SUMMARY CMI

EPHEDRINE-HAMELN INJECTION

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 being given Ephedrine-hameln?

Ephedrine-hameln contains the active ingredient ephedrine hydrochloride. Ephedrine-hameln is used to treat low blood pressure which may occur during spinal anaesthesia.

For more information, see Section 1. Why am I being given Ephedrine-hameln? in the full CMI.

2. What should I know before I am given Ephedrine-hameln?

Do not use Ephedrine-hameln 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 am given Ephedrine-hameln? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ephedrine-hameln 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 will I be given Ephedrine-hameln?

• Ephedrine-hameln is given as a slow injection into a vein; it must only be given by a doctor or nurse.
• Your doctor will decide what dose of Ephedrine-hameln you will be given and how long it will be given for.

More instructions can be found in Section 4. How will I be given Ephedrine-hameln? in the full CMI.

5. What should I know while being given Ephedrine-hameln?

For more information, see Section 5. What should I know while being given Ephedrine-hameln? in the full CMI.

6. Are there any side effects?

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-HAMELN INJECTION

Active ingredient(s): ephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ephedrine-hameln. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Ephedrine-hameln.

Where to find information in this leaflet:

1. Why am I being given Ephedrine-hameln?
2. What should I know before I am given Ephedrine-hameln?
3. What if I am taking other medicines?
4. How will I be given Ephedrine-hameln?
5. What should I know while being given Ephedrine-hameln?
6. Are there any side effects?
7. Product details

1. Why am I being given Ephedrine-hameln?

Ephedrine-hameln contains the active ingredient ephedrine hydrochloride. It works by contracting the blood vessels in your limbs, so that more blood is available for your heart.

EP-hameln is used to treat the low blood pressure which may occur during spinal anaesthesia.

Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you.

Ephedrine-hameln is available only with a doctor's prescription.

Ephedrine-hameln is not approved for use in children.

2. What should I know before I am given Ephedrine-hameln?

Warnings

Do not use Ephedrine-hameln if:

• you are allergic to ephedrine hydrochloride, or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction to ephedrine may include:
  - Shortness of breath, wheezing or difficulty in breathing
  - swelling of the face, lips, tongue or other parts of the body
  - rash, itching or hives on the skin.
• you have, or have had any of the following medical conditions:
  - some heart problem such as ventricular fibrillation, tachyarrhythmias, coronary thrombosis and idiopathic hypertrophic subaortic stenosis)
  - 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
• using an antibiotic called linezolid
• using general anaesthetic such as cyclopropane or halothane
• using or have had use an antidepressant called monoamine oxidase inhibitors (MAO inhibitors) such as phenelzine or moclobemide within the last 14 days
• 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

Check with your doctor:

1. if you have or have ever had any other health problems or medical conditions, including:

• high or low blood pressure
• prostate problems or difficulty in passing urine
• mental health problems
• thyroid problems
• diabetes
• heart problems such as angina (chest pain) and cardiac arrhythmia (irregular heart rate)
  Your doctor may need to carefully monitor you.

2. if you are an athlete or competing in sport

Ephedrine-hameln contains an active substance that may cause a positive reaction in antidoping tests.

If you have not told your doctor about any of the above, tell them before you are given Ephedrine-hameln.

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

Your doctor will discuss the risks and benefits of using Ephedrine-hameln during pregnancy.

Your doctor will discuss the risks and benefits of using Ephedrine-hameln when breast-feeding. Ephedrine-hameln is not recommended for use if you are breastfeeding.

3. What if I am taking other medicines?

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

Some medicines may interfere with Ephedrine-hameln. These include:

• Medicines used to treat heart failure (e.g. digoxin).
• Alpha blockers or beta blockers (used to treat high blood pressure, e.g. prazosin, propranolol or methyldopa)
• Medicines used to manage depression or mental health disorders such as monoamine oxidase (MAO) inhibitors (e.g. phenelzine or moclobemide), tricyclic antidepressants (e.g. dothiepin or amitriptyline) and noradrenergic - serotoninergic antidepressants (e.g. venlafaxine, milnacipran)
• Medicines used in the treatment of migraine such as ergotamine and derivatives
• Reserpine (used in the treatment of blood pressure or mental disorders)
• Guanethidine used to lower blood pressure
• Theophylline (a medicine used to treat asthma)
• Acetazolamide, dichlorphenamide, sodium bicarbonate, sodium citrate (medicines that make urine less acidic i.e. alkaline)
• 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
• Atropine (medicine used in heart problems or bowel problems)
• Medicine used in general anaesthetics such as cyclopropane and halothane
• Clonidine (medicine used to treat high blood pressure)
• Dexamethasone, a corticosteroid
• Sibutramine, an appetite suppressant
• Doxapram, a medicine that assists with breathing

These medicines may be affected by Ephedrine-hameln, or may affect how well it works.

You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while being given Ephedrine-hameln.

If you are not sure whether you should be given ephedrine, talk to your doctor or pharmacist.

4. How will I be given Ephedrine-hameln?

Ephedrine-hameln is given as a slow injection into a vein. Ephedrine-hameln must only be given by a doctor or nurse.

How much will be given

• Your doctor will decide what dose of Ephedrine-hameln you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight.
• Sometimes only a single dose of is required.

If you are given too much Ephedrine-hameln

As Ephedrine-hameln is given to you under the supervision of a doctor, it is unlikely that you will receive an overdose. However, if you experience severe side effects tell your doctor immediately.

Immediately telephone your doctor or the Poisons Information Centre (In Australia, call 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ephedrine-hameln.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose include the side effects listed in the “Side Effects” section (see below) but are usually of a more severe nature. They include severe nausea or vomiting, severe high or low blood pressure, severe breathing difficulties, dizziness or lightheadedness and convulsion.

5. What should I know while being given Ephedrine-hameln?

Things you should do

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Ephedrine-hameln.

Remind any doctor, dentist or pharmacist you visit that you have been given Ephedrine-hameln.

Driving or using machines

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

Drinking alcohol

Tell your doctor if you drink alcohol.

How your medicine will be stored

Ephedrine-hameln will be stored in the pharmacy or on the ward.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any Ephedrine-hameln that may be left over.

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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

While being given Ephedrine-hameln

Tell your doctor or nurse 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.

7. Product details

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

What Ephedrine-hameln contains

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

What Ephedrine-hameln looks like

Ephedrine-hameln is a clear, colourless solution

Who distributes Ephedrine-hameln

Ephedrine-hameln is supplied by:

hameln pharma Pty Ltd
Level 3, 302 Burwood Rd,
Hawthorn, Victoria 3122,
Australia
[email protected]

Australian Registration Numbers

30 mg/1 mL: AUST R 337996

Date of Preparation

This leaflet was prepared on 06 November 2024

Published by MIMS July 2025

1 Name of Medicine

Ephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Ephedrine-hameln is a colourless, clear solution containing the active ingredient ephedrine hydrochloride. Ephedrine-hameln comes in one strength containing 30 mg/1 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ephedrine hydrochloride is a white to almost white crystalline powder or colourless crystals. Ephedrine-hameln is a sterile solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Ephedrine-hameln is indicated in the treatment of hypotension secondary to spinal anaesthesia.

4.2 Dose and Method of Administration

Ephedrine-hameln is not approved for use in children (see Section 4.4 Special Warnings and Precautions for Use).
Ephedrine-hameln must be diluted prior to administration.
Ephedrine-hameln is administered by the intravenous route. 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 parenteral adult dose should not exceed 150 mg in 24 hours.
A lack of efficacy after 30 mg should lead to reconsideration of the choice of the therapeutic agent.
Product is for single use in one patient only. Discard any residue.

As a pressor.

Adult dose.

Patients with renal or hepatic impairment.

Compatibilities.

Incompatibilities.

4.3 Contraindications

Ephedrine-hameln is contraindicated in:
closed angle glaucoma, since ephedrine may exacerbate the condition;
patients with pheochromocytoma, since severe hypertension may result;
patients with asymmetric septal hypertrophy (idiopathic hypertrophic subaortic stenosis) since the obstruction may increase as myocardial contractility improves;
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;
patients undergoing general anaesthesia with cyclopropane or halothane or other halogenated hydrocarbons, since anaesthesia may increase cardiac irritability which may lead to arrhythmias;
patients with tachyarrhythmias, coronary thrombosis or ventricular fibrillation, since exacerbation of these conditions may occur;
patients with hypersensitivity to ephedrine and in patients with psychoneurosis;
patients using linezolid.

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 hydrochloride 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-hameln 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-hameln should also be used with caution in:
geriatric males, especially those with prostatic hypertrophy, since ephedrine may cause acute urinary retention;
diabetic patients since drug induced hyperglycaemia may result in loss of diabetic control;
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.

Athletes.

Patient monitoring.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alpha blockers.

Atropine sulphate.

Beta blockers.

Cardiac glycosides.

Ergotamine, ergometrine, methylergometrine, oxytocin.

Guanethidine.

Hydrocarbon inhalation anaesthetics, such as cyclopropane, halothane.

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

Methyldopa.

Moclobemide.

Monoamine oxidase (MAO) inhibitors.

Noradrenergic-serotoninergic antidepressants (milnacipran, venlafaxine).

Linezolid.

Reserpine.

Sympathomimetic agents.

Tricyclic antidepressants.

Clonidine.

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

Theophylline.

Corticosteroids.

Antiepileptics.

Ergot alkaloids (dopaminergic action).

Sibutramine.

Doxapram.

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)

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.

Body as a whole.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Cardiovascular system disorders.

Vascular disorders.

Respiratory system.

Gastrointestinal disorders.

Renal and urinary disorders.

Skin and appendages.

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

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The duration of pressor and cardiac responses to ephedrine is 1 hour after intravenous administration of 10 to 25 mg. Small quantities of ephedrine are metabolised in the liver, but the majority of ephedrine is excreted unchanged in the urine. The plasma half-life of ephedrine is 3 to 6 hours. Elimination of ephedrine is increased (and hence the half-life is decreased) with decreasing pH of the urine. Ephedrine is presumed to cross the placenta, and to be excreted into breast milk.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ephedrine-hameln contains the inactive ingredient 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.

6.5 Nature and Contents of Container

Solution for injection, 30 mg/mL ephedrine hydrochloride: Type I clear glass ampoule containing 1 mL of solution. Packs of 5 or 10 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.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).