Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Ephedrine Hydrochloride Aguettant. It does not contain all the available information.

It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ephedrine Hydrochloride Aguettant against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor.

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

What Ephedrine Hydrochloride Aguettant Injection is used for

Ephedrine Hydrochloride Aguettant 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.

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 Hydrochloride Aguettant is available only with a doctor’s prescription.

Ephedrine Hydrochloride Aguettant is not approved for use in children.

Before you are given Ephedrine Hydrochloride Aguettant Injection

When you must not be given it

You should not be given Ephedrine Hydrochloride Aguettant if:

• you have an allergy to ephedrine 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:
  - 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.

Before you are given it

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

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

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

2. if you are pregnant or intend to become pregnant

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

3. if you are breast-feeding or plan to breast-feed

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

4. if you are an athlete or competing in sports

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

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with Ephedrine Hydrochloride Aguettant.

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.

These medicines may be affected by Ephedrine Hydrochloride Aguettant, 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 has more information on medicines to be careful with or avoid while being given Ephedrine Hydrochloride Aguettant.

If you are not sure whether you should be given Ephedrine Hydrochloride Aguettant, talk to your doctor.

How Ephedrine Hydrochloride Aguettant Injection is given

How much is given

Ephedrine Hydrochloride Aguettant is administered as a slow injection into a vein

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

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

If you take too much (overdose)

As Ephedrine Hydrochloride Aguettant 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 (Australia on 131 126) 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 Hydrochloride Aguettant.

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.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are having Ephedrine Hydrochloride Aguettant.

Ephedrine Hydrochloride Aguettant may have unwanted side-effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side-effects.

Ask your doctor to answer any questions you may have.

While being given it

Tell your doctor or nurse immediately if you notice any of the following:

• 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 difficulties
• irregular, fast or slow heartbeat

Some people may get other side effects while being given Ephedrine Hydrochloride Aguettant.

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

After having Ephedrine Hydrochloride Aguettant Injection

Storage

Ephedrine Hydrochloride Aguettant will be stored in the pharmacy or on the ward. Ephedrine Hydrochloride Aguettant pre-filled syringe injection is kept in a cool dry place where the temperature stays below 30°C. Ephedrine Hydrochloride Aguettant ampoule injection is kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

Ephedrine Hydrochloride Aguettant is a clear and colourless solution. Ephedrine Hydrochloride Aguettant is available in the followings strength and pack size: 30 mg/10 mL strength in a pre-filled syringe or amouple in pack sizes of 10.

Ingredients

The active ingredient in Ephedrine Hydrochloride Aguettant is ephedrine hydrochloride.

Each ampoule contains 3 mg/mL of ephedrine hydrochloride.

Excipients

Ephedrine Hydrochloride Aguettant also contains the following excipients:

Sodium chloride
Citric acid monohydrate
Sodium citrate
Sodium hydroxide
Hydrochloric acid
Water for injections.

Ephedrine Hydrochloride Aguettant does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

Juno Pharmaceuticals Pty Ltd
42 Kelso Street, Cremorne
VIC 3121, Australia
medical-enquiries@junopharm.com.au

Australian Registration Number

30 mg/10 mL pre-filled syringe: AUST R 285489

30 mg/10 mL ampoule: AUST R 285492

This leaflet was prepared in August 2021.

Published by MIMS October 2021

1 Name of Medicine

Ephedrine Hydrochloride Aguettant contains ephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Ephedrine Hydrochloride Aguettant 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 Aguettant 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

4.9 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. Symptoms associated with overdosage of ephedrine include headache, severe nausea or vomiting, chills or fever, dizziness or lightheadedness, anxiety, nervousness, restlessness, mood changes, convulsions, severe weakness, blurred vision or enlarged pupils, ongoing fast heartbeat, severe or ongoing chest pain, severe hypertension or hypotension, and severe breathing difficulties.
Paranoid psychosis, delusions and hallucinations may also follow ephedrine overdosage.
Treatment. Treatment of overdose involves the following measures:
reduce dosage or discontinue administration of ephedrine;
general supportive therapy, including monitoring and maintaining vital signs, blood gases, electrolytes and ECG.
The following additional measures may need to be considered:
beta blockers to control tachycardia and arrhythmia;
nitroprusside to reduce severe hypertension;
diazepam to control convulsions. General anaesthesia and neuromuscular blocking agents may need to be considered to treat refractory seizures;
dexamethasone to treat pyrexia.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ephedrine sulfate was not mutagenic in four strains of Salmonella typhimurium (TA100, TA1535, TA97, or TA98) with or without Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver S9 activation. Ephedrine sulfate did not induce sister-chromatid exchanges or chromosomal aberrations in cultured Chinese hamster ovary cells.
Carcinogenicity. Carcinogenesis studies of ephedrine were conducted by administering 0, 125, or 250 ppm of ephedrine sulfate to groups of rats and mice for 103 weeks. Neoplasms that occurred in these studies were not considered to be related to administration of the drug. Two high dose female mice had ovarian granulose cell tumours, and luteomas were found in one low dose and one high dose female mouse. Because of the low incidence, these uncommon, benign tumours could not be clearly related to ephedrine sulfate administration.
Under the conditions of these studies, there was no evidence of carcinogenicity for rats or mice of either sex receiving 125 or 250 ppm ephedrine sulfate in the diet for 2 years.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ephedrine hydrochloride.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSEPHHCL.gif Chemical name: (1R,2S)-2-(methylamino)-1-phenylpropan-1-ol hydrochloride).
Molecular formula: C₁₀H₁₅NO.HCl.
CAS number. [50-98-6].
Molecular weight: 201.7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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