Consumer medicine information

EPHEDRINE HYDROCHLORIDE MYX

Ephedrine hydrochloride

BRAND INFORMATION

Brand name

Ephedrine Hydrochloride MYX Solution for injection

Active ingredient

Ephedrine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using EPHEDRINE HYDROCHLORIDE MYX.

What is in this leaflet

This leaflet answers some common questions about Ephedrine Hydrochloride MYX. 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 MYX 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 MYX Injection is used for

Ephedrine Hydrochloride MYX 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 MYX is available only with a doctor’s prescription.

Ephedrine Hydrochloride MYX is not approved for use in children.

Before you are given Ephedrine Hydrochloride MYX Injection

When you must not given it

You should not be given Ephedrine Hydrochloride MYX 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 MYX:

  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
  1. if you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of using Ephedrine Hydrochloride MYX.
  2. if you are breast-feeding or plan to breast-feed
    Ephedrine Hydrochloride MYX is not recommended for use if you are breastfeeding.
  3. if you are an athlete or competing in sports
    Ephedrine Hydrochloride MYX 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 MYX.

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 MYX. 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 MYX, 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 MYX.

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

How Ephedrine Hydrochloride MYX Injection is given

How much is given

Ephedrine Hydrochloride MYX is diluted with saline 0.9% and administered as an slow injection into a vein

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

Your doctor will decide what dose of Ephedrine Hydrochloride MYX 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 MYX is given to you under the supervision of an 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 (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 Hydrochloride MYX. 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 MYX.

Ephedrine Hydrochloride MYX 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 MYX.

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

After having Ephedrine Hydrochloride MYX Injection

Storage

Ephedrine Hydrochloride MYX will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25ºC, and it is protected from light.

Product description

What it looks like

Ephedrine Hydrochloride MYX is a clear and colourless solution.

Ephedrine Hydrochloride MYX is available in the followings strength and pack size: 25 mg/1 mL strength, 5 glass yellow ampoules per pack.

Ingredients

The active ingredient in Ephedrine Hydrochloride MYX is ephedrine hydrochloride.

Each ampoule contains 25 mg/mL of ephedrine hydrochloride.

Ephedrine Hydrochloride MYX also contains water for injections.

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

Supplier

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

Australian Registration Number
25 mg/1 mL: AUST R 243672

This leaflet was prepared in July 2016.

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

BRAND INFORMATION

Brand name

Ephedrine Hydrochloride MYX Solution for injection

Active ingredient

Ephedrine hydrochloride

Schedule

S4

 

1 Name of Medicine

Ephedrine hydrochloride.

6.7 Physicochemical Properties

Chemical structure.


The molecular formula of ephedrine hydrochloride is C10H15NO.HCl. Its molecular weight is 201.7.

CAS number.

The CAS registry number of ephedrine hydrochloride is 50-98-6.

2 Qualitative and Quantitative Composition

Ephedrine Hydrochloride MYX Injection is a sterile solution of ephedrine hydrochloride in water for injections. Each mL contains 25 mg of ephedrine hydrochloride (equivalent to 20.5 mg ephedrine) in water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ephedrine Hydrochloride MYX is a clear and colourless solution for injection.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ephedrine is a sympathomimetic which stimulates both alpha and beta adrenergic receptors, and also releases noradrenaline from its storage site. The main effects of therapeutic doses of ephedrine are relaxation of bronchial smooth muscle, cardiac stimulation and increased systolic and usually diastolic blood pressure via an increase in cardiac output and peripheral vasoconstriction. Ephedrine also decreases intestinal tone and motility, relaxes the bladder wall, contracts the sphincter muscle, relaxes the detrusor muscle, and decreases uterine activity. Ephedrine also has central nervous system stimulant effects. Tachyphylaxis to the effects of ephedrine may also occur after use for a short while possibly due to the depletion of noradrenaline stores.

Clinical trials.

The supporting evidence for the use of ephedrine in the treatment of hypotension secondary to spinal anaesthesia is based on published literature.
Several published randomised controlled and prospective studies examined the efficacy of ephedrine for the treatment and prophylaxis of hypotension with spinal anaesthesia administered via the intravenous route. The studies included women undergoing caesarian section, lower extremity or lower abdominal surgery, or ASA-I/ ASA-II patients. Patients were administered bolus dose in the range of 5 mg to 10 mg with the larger doses observed to provide greater efficacy. Most of the studies reported a dose titration using rescue IV ephedrine as a single bolus dose of around 2.5 mg to 10 mg, incremented as required when the systolic pressure or mean arterial pressure fell. On average, the studies reported patients required a total of 10 mg to 30 mg administered ephedrine dose. One of the dose response studies observed a greater incidence of reactive hypertension in patients given bolus doses of 30 mg ephedrine (45%) compared with those on the lower doses of 10 mg (5%) or 20 mg (25%) (p = 0.009). The efficacy varied between studies which may have been attributed to the administration of other drugs, prior fluid bolus, the level of the spinal block, the timing of the injection, the route and the dose of ephedrine used, and the study definition of hypotension. Overall, the body of literature evidence supports the use of ephedrine in the treatment of hypotension secondary to spinal anaesthesia administered via an IV bolus dose and with additional incremental rescue boluses as required to the effective dose.

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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

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

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 diabetic patients since drug induced hyperglycaemia may result in loss of diabetic control.
Athletes: warning, this product contains an active substance that may cause a positive reaction in anti-doping tests.

Patient monitoring.

Cardiovascular parameters, including blood pressure and ECG, should be monitored during therapy with ephedrine. Urinary output should also be monitored.

Use in the elderly.

Ephedrine should also be used with caution in geriatric males, especially those with prostatic hypertrophy, since ephedrine may cause acute urinary retention.

Paediatric use.

Ephedrine Hydrochloride MYX Injection is not approved for use in this patient population.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alpha blockers.

Alpha blockers may decrease the vasopressor effect of ephedrine.

Atropine sulfate.

Atropine sulfate may increase the vasopressor effect of ephedrine.

Beta-blockers.

Beta-blockers may inhibit the cardiac and bronchodilator effects of ephedrine.

Cardiac glycosides.

Concurrent use of cardiac glycosides and ephedrine may increase the risk of arrhythmias.

Ergotamine, ergometrine, methylergometrine, oxytocin.

Concurrent use of these drugs with ephedrine may result in a potentiation of the pressor effect of ephedrine. Concurrent use of ergotamine and ephedrine may also produce peripheral vascular ischaemia and gangrene.

Guanethidine.

Ephedrine may decrease the antihypertensive effect of guanethidine.

Hydrocarbon inhalation anaesthetics, such as cyclopropane, halothane.

These drugs may increase cardiac irritability, and concurrent use with ephedrine may lead to increased risk of arrhythmia (see Section 4.3 Contraindications).

Methyldopa.

Concurrent use of methyldopa with ephedrine may result in a reduced pressor effect.

Monoamine oxidase (MAO) inhibitors.

Concurrent use of MAO inhibitors and ephedrine may result in potentiation of the cardiac and pressor effects of ephedrine (see Section 4.3 Contraindications).

Reserpine.

Concurrent use of reserpine with ephedrine may result in a reduced pressor effect.

Sympathomimetic agents.

Concurrent use of ephedrine and other sympathomimetics may result in increased cardiovascular and pressor effects and an increased risk of adverse effects.

Tricyclic antidepressants.

Concurrent use of tricyclic antidepressant and ephedrine may result in potentiation of the cardiovascular and pressor effects of ephedrine.

Clonidine.

Pretreatment with clonidine may increase the pressor effect of ephedrine.

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

These drugs may increase the half-life and decrease the elimination of ephedrine leading to enhanced therapeutic or toxic effects of ephedrine.

Theophylline.

Concurrent use of ephedrine and theophylline may result in an increased incidence of adverse effects than when either drug is used alone. Adverse effects include those in the central nervous and the gastrointestinal systems.

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

Risk of vasoconstriction and/or of acute episodes of hypertension.

Ergot alkaloids (dopaminergic action).

Risk of vasoconstriction and/or episodes of hypertension.

Noradrenergic-serotoninergic antidepressants (minalcipran, venlafaxine).

Paroxysmal hypertension with possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).

Sibutramine.

Paroxysmal hypertension with possibility of arrhythmia (inhibition of adrenaline or noradrenaline entry in sympathetic fibres).

Antiepileptics.

Increased plasma concentration of phenytoin and possibly of phenobarbitone and primidone.

Doxapram.

Risk of hypertension.

Moclobemide.

Risk of headache and palpitations, and increase in the effect of ephedrine of systolic blood pressure, and diastolic blood pressure.

Linezolid.

Risk of vasoconstriction and/or episodes of hypertension.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The effects of ephedrine on male and female fertility have not been investigated in animal studies.
(Category A)
A Pregnancy Category A drug is defined by the Australian Drug Evaluation Committee as 'Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed'.
Ephedrine may accelerate the foetal heart rate when used to control maternal hypotension during spinal anaesthesia for delivery. Ephedrine Hydrochloride MYX Injection should not be used if the maternal blood pressure is greater than 130/80 Hg.
Ephedrine has been shown to cross the placenta and undergo early metabolism and/or redistribution in the foetus. Ephedrine has been associated with an increased risk of mild metabolic acidosis with increased umbilical plasma concentrations of lactate, glucose, epinephrine, and norepinephrine and greater UV PCO2.
Despite the transplacental passage of ephedrine and notable effects on the cord blood pH; it is uncertain whether this has the potential to affect clinical outcome on the neonate.
Other studies have not demonstrated significant effects on neonatal outcomes.
Ephedrine is distributed into breast milk, and therefore Ephedrine Hydrochloride MYX Injection is not recommended for use during lactation because of the risk of adverse effects in the infant. Therefore, the risk and the benefit of using ephedrine should be avoided or used with caution, and administered to a breast-feeding woman only if necessary.

4.8 Adverse Effects (Undesirable Effects)

Body as a whole.

Pallor, fever, headache, dryness of nose, mouth and throat.
Ephedrine is reported to cause physical addiction after excessive long-term use. Addiction is more likely to occur after oral use, since intramuscular, subcutaneous or intravenous administration of ephedrine would not normally occur over long periods.

Cardiovascular system.

Angina, palpitations, bradycardia, tachycardia, cardiac arrest, hypertension, hypotension, extrasystole and precordial pain. Arrhythmias, including ventricular fibrillation, may occur, especially in patients with organic heart disease or those receiving other drugs that sensitise the heart to arrhythmias.

Vascular disorder.

Cerebral haemorrhage.

Gastrointestinal system.

Nausea, vomiting, reduced appetite, mild epigastric distress, hypersalivation.

Nervous system.

Nervousness, anxiety, restlessness, insomnia, mood or mental changes, fear, irritability, trembling, sweating. Large doses may cause dizziness, lightheadedness, weakness, vertigo, confusion, delirium, euphoria. Long-term therapy in large doses may lead to psychosis characterized by paranoia, hallucinations, depression and bizarre mentation.

Renal and urinary system.

Difficult or painful urination, acute urinary retention (especially with prostatic hypertrophy).

Respiratory system.

Shortness of breath, respiratory difficulty, dyspnoea, pulmonary oedema.

Skin and appendages.

Sweating.

Blood and lymphatic system disorders.

Primary haemostasis modifications.

Immune system disorders.

Hypersensitivity.

Psychiatric disorders.

Confusion, anxiety, depression, psychotic states, fear.

Eye disorders.

Episodes of angle closure glaucoma.

Investigations.

Hypokalaemia, changes in blood glucose levels.

Reporting suspected adverse effects.

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.

4.2 Dose and Method of Administration

Ephedrine Hydrochloride MYX Injection is not approved for use in children (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
Ephedrine Hydrochloride MYX Injection must be diluted prior to administration.
Ephedrine Hydrochloride MYX Injection contains no preservative and is for single use in one patient on one occasion only. Discard any remaining residue.
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.
Dilute 1 mL of Ephedrine Hydrochloride MYX Injection to 10 mL with saline 0.9% to produce a 2.5 mg/mL solution. This solution should be given as a slow intravenous injection of 2.5 to 5 mg (maximum 10 mg), repeated as needed every 3-4 minutes 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.
To reduce microbiological hazard, use as soon as practicable after reconstitution/ preparation. If storage is necessary, hold at 2-8°C for not more than 24 hours.

Compatibilities.

Ephedrine is reported to be compatible with 0.9% sodium chloride and lactated Ringer's injection.

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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

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

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

Ephedrine Hydrochloride MYX Injection is supplied as 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 by taking to your local pharmacy.

Summary Table of Changes