SUMMARY CMI

Metaraminol Juno

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Metaraminol Juno?

Metaraminol Juno contains the active ingredient metaraminol tartrate. Metaraminol Juno is used to increase your blood pressure which can drop during spinal anaesthesia or can drop as a reaction to medications or surgical complications.

For more information, see Section 1. Why am I using Metaraminol Juno? in the full CMI.

2. What should I know before I use Metaraminol Juno?

Do not use if you have ever had an allergic reaction to Metaraminol Juno or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Metaraminol Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Metaraminol Juno and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Metaraminol Juno?

• Metaraminol Juno must only be given by a doctor or nurse.
• Metaraminol Juno is administered in a hospital as an injection into a vein or diluted before use and given with fluids into a vein.
• Your doctor will decide what dose of Metaraminol Juno you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight.

More instructions can be found in Section 4. How do I use Metaraminol Juno? in the full CMI.

5. What should I know while using Metaraminol Juno?

For more information, see Section 5. What should I know while using Metaraminol Juno? in the full CMI.

6. Are there any side effects?

Possible side effects include fast or pounding heartbeat, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, and breathlessness or any difficulty breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Metaraminol Juno

Active ingredient(s): Metaraminol (as tartrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Metaraminol Juno. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Metaraminol Juno.

Where to find information in this leaflet:

1. Why am I using Metaraminol Juno?
2. What should I know before I use Metaraminol Juno?
3. What if I am taking other medicines?
4. How do I use Metaraminol Juno?
5. What should I know while using Metaraminol Juno?
6. Are there any side effects?
7. Product details

1. Why am I using Metaraminol Juno?

Metaraminol Juno contains the active ingredient metaraminol tartrate. Metaraminol Juno is a sympathomimetic amine. It strengthens the contraction of the heart muscle and constricts blood vessels to help increase the blood pressure.

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

2. What should I know before I use Metaraminol Juno?

Warnings

Do not use Metaraminol Juno if:

• you are allergic to metaraminol tartrate, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• you are being given cyclopropane or halothane anaesthesia (unless clinical circumstances demand their use).
• the solution is discoloured, cloudy, turbid, or a precipitate is present.

Check with your doctor if you:

• have any other medical conditions
  - liver disease
  - heart or thyroid disease
  - high blood pressure
  - diabetes
  - malaria
• have allergies to any other medicines or any other substances including foods, preservatives or dyes.
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children

• Metaraminol Juno is not recommended for use in children.

3. What if I am taking other medicines?

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

Some medicines may interfere with Metaraminol Juno and affect how it works.

• 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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Metaraminol Juno.

4. How do I use Metaraminol Juno?

Metaraminol Juno must only be given by a doctor or nurse.

How much Metaraminol Juno is given

Your doctor will decide what dose of Metaraminol Juno you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight.

How Metaraminol Juno is given

• Metaraminol Juno is administered in a hospital as an injection into a vein or diluted before use and given with fluids into a vein.

If you use too much Metaraminol Juno

As Metaraminol Juno is always given to you in a hospital under the supervision of a doctor, it is unlikely that you will receive an overdose.

However, you should tell your doctor or nurse immediately if you feel unwell at all whilst you are being given Metaraminol Juno. You may need urgent medical attention.

Symptoms of an overdose may include:

• nausea and/or vomiting
• excessive sweating
• breathlessness
• tightness or pain in the chest
• fast or slow heart beat
• feeling of happiness
• convulsions, fits or seizures

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Metaraminol Juno?

Things you should do

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

Remind any doctor, dentist or pharmacist you visit that you are using Metaraminol Juno.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Metaraminol Juno affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Metaraminol Juno 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 Juno must be stored below 25°C, protected from light. Do not freeze.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Metaraminol Juno should only be given to you in a hospital therefore the doctor or nurse will dispose of any left over.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Metaraminol Juno contains

Do not take this medicine if you are allergic to any of these ingredients.

What Metaraminol Juno looks like

Metaraminol Juno is a clear colourless sterile solution of metaraminol tartrate equivalent to 0.5 mg/mL metaraminol in a sterile polypropylene pre-filled syringe of 5 or 10 mL, ready-to-use, packaged in a blister pack.

2.5 mg/5 mL presentation: AUST R 298220

5 mg/10 mL presentation: AUST R 298219

Who distributes Metaraminol Juno

Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne,
VIC 3121

www.junopharm.com.au

This leaflet was prepared in August 2024

Published by MIMS October 2024

1 Name of Medicine

Metaraminol tartrate.

2 Qualitative and Quantitative Composition

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.
Each mL of Metaraminol Juno solution for injection contains metaraminol (as tartrate) 0.5 mg, sodium chloride 9 mg, hydrochloric acid and water for injections to 1 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Metaraminol (as tartrate) 5 mg/10 mL injection pre-filled syringe.
Metaraminol (as tartrate) 2.5 mg/5 mL injection pre-filled syringe.

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 Juno injection is for intravenous administration only (injection) and should be used in one patient on one occasion only.
It contains no antimicrobial preservative. Unused solution should be discarded.
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.

Direct intravenous injection.

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 peripheral vascular disease, diabetes mellitus, Buerger's disease, or conditions with coexistent hypercoagulability.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Metaraminol Juno injection should be used with caution in digitalised patients, since the combination of digitalis and sympathomimetic amines is capable of causing ectopic arrhythmic activity.
MAOIs and tricyclic antidepressants have been reported to potentiate the action of sympathomimetic amines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 and anaphylactic reaction 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 effects.

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 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, hydrochloric acid, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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 and protect from light. Do not freeze.

6.5 Nature and Contents of Container

A clear colourless sterile solution of metaraminol tartrate equivalent to 0.5 mg/mL metaraminol in a sterile polypropylene pre-filled syringe of 5 or 10 mL, ready-to-use, packaged in a blister pack.
2.5 mg/5 mL presentation: AUST R 298220.
5 mg/10 mL presentation: AUST R 298219.

Pack size.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes