SUMMARY CMI

Ephedrine Hydrochloride 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 Ephedrine Hydrochloride Juno?

Ephedrine Hydrochloride Juno contains the active ingredient ephedrine hydrochloride. Ephedrine Hydrochloride Juno is used to treat the low blood pressure which may occur during spinal anaesthesia. It works by contracting the blood vessels in your limbs, so that more blood is available for your heart.

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

2. What should I know before I use Ephedrine Hydrochloride Juno?

Do not use if you have ever had an allergic reaction to ephedrine hydrochloride 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 Ephedrine Hydrochloride Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ephedrine Hydrochloride 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 Ephedrine Hydrochloride Juno?

• Ephedrine Hydrochloride Juno must only be given by a doctor or nurse.
• Ephedrine Hydrochloride Juno is administered as a slow injection into the vein.
• Your doctor will decide what dose of Ephedrine Hydrochloride Juno you will receive. 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 Ephedrine Hydrochloride Juno? in the full CMI.

5. What should I know while using Ephedrine Hydrochloride Juno?

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

6. Are there any side effects?

Possible side effects include headache, dry nose, mouth or throat, fever or sweating, nausea, vomiting or stomach pain, mood or mental changes, such as nervousness, anxiety or irritability, difficult or painful urination, chest pain, breathing difficulty, irregular, fast or slow heartbeat.

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

Ephedrine Hydrochloride Juno

Active ingredient(s): Ephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ephedrine Hydrochloride 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 Ephedrine Hydrochloride Juno.

Where to find information in this leaflet:

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

1. Why am I using Ephedrine Hydrochloride Juno?

Ephedrine Hydrochloride Juno contains the active ingredient ephedrine hydrochloride.

Ephedrine Hydrochloride Juno is used to treat the low blood pressure which may occur during spinal anaesthesia. It works by contracting the blood vessels in your limbs, so that more blood is available for your heart.

2. What should I know before I use Ephedrine Hydrochloride Juno?

Warnings

Do not use Ephedrine Hydrochloride Juno if:

• you are allergic to ephedrine hydrochloride, 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 have, or have had any of the following medical conditions:
  - heart problems
  - pheochromocytoma (a rare tumour of the adrenal gland near the kidney)
  - closed angle glaucoma (a condition in which there is a build up of pressure in the eye)
  - mood/thought disorders and were given monoamine oxidase (MAO) inhibitors in last two weeks or about to commence on this group of medicines
• using an antibiotic medicine called linezolid
• undergoing general anaesthesia
• the packaging is torn or shows signs of tampering
• the expiry date on the pack has passed.
  If you are given this medicine after the expiry date has passed, it may not work as well or it may make you feel sick.

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.

Your doctor will discuss the risks and benefits of using Ephedrine Hydrochloride Juno.

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

Ephedrine Hydrochloride Juno is not recommended for use if you are breastfeeding.

Children

Ephedrine Hydrochloride Juno is not approved for use in children.

Tell your doctor any of the following before you are given Ephedrine Hydrochloride Juno:

If you have or have ever had any other health problems other medical conditions, including:

• high or low blood pressure
• prostrate problems or difficulty in passing urine
• mental health disorders
• thyroid problems
• diabetes.

If you are an athlete or competing in sports

Ephedrine Hydrochloride Juno contains an active substance that may cause a positive reaction in anti-doping tests.

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 Ephedrine Hydrochloride Juno and affect how it works. You may need different amounts of your medicine, or you may need to take different medicines.

These include:

• Medicines used to treat heart failure (e.g. digoxin)
• Alpha blockers (e.g. prazosin and methyldopa) or beta blockers (e.g. propranolol) used to treat high blood pressure
• Medicines used to treat mental health disorders such as amitriptyline, moclobemide, phenelzine, venlafaxine and dothiepin
• Medicines used in the treatment of migraine such as ergotamine and any derivatives
• Theophylline (a medicine used to treat asthma)
• Acetazolamide, dichlorphenamide, sodium bicarbonate, sodium citrate (medicines that make urine less acidic)
• Linezolid (an antibiotic)
• Medicines used to treat epilepsy such as phenytoin
• Medicines used to treat ADHD such as methylphenidate
• Medicines found commonly in over the counter cold and flu preparations such as pseudoephedrine and phenylephrine.

Your doctor has more information on medicines to be careful with or avoid while being given Ephedrine Hydrochloride Juno.

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

4. How do I use Ephedrine Hydrochloride Juno?

Ephedrine Hydrochloride Juno must only be given by a doctor or nurse.

How much Ephedrine Hydrochloride Juno is given

Your doctor will decide what dose of Ephedrine Hydrochloride Juno you will receive. This depends on your medical condition and other factors, such as your weight. Sometimes only a single dose of is required.

How Ephedrine Hydrochloride Juno is given

Ephedrine Hydrochloride Juno is administered as a slow injection into a vein.

If you use too much Ephedrine Hydrochloride Juno

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

If you think that you have being given too much Ephedrine Hydrochloride Juno, you may need urgent medical attention.

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 Ephedrine Hydrochloride Juno?

Things you should do

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

Driving or using machines

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Ephedrine Hydrochloride Juno will be stored in the pharmacy or on the ward.

Ephedrine Hydrochloride Juno pre-filled syringe injection is kept in a cool dry place where the temperature stays below 30°C.

Ephedrine Hydrochloride Juno ampoule injection is kept in a cool dry place where the temperature stays below 25°C.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Ephedrine Hydrochloride 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 Ephedrine Hydrochloride Juno contains

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

What Ephedrine Hydrochloride Juno looks like

Ephedrine Hydrochloride Juno is a clear and colourless solution, containing 30 mg/10 mL ephedrine hydrochloride.

Ephedrine Hydrochloride Juno is supplied in either polypropylene syringes or polypropylene ampoules, available in pack sizes of 10.

30 mg/10 mL ampoule: AUST R 285492

30 mg/10 mL prefilled syringe: AUST R 285489

Who distributes Ephedrine Hydrochloride Juno

Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street,
Cremorne,
VIC 3121 Australia.
www.junopharm.com.au

This leaflet was prepared in October 2024.

Published by MIMS December 2024

1 Name of Medicine

Ephedrine Hydrochloride Juno contains ephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Ephedrine Hydrochloride Juno is a sterile solution of ephedrine hydrochloride in water for injections. Each 10 mL contains 30 mg of ephedrine hydrochloride (equivalent to 24.6 mg ephedrine), sodium chloride, citric acid monohydrate, and sodium citrate in Water for Injections. The pH is 4.0-5.5.
Ephedrine Hydrochloride Juno contains no preservative and is for single use in one patient on one occasion only. Discard any remaining residue.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ephedrine hydrochloride 30 mg/10 mL solution for injection polypropylene ampoule.
Ephedrine hydrochloride 30 mg/10 mL solution for injection polypropylene syringe.

4 Clinical Particulars

4.1 Therapeutic Indications

Ephedrine Hydrochloride Juno is indicated in the treatment of hypotension secondary to spinal anaesthesia.

4.2 Dose and Method of Administration

Ephedrine Hydrochloride Juno is not approved for use in children (see Section 4.4 Special Warnings and Precautions for Use).
The injection should be given slowly. Care should be taken to avoid extravasation, since this may result in tissue necrosis and sloughing. Ephedrine hydrochloride should be administered in the lowest effective dose.
The injection should be given as a slow intravenous injection of 3 to 7.5 mg (maximum 10 mg), repeated as needed every 3-4 min to a maximum of 30 mg.
A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent.
During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient's normal blood pressure. In previously normotensive patients, systolic blood pressure should be maintained at 80 to 100 mmHg. In previously hypertensive patients, systolic blood pressure should be maintained at 30 to 40 mmHg below their usual blood pressure. In some patients with very severe hypotension, maintenance of even lower blood pressure may be desirable if blood or fluid volume replacement has not been completed.

Compatibilities.

4.3 Contraindications

Ephedrine is contraindicated in closed angle glaucoma, since ephedrine may exacerbate the condition.
Ephedrine is contraindicated in patients with pheochromocytoma, since severe hypertension may result.
Ephedrine is contraindicated in patients with asymmetric septal hypertrophy (idiopathic hypertrophic subaortic stenosis) since the obstruction may increase as myocardial contractility improves.
Ephedrine is contraindicated in patients undergoing therapy with monoamine oxidase inhibitors (MAO inhibitors), or within 14 days of ceasing such therapy, since MAO inhibitors may prolong and intensify the cardiac and pressor effects of ephedrine.
Ephedrine is contraindicated in patients using linezolid.
Ephedrine is contraindicated in patients undergoing general anaesthesia with cyclopropane or halothane or other halogenated hydrocarbons, since anaesthesia may increase cardiac irritability which may lead to arrhythmias.
Ephedrine is contraindicated in patients with tachyarrhythmias or ventricular fibrillation, since exacerbation of these conditions may occur.
Ephedrine is also contraindicated in patients with hypersensitivity to ephedrine and in patients with psychoneurosis.

4.4 Special Warnings and Precautions for Use

The use of ephedrine as a pressor agent is not a substitute for replacement of blood, plasma, fluids and/or electrolytes. Blood volume depletion should be corrected as fully as possible before ephedrine therapy is instituted. In an emergency, ephedrine may be used as an adjunct to fluid volume replacement or as a temporary supportive measure to maintain coronary and cerebral artery perfusion until volume replacement therapy can be completed, but ephedrine must not be used as sole therapy in hypovolaemic patients.
Ephedrine may deplete noradrenaline stores in sympathetic nerve endings resulting in reduced cardiac and pressor effects of the drug. Consequently, it may be necessary to administer noradrenaline to replace tissue stores for restoration of the pressor effects of ephedrine.
Caution should be exercised if a dose greater than the maximum recommended bolus is administered as this may lead to undesirable hypertension.
Prolonged administration of pressor agents has been associated with oedema, haemorrhage, focal myocarditis, subpericardial haemorrhage, necrosis of the intestine and hepatic and renal necrosis. Since these effects have generally been observed in patients with severe shock and it is not clear if the drug or the shock state itself was responsible, they should therefore be taken into consideration before ephedrine is used.
Hypoxia, hypercapnia and acidosis may also reduce the effectiveness or increase the incidence of adverse effects of ephedrine, and should be identified and corrected prior to or concurrently with administration of the drug.
Ephedrine should be used with caution, if at all, in patients with hypertension or hyperthyroidism, since there is an increased risk of adverse effects in these patients.
Ephedrine should also be used with caution in patients with cardiovascular disease including angina, cardiac arrhythmia and coronary insufficiency, since the cardiovascular effects of ephedrine may exacerbate these conditions. Ephedrine may intensify the ischaemia in myocardial infarction by increasing myocardial oxygen demands.
Ephedrine should also be used with caution in geriatric males, especially those with prostatic hypertrophy, since ephedrine may cause acute urinary retention.
Ephedrine should also be used with caution in diabetic patients since drug induced hyperglycaemia may result in loss of diabetic control.

Athletes.

Patient monitoring.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alpha blockers.

Atropine sulfate.

Beta blockers.

Cardiac glycosides.

Ergotamine, ergometrine, methylergometrine, oxytocin.

Guanethidine.

Hydrocarbon inhalation anaesthetics, such as cyclopropane, halothane.

Methyldopa.

Monoamine oxidase (MAO) inhibitors.

Reserpine.

Sympathomimetic agents.

Tricyclic antidepressants.

Clonidine.

Urinary alkalinisers, such as acetazolamide, dichlorphenamide, sodium bicarbonate and sodium citrate.

Theophylline.

Indirect sympathomimetic agents (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate).

Ergot alkaloids (dopaminergic action).

Noradrenergic-serotoninergic antidepressants (minalcipran, venlafaxine).

Sibutramine.

Antiepileptics.

Doxapram.

Moclobemide.

Linezolid.

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)

Body as a whole.

Cardiovascular system.

Vascular disorder.

Gastrointestinal system.

Nervous system.

Renal and urinary system.

Respiratory system.

Skin and appendages.

Blood and lymphatic system disorders.

Immune system disorders.

Psychiatric disorders.

Eye disorders.

Investigations.

Reporting suspected adverse effects.

4.9 Overdose

Due to the rapid onset, but short duration of the drug, it is rarely necessary to actively manage adverse effects, as they tend to be of short duration and self-limiting.

Clinical features.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agent.
ATC code: C01CA26.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Pharmacokinetic data for ephedrine following intravenous administration is limited. After intravenous administration, ephedrine is completely bioavailable and clinical effects occur within 3-5 minutes; these persist for 10-15 minutes before heart rate begins to decrease.
Approximately 90% of an intravenous dose is excreted in the urine in 24 hours although, as an alkaloid, its excretion rate is reduced in alkaline urine. After intravenous administration, the majority of ephedrine is excreted unchanged in the urine, although this varies depending on urine pH. The major metabolite is the N-demethylated and biologically active norephedrine (up to 20%) with smaller amounts of other deaminated metabolites also reported. The elimination half-life of ephedrine is urinary pH dependent and has been reported to be from 3-7 hours, with faster excretion expected in acidic urine.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, citric acid monohydrate, sodium citrate, sodium hydroxide, hydrochloric acid, water for injections.

6.2 Incompatibilities

Ephedrine is reported to be physically incompatible with the phenobarbitone sodium, pentobarbitone sodium, quinalbarbitone sodium and thiopentone sodium, and with hydrocortisone sodium succinate in some infusion solutions.

6.3 Shelf Life

3 years.
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

For the ampoule: Store below 25°C.
For the pre-filled syringe: Store below 30°C and store the blister in the outer carton, protected from light.

6.5 Nature and Contents of Container

Ephedrine Hydrochloride Juno is a clear and colourless solution, containing 30 mg/10 mL ephedrine hydrochloride.
Ephedrine Hydrochloride Juno is supplied in either polypropylene syringes or polypropylene ampoules.
Pack size: 10.

6.6 Special Precautions for Disposal

Ephedrine Hydrochloride Juno contains no preservative and is for single use in one patient on one occasion only. Discard any remaining residue.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Ephedrine hydrochloride.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes