautions for Use

Caution should be exercised to avoid an excessive blood pressure response. Rapidly induced hypertensive responses have been reported to cause acute pulmonary oedema, cardiac arrhythmias and arrest. Patients with cirrhosis should be treated with caution, with adequate restoration of electrolytes if diuresis ensues. A fatal ventricular arrhythmia has been reported in a patient with Laennec's cirrhosis while receiving metaraminol tartrate. In several instances, ventricular extrasystoles that appeared during infusion subsided promptly when the rate of flow was reduced.
With the prolonged action of this drug, a cumulative effect is possible, and with an excessive vasopressor response there may be a prolonged elevation of blood pressure even when therapy with metaraminol tartrate is discontinued.
Because of its vasoconstrictor effect, metaraminol tartrate should be given with caution in the presence of heart or thyroid disease, hypertension, or diabetes. 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 the 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. Therefore, blood or plasma volume expanders should be employed when the principal reason for hypotension or shock is decreased circulating volume.
In choosing the site of injection, it is important to avoid those areas recognised as unsuitable for the use of any pressor agent, and to discontinue the infusion immediately if infiltration or thrombosis occurs. 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 the dorsum of the hand, particularly in patients with Metaraminol MYX peripheral vascular disease, diabetes mellitus, Buerger's disease, or conditions with coexistent hypercoagulability.

Use in the elderly.

No data available.

Paediatric use.

The effect of therapy with Metaraminol MYX Injection in children has not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Metaraminol MYX Injection should be used with caution in digitalised patients, since the combination of digitalis and sympathomimetic amines is capable of causing ectopic arrhythmic activity.
Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants have been reported to potentiate the action of sympathomimetic amines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Drugs which, owing to their pharmacologic effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
There are no well controlled studies in pregnant women. Metaraminol may cause foetal hypoxia by constricting the uterine vessels thereby limiting placental perfusion.
Metaraminol MYX Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
 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 MYX Injection is given to a breastfeeding woman

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Abscess formation, tissue necrosis or sloughing rarely follow the use of metaraminol tartrate.
Sympathomimetic amines, including metaraminol tartrate, may cause sinus or ventricular tachycardia or other arrhythmias, especially in patients with myocardial infarction.

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration 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 at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

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 or convulsions.
Should an excessive elevation of blood pressure occur, it may be immediately relieved by a sympatholytic agent, e.g. phentolamine. An appropriate antiarrhythmic agent may also be required.
The oral LD50 in the rat and mouse is 240 mg/kg and 99 mg/kg, respectively.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Metaraminol is a potent sympathomimetic amine that increases both systolic and diastolic blood pressure. The pressor effect begins one to two minutes after intravenous injection, about ten minutes after intramuscular injection, 5 to 20 minutes after subcutaneous injection, and lasts about 20 minutes to one hour. Metaraminol has a positive inotropic effect on the heart and has a peripheral vasoconstrictor action.
Renal, coronary, and cerebral blood flow are a function of perfusion pressure and regional resistance. In most instances of cardiogenic shock, the beneficial effect of sympathomimetic amines is attributable to their positive inotropic effect. In patients with insufficient or failing vasoconstriction, there is additional advantage to the peripheral action of metaraminol, but in most patients with shock, vasoconstriction is adequate, and any further increase is unnecessary. Therefore, blood flow to vital organs may decrease with metaraminol if regional resistance increases excessively.
The pressor effect of metaraminol is decreased but not reversed by alpha-adrenergic blocking agents. A primary or secondary fall in blood pressure and a tachyphylactic response to repeated use are uncommon.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each mL of injection also contains sodium chloride 4.7 mg, citric acid monohydrate 0.1 mg, glacial acetic acid 1 mg, sodium acetate trihydrate 0.5 mg, disodium edetate 0.5 mg in water for injections to 1 mL.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
See Section 4.2 for Compatibility information.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Supplied in packs of 5 x 1 mL yellow glass ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: (1R,2S)-2-amino-1-(3-hydroxyphenyl)propan-1-ol hydrogen (2R,3R)- tartrate.
Molecular formula: C9H13NO2.C4H6O6.

CAS number.

33402-03-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes