Consumer medicine information

DBL Ephedrine Sulfate Injection

Ephedrine sulfate

BRAND INFORMATION

Brand name

DBL Ephedrine Sulfate Injection

Active ingredient

Ephedrine sulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Ephedrine Sulfate Injection.

What is in this leaflet

This leaflet answers some common questions about DBL™ Ephedrine Sulfate Injection. It does not contain all the available information.

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

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Ephedrine Sulfate Injection against the benefits this medicine is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet in a safe place. You may need to read it again.

What DBL™ Ephedrine Sulfate Injection is used for

DBL™ Ephedrine Sulfate Injection is used to treat bronchial asthma, reversible spasm of the airways, and some forms of shock. It is also used to treat the low blood pressure which may occur during spinal anaesthesia.

It works by relaxing some of the muscles in your airways, stimulating your heart, and contracting the blood vessels in your limbs, so that more blood is available for your brain, heart and lungs.

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.

DBL™ Ephedrine Sulfate Injection is available only with a doctor’s prescription.

Before you are given DBL™ Ephedrine Sulfate Injection

When you must not be given it

You should not be given DBL™ Ephedrine Sulfate Injection 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
  • 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 DBL™ Ephedrine Sulfate Injection:

  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 problems
    - thyroid problems
    - diabetes
  2. if you are pregnant or intend to become pregnant
    Your doctor will discuss the risks and benefits of using DBL™ Ephedrine Sulfate Injection during pregnancy.
  3. if you are breast-feeding or plan to breast-feed
    Your doctor will discuss the risks and benefits of using DBL™ Ephedrine Sulfate Injection when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Ephedrine Sulfate Injection.

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 DBL™ Ephedrine Sulfate Injection. These include:

  • Medicines used to treat heart failure (eg digoxin).
  • alpha blockers or beta blockers (used to treat high blood pressure, eg prazosin, propranolol or methyldopa)
  • Medicines used to control depression such as monoamine oxidase (MAO) inhibitors (eg phenelzine or moclobemide) and tricyclic antidepressants (eg dothiepin or amitriptyline)
  • Medicines used in the treatment of migraine such as ergotamine
  • Theophylline (a medicine used to treat asthma)
  • Acetazolamide, dichlorphenamide, sodium bicarbonate, sodium citrate (medicines that make urine less acidic ie alkaline)

These medicines may be affected by DBL™ Ephedrine Sulfate Injection, 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 DBL™ Ephedrine Sulfate Injection.

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

How DBL™ Ephedrine Sulfate Injection is given

DBL™ Ephedrine Sulfate Injection can be given in three ways:

  • as an slow injection into a vein
  • as a deep injection into a large muscle
  • as an injection under the skin

DBL™ Ephedrine Sulfate Injection must only be given by a doctor or nurse.

Your doctor will decide what dose of DBL™ Ephedrine Sulfate Injection 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 take too much (overdose)

As DBL™ Ephedrine Sulfate Injection 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, in New Zealand, call 0800 764 766) 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 DBL™ Ephedrine Sulfate Injection.

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 or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Ephedrine Sulfate Injection. DBL™ Ephedrine Sulfate Injection 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 or pharmacist 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 DBL™ Ephedrine Sulfate Injection. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After being given DBL™ Ephedrine Sulfate Injection

Storage

DBL™ Ephedrine Sulfate Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C, and it is protected from light.

Product description

What it looks like

DBL™ Ephedrine Sulfate Injection is a clear, colourless solution.

Ingredients

Active Ingredients:

  • ephedrine sulfate

Other Ingredients:

  • sodium chloride
  • water for injection.

DBL™ Ephedrine Sulfate Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier / Sponsor

DBL™ Ephedrine Sulfate Injection is supplied by:

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number : 1800 675 229
www.pfizer.com.au

DBL™ Ephedrine Sulfate Injection is available in the following strength and pack size:

30 mg/1 mL, 5 ampoules per pack. AUST R 16325

This leaflet was prepared in June 2019.

Published by MIMS September 2019

BRAND INFORMATION

Brand name

DBL Ephedrine Sulfate Injection

Active ingredient

Ephedrine sulfate

Schedule

S4

 

1 Name of Medicine

Ephedrine sulfate.

2 Qualitative and Quantitative Composition

DBL Ephedrine Sulfate Injection is a sterile solution of ephedrine sulfate in water for injections. Each mL contains 30 mg of ephedrine sulfate and 3 mg of sodium chloride in water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Ephedrine Sulfate is a clear colourless solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Ephedrine Sulfate Injection is indicated in the treatment of shock unresponsive to fluid replacement. It is also indicated in the treatment of hypotension secondary to spinal anaesthesia.
DBL Ephedrine Sulfate Injection has also been used in the treatment of bronchial asthma and reversible bronchospasm although more selective agents (beta-adrenergic agonists) are now available.

4.2 Dose and Method of Administration

Dosage.

As a pressor.

Adult dose.

The usual adult dose is 25 to 50 mg (range 10 to 50 mg) administered intramuscularly or subcutaneously. Additional doses should be based on patient response. The intravenous route may be used if an immediate response is required. The dosage for the intravenous route is 10 to 25 mg which may be repeated every 5 to 10 minutes until the desired response is obtained.

Paediatric dose.

The recommended paediatric dose is 3 mg/kg/day or 100 mg/m2/day via the intravenous or subcutaneous route, given in 4 to 6 divided doses.
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.
Bronchospasm.

Adult dose.

The usual adult dose is 12.5 to 25 mg, given intramuscularly, subcutaneously or intravenously. Further dosage should be determined by patient's response.

Paediatric dose.

The usual paediatric dose is 3 mg/kg or 100 mg/m2 intravenously or subcutaneously, given in 4 to 6 divided doses.

Method of administration.

DBL Ephedrine Sulfate Injection is administered by the intramuscular, subcutaneous or intravenous route. Patients in shock may require intravenous administration to ensure absorption of the drug. When administered intravenously, the injection should be given slowly. Care should be taken to avoid extravasation, since this may result in tissue necrosis and sloughing. Ephedrine sulfate should be administered in the lowest effective dose. The parenteral adult dose should not exceed 150 mg in 24 hours.

Compatibilities.

Ephedrine sulfate is reported to be compatible with 0.9% sodium chloride, lactated Ringer's injection, and 10% glucose in water.

4.3 Contraindications

DBL Ephedrine Sulfate Injection is contraindicated in closed angle glaucoma, since ephedrine may exacerbate the condition.
Ephedrine sulfate is contraindicated in patients with pheochromocytoma, since severe hypertension may result.
Ephedrine sulfate is contraindicated in patients with asymmetric septal hypertrophy (idiopathic hypertrophic subaortic stenosis) since the obstruction may increase as myocardial contractility improves.
Ephedrine sulfate 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 sulfate 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 sulfate is contraindicated in patients with tachyarrhythmias or ventricular fibrillation, since exacerbation of these conditions may occur.
Ephedrine sulfate 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.
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 sulfate 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 sulfate 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 sulfate should also be used with caution in diabetic patients since drug induced hyperglycaemia may result in loss of diabetic control.
Ephedrine sulfate 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.

Patient monitoring.

Cardiovascular parameters, including blood pressure, ECG, cardiac output, central venous pressure and pulmonary artery pressure should be monitored during therapy with ephedrine. Urinary output should also be monitored.

Use in the elderly.

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

Paediatric use.

No data available.

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

Guanethidine.

Ephedrine sulfate 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 sulfate may lead to increased risk of arrhythmia (see Section 4.3 Contraindications).

Methyldopa.

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

Monoamine oxidase (MAO) inhibitors.

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

Reserpine.

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

Sympathomimetic agents.

Concurrent use of ephedrine sulfate 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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category 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'.
DBL Ephedrine Sulfate Injection may accelerate the foetal heart rate when used to control maternal hypotension during spinal anaesthesia for delivery. DBL Ephedrine Sulfate Injection should not be used if the maternal blood pressure is greater than 130/80 mmHg.
 Ephedrine sulfate is distributed into breast milk, and therefore DBL Ephedrine Sulfate Injection is not recommended for use during lactation because of the risk of adverse effects in the infant.

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.

Pallor, fever, headache, dryness of nose, mouth and throat.
Ephedrine sulfate 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 sulfate would not normally occur over long periods.

Cardiovascular system.

Angina, palpitations, bradycardia, tachycardia, 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.

Digestive system.

Nausea, vomiting, mild epigastric distress.

Nervous system.

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

Genito-urinary system.

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

Respiratory system.

Shortness of breath, respiratory difficulty, dyspnoea.

Skin and appendages.

Sweating.

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 www.tga.gov.au/reporting-problems.

4.9 Overdose

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 (e.g. propranolol) to control tachycardia and arrhythmia; phentolamine or 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 Poisons Information Centre on 13 11 26 (Australia), 0800 764 766 (New Zealand).

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 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.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Ephedrine is rapidly absorbed after intramuscular or subcutaneous administration.

Distribution.

The onset of action after intramuscular administration is 10 to 20 minutes, and the duration of pressor and cardiac responses to ephedrine is 1 hour after intravenous administration of 10 to 25 mg or intramuscular or subcutaneous administration of 25 to 50 mg.

Metabolism.

Small quantities of ephedrine are metabolised in the liver, but the majority of ephedrine is excreted unchanged in the urine.

Excretion.

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.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride; water for injections.

6.2 Incompatibilities

Ephedrine sulfate 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

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

Strength.

30 mg/mL.

Pack size.

5 x 1 mL ampoules.

Code.

8360B.

ARTG no.

AUST R 16325.

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

The molecular formula of ephedrine sulfate is (C10H15NO)2.H2SO4. Its molecular weight is 428.5.

Chemical structure.


CAS number.

The CAS registry number of ephedrine sulfate is 134-72-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes