Consumer medicine information

DBL Ergometrine Injection

Ergometrine maleate

BRAND INFORMATION

Brand name

DBL Ergometrine Injection

Active ingredient

Ergometrine maleate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

SUMMARY CMI

DBL™ Ergometrine 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 DBL Ergometrine Injection?

DBL Ergometrine Injection contains the active ingredient ergometrine maleate. DBL Ergometrine Injection is used to prevent and/or treat excessive bleeding in the mother after delivery of a baby or a miscarriage. It works by contracting the uterus and blood vessels.

For more information, see Section 1. Why am I being given DBL Ergometrine Injection? in the full CMI.

2. What should I know before I am given DBL Ergometrine Injection?

You should not be given DBL Ergometrine Injection if you have ever had an allergic reaction to ergometrine, or other medicines belonging to the ergot alkaloid class of medicines (e.g., ergotamine, dihydroergotamine), or any of the ingredients listed at the end of the CMI.

Tell your doctor if you have any other medical conditions, take any other medicines, or plan to breastfeed.

For more information, see Section 2. What should I know before I am given DBL Ergometrine Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Ergometrine Injection 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 is DBL Ergometrine Injection given?

  • Your doctor will decide what dose you will receive. This depends on your condition. Usually only a single dose is required for the treatment and prevention of excessive bleeding.
  • Ergometrine is generally given as an injection into a large muscle. In an emergency situation it may be given as a slow injection into a vein. It must only be given by a doctor or nurse.

More instructions can be found in Section 4. How is DBL Ergometrine Injection given? in the full CMI.

5. What should I know while being given DBL Ergometrine Injection?

Things you should do
  • Tell your doctor or nurse straight away if you experience numbness, coldness or tingling in the fingers or toes during treatment with ergometrine.
  • Tell any other doctors, dentists and pharmacists who are treating you that you have been given DBL Ergometrine Injection.
Looking after your medicine
  • DBL Ergometrine Injection will be stored in the hospital pharmacy or in the ward. It is kept in the refrigerator (between 2°C and 8°C) and away from light.

For more information, see Section 5. What should I know while being given DBL Ergometrine Injection? in the full CMI.

6. Are there any side effects?

  • Side effects include mild headache, nausea, leg cramps, nasal congestion, unusual sweating, unpleasant taste, abdominal pain, mild pain and/or inflammation at the injection site and ringing in the ears. These are usually mild and short-lived. Serious side effects include signs of an allergic reaction (such as difficulty breathing, sudden and/or severe headache, chest pain, palpitations, slow heartbeat, dizziness or faintness), numbness, coldness or tingling in the fingers or toes, sudden, severe headache or pressure in the head, chest pain, angina or palpitations, decreased, increased or irregular heart rate, spasm of the oesophagus (food pipe), convulsions or seizures, blood in the urine, severe pain and/or inflammation at the injection site, gangrene, drowsiness or confusion, nausea, vomiting, diarrhoea, decrease or increase in heart rate, constriction of pupils, unusual thirst, difficulty in breathing, loss of consciousness, severe cramping of the uterus.

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

DBL™ Ergometrine Injection

Active ingredient(s): ergometrine maleate

Consumer Medicine Information (CMI)

This leaflet provides important information about using DBL Ergometrine Injection. 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 DBL Ergometrine Injection.

Where to find information in this leaflet:

1. Why am I being given DBL Ergometrine Injection?
2. What should I know before I am given DBL Ergometrine Injection?
3. What if I am taking other medicines?
4. How is DBL Ergometrine Injection given?
5. What should I know while being given DBL Ergometrine Injection?
6. Are there any side effects?
7. Product details

1. Why am I being given DBL Ergometrine Injection?

DBL Ergometrine Injection contains the active ingredient ergometrine maleate. Ergometrine is an ergot alkaloid. Ergot alkaloids are usually given to stop excessive bleeding that sometimes occurs after delivery of a baby. They work by causing the muscle of the uterus to contract.

DBL Ergometrine Injection is used to prevent and/or treat excessive bleeding in the mother after delivery of a baby or a miscarriage. It works by contracting the uterus and blood vessels.

2. What should I know before I am given DBL Ergometrine Injection?

Warnings

You must not be given DBL Ergometrine Injection if you:

  • are in the first or second stages of labor
  • have any retained placenta
  • have eclampsia or pre-eclampsia (very high blood pressure during pregnancy)
  • are at risk of miscarriage
  • have severe or persistent infection
  • have impaired circulation in blood vessels (peripheral vascular disease)
  • have heart disease, high blood pressure or a history of high blood pressure
  • have impaired liver or kidney function
  • are allergic to ergometrine, or to other medicines belonging to the ergot alkaloid class of medicines (e.g., ergotamine, dihydroergotamine), or to any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. Other symptoms of an allergic reaction to ergometrine may include sudden and/or severe headache, chest pain, palpitations, slow heartbeat, dizziness and/or faintness.

Always check the ingredients to make sure you can use this medicine.

Tell your doctor if you:

  • have disease of the blood vessels of the heart, or other heart problems
  • have hypertension (high blood pressure)
  • have calcium deficiency
  • have porphyria (a disease of the blood).
  • take any medicines for any other condition
  • have allergies to any other medicines, foods, preservatives or dyes
  • smoke (nicotine may alter the effects of ergometrine).

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

Talk to your doctor if you intend to breastfeed.

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 DBL Ergometrine Injection and affect how it works. These include:

  • medicines used to treat and/or prevent angina, such as glyceryl trinitrate
  • beta-blockers, medicines used to treat or prevent high blood pressure and other heart disorders, e.g., angina, irregular heartbeats
  • bromocriptine, a medicine used to halt lactation, treat hormonal problems or to help manage Parkinson's Disease
  • dopamine, a medicine used to treat some heart conditions
  • some antibiotics used to treat infection, e.g., erythromycin, doxycyline or tetracycline
  • some general anaesthetics
  • some medicines used in migraine headaches, e.g., methysergide and sumatriptan.

These medicines may be affected by ergometrine 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 and pharmacist have more information on medicines to be careful with or avoid while being treated with this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DBL Ergometrine Injection.

4. How is DBL Ergometrine Injection given?

How much is given

  • Your doctor will decide what dose you will receive. This depends on your condition. Usually only a single dose is required for the treatment and prevention of excessive bleeding.

How it is given

  • Ergometrine is generally given as an injection into a large muscle. In an emergency situation it may be given as a slow injection into a vein. It must only be given by a doctor or nurse.

If you are given too much DBL Ergometrine Injection

As DBL Ergometrine Injection is given to you in a hospital under the supervision of your doctor it is very unlikely that you will receive an overdose.

If you experience severe side effects and think that you or anyone else may have been given too much DBL Ergometrine Injection you should immediately:

  • tell your doctor or nurse, or
  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

5. What should I know while being given DBL Ergometrine Injection?

Things you should do

Tell your doctor straight away if you:

  • experience numbness, coldness or tingling in the fingers or toes during treatment with ergometrine. Your doctor may decide to stop treatment with ergometrine.

Tell any doctor, dentist or pharmacist that is treating you that you have been given DBL Ergometrine Injection.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DBL Ergometrine Injection affects you.

Looking after your medicine

  • DBL Ergometrine Injection will be stored in the hospital pharmacy or in the ward. It is kept in the refrigerator (between 2°C and 8°C) and away from light.

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.

Side effects

Side effectsWhat to do
Administration site disorders:
  • mild pain and/or inflammation at the injection site
Ear disorders:
  • ringing in the ears
Gastrointestinal disorders:
  • nausea
  • abdominal pain
General disorders:
  • nasal congestion
Musculoskeletal and connective tissue disorders:
  • leg cramps
Nervous system disorders:
  • mild headache
  • unusual sweating
  • unpleasant taste
Speak to your doctor or nurse if you have any of these side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic reaction:
  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin
  • sudden and/or severe headache
  • chest pain, palpitations, slow heartbeat
  • dizziness or faintness
Administration site disorders:
  • severe pain and/or inflammation at the injection site
Cardiac disorders
  • chest pain, angina or palpitations
  • decreased, increased or irregular heart rate
Gastrointestinal disorders:
  • nausea, vomiting, diarrhoea
General disorders:
  • spasm of the oesophagus (food pipe)
  • convulsions or seizures
  • gangrene
  • drowsiness or confusion
  • constriction of pupils
  • unusual thirst
  • loss of consciousness
  • severe cramping of the uterus.
Nervous system disorders:
  • numbness, coldness or tingling in the fingers or toes
  • sudden, severe headache or pressure in the head
Renal and urinary disorders:
  • blood in the urine
Tell your doctor or nurse straight away if you notice any of these serious side effects.
You may need urgent medical attention.

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 that 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 DBL Ergometrine Injection contains

Active ingredient
(main ingredient)		ergometrine maleate
Other ingredients
(inactive ingredients)		maleic acid; water for injections

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

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

What DBL Ergometrine Injection looks like

DBL Ergometrine Injection is a colourless or slightly yellowish solution.

DBL Ergometrine Injection: Aust R 58866.

Who distributes DBL Ergometrine Injection

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

This leaflet was prepared in April 2023.

Published by MIMS June 2023

BRAND INFORMATION

Brand name

DBL Ergometrine Injection

Active ingredient

Ergometrine maleate

Schedule

S4

 

1 Name of Medicine

Ergometrine maleate.

2 Qualitative and Quantitative Composition

Ergometrine is an amine ergot alkaloid. The molecular formula of ergometrine maleate, designated chemically as 9,10-didehydro-N-[(S)-2-hydroxy-1-methylethyl]-6-methylergoline-8-carboxamide hydrogen maleate is C19H23N3O2,C4H4O4.
DBL Ergometrine Injection consists of ergometrine maleate BP and maleic acid BP in water for injections BP. The strength supplied is 500 micrograms/1 mL in a glass ampoule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ergometrine maleate occurs as a white to greyish-white or faintly yellow, odourless, microcrystalline powder which darkens with age and on exposure to light. The BP states that ergometrine maleate is soluble, and the USP that it is sparingly soluble in water; and slightly soluble in alcohol; practically insoluble in chloroform and ether.
DBL Ergometrine Injection is a colourless or slightly yellowish solution for parenteral use. The pH range of the injection is 2.7 to 3.5.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis.

Ergometrine is administered after the delivery of the placenta for the purpose of contracting the uterus in order to prevent postpartum haemorrhage and postabortion haemorrhage due to uterine atony.

Treatment.

Ergometrine is administered after the delivery of the placenta to promote involution of the uterus in order to treat postpartum haemorrhage and postabortion haemorrhage.

4.2 Dose and Method of Administration

Dosage.

Prophylaxis of postpartum haemorrhage and postabortion haemorrhage.

The immediate postpartum dose of ergometrine maleate is 200 micrograms administered intramuscularly. The injection should not be given until completion of the delivery is assured, and until the possibility of a second twin has been excluded (see Section 4.4 Special Warnings and Precautions for Use).
In an emergency situation, 200 micrograms may be injected intravenously. Intravenous (IV) doses should be given slowly, over a period of at least 1 minute. Some clinicians recommend diluting the IV dose to a volume of 5 mL with sodium chloride injection 0.9% before administration (see Section 4.4 Special Warnings and Precautions for Use).

Treatment of postpartum haemorrhage and postabortion haemorrhage.

Ergometrine maleate 200 micrograms may be injected intramuscularly.
Some patients do not respond to ergometrine because of hypocalcaemia. Cautious IV administration of calcium may restore the oxytocic action (see Section 4.4 Special Warnings and Precautions for Use).

Method of administration.

Ergometrine may be administered by intramuscular (IM) or IV injection. However, because the risk of severe adverse effects is increased with IV use of ergometrine, its use via this route is recommended only for emergencies such as excessive uterine bleeding or any (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Ergometrine is contraindicated in patients who have previously displayed hypersensitivity or idiosyncratic reactions to ergometrine, other ergot alkaloids or any of the ingredients in the DBL Ergometrine Injection preparation.
Ergometrine is contraindicated for the induction of labour and during the first and second stages of labour (see Section 4.4 Special Warnings and Precautions for Use).
Ergometrine is contraindicated if there is any suspicion of retained placenta.
Ergometrine is contraindicated in eclampsia or pre-eclampsia, and in cases of threatened spontaneous abortion.
Ergometrine is contraindicated in severe or persistent sepsis.
Ergometrine is contraindicated in patients with peripheral vascular disease or heart disease and in patients with hypertension or a history of hypertension.
Ergometrine is contraindicated where impaired hepatic or renal function exists.

4.4 Special Warnings and Precautions for Use

Calcium deficiency.

In patients with calcium deficiency, the uterus may not respond to ergometrine. Responsiveness can usually be restored by cautious administration of IV calcium salts. However IV calcium should be avoided in patients receiving digitalis.

Coronary artery disease.

Patients may be more susceptible to angina or myocardial infarction caused by ergometrine induced vasospasm.

Heart rate.

Heart rate may be decreased due primarily to an increase in vagal tone, and possibly to decreased central sympathetic activity and direct depression of the myocardium.

Hypertension.

Hypertension may occur following administration of ergometrine especially when administered IV undiluted or too rapidly or when used in conjunction with regional anaesthesia or vasoconstrictors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Ergometrine can cause vasoconstriction and therefore should be used with caution in patients with Raynaud's phenomenon. Treatment should be stopped if sign of vasoconstriction develop.
Some patients, especially eclamptic or previously hypertensive patients, may be unusually sensitive to the hypertensive effects of ergometrine; generalised headaches, severe arrhythmias, seizures, and cerebrovascular accidents have been associated with ergometrine induced hypertension in these patients.
Blood pressure or central venous pressure may be elevated due to peripheral vasoconstriction, primarily of postcapillary vessels. This elevation has sometimes been associated with pre-eclampsia, history of hypertension, IV administration of ergometrine or concurrent use of local anaesthetics containing vasoconstrictors. Hypotension has also been reported.

General anaesthesia.

Because nausea and vomiting may occur, ergometrine should be administered with care to patients under general anaesthesia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Intravenous use.

IV administration of ergometrine produces serious adverse effects if the injections are not diluted and administered slowly. IV use of DBL Ergometrine Injection should be limited to patients with severe uterine bleeding or other life threatening emergency. IV doses should be given slowly, over a period of at least 1 minute. Some clinicians recommend diluting the IV dose to a volume of 5 mL with sodium chloride injection 0.9% before administration.

Labor and delivery.

Ergometrine should not be administered prior to delivery of the placenta (see Section 4.6 Fertility, Pregnancy and Lactation). Before the IV use of ergometrine during severe uterine bleeding, inspection must be made for placental fragments.
High doses of ergometrine administered prior to delivery may cause uterine tetany and problems in the infant (hypoxia, intracranial haemorrhage).
If ergometrine is administered during the second or third stage of labour prior to delivery of the placenta, complications such as captivation of the placenta or missed diagnosis of a second infant due to excessive uterine contraction may occur. The placenta should be delivered, and the possibility of twin pregnancy should be ruled out, before ergometrine is administered.
Uterine overstimulation during labour can cause uterine tetany with uterine rupture, cervical or perineal lacerations, amniotic fluid embolism, or infantile trauma (see Section 4.3 Contraindications).

Porphyria.

Ergometrine has been associated with clinical exacerbations of porphyria.

Prolactin.

Prolactin serum concentrations may be decreased during the postpartum period (see Section 4.6 Fertility, Pregnancy and Lactation).

Prolonged therapy.

Prolonged therapy with ergometrine may lead to gangrene and other signs of ergotism. Numbness or tingling of the extremities indicates the need to discontinue treatment.

Sympathomimetics.

The vasoconstrictor effect of ergometrine is potentiated by sympathomimetics (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Venoatrial shunts or mitral valve stenosis.

Since ergometrine may cause serious adverse cardiovascular effects, ergometrine should be used cautiously or not at all in patients with venoatrial shunts or mitral valve stenosis.

Use in the elderly.

No data available.

Paediatric use.

Elimination of ergometrine may be prolonged in newborns. Neonates inadvertently administered ergometrine in overdose amounts have developed respiratory depression, cyanosis, seizures, decreased urine output, and severe peripheral vasoconstriction.
There have been reports of accidental administration of adult doses of ergometrine to neonates, sometimes instead of vitamin K. Symptoms have included peripheral vasoconstriction, convulsions, respiratory failure, acute renal failure, and temporary lactose intolerance.
In two reports of accidental administration of 0.2 mg of oral ergometrine maleate or of 0.5 mg of IM ergometrine maleate to neonates, peripheral cyanosis and gangrene, apnoea, myoclonic movements, purpuric manifestations, and mild jaundice were noted. Treatment was mainly supportive; IV chlorpromazine controlled myoclonic movements. One death has been reported in an infant who received 0.2 mg of oral ergometrine maleate.

Effects on laboratory tests.

Prolactin serum concentrations may be decreased during the postpartum period.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antianginal agents.

Ergot alkaloids may induce coronary vasospasm and may precipitate angina. The efficacy of glyceryl trinitrate or other antianginal agents may be reduced; increased doses of glyceryl trinitrate or antianginal agents may be necessary.

Beta blockers.

Ergot causes vasoconstriction. The beta blockers do the same by blocking the normal beta-2-stimulated sympathetic vasodilatation. Ergot alkaloids have been reported to interact with beta-blockers resulting in excessive, additive peripheral vasoconstriction.

Bromocriptine.

The use of ergot alkaloids may increase the incidence of rare cases of hypertension, strokes, seizures, and myocardial infarction associated with the postpartum use of bromocriptine.

Dopamine.

Ergot alkaloids have been reported to interact with dopamine resulting in excessive peripheral vasoconstriction. Gangrene and peripheral ischaemia of hands and feet developed in a patient receiving both dopamine and ergometrine infusions. In addition, dopamine has been associated with pedal gangrene secondary to peripheral vasoconstriction and the combination of an ergot alkaloid may accentuate this effect. It would seem prudent to avoid concurrent use.

Doxycycline and tetracycline.

Although not documented with ergometrine, five patients taking ergotamine or dihydroergotamine developed ergotism when additionally treated with doxycycline or tetracycline. The importance of this interaction is uncertain. Be alert for any signs of ergotism in any patient given ergot derivatives and any of the tetracyclines. Impairment of liver function may possibly be a contributory factor.

Erythromycin.

Although not documented with ergometrine, ergot toxicity can develop rapidly in patients on ergotamine or dihydroergotamine if they are given erythromycin.

General anaesthetics.

Concurrent use of general anaesthetics may potentiate peripheral vasoconstriction.

Glyceryl trinitrate.

Ergot alkaloids may induce coronary vasospasm and may precipitate angina. The efficacy of glyceryl trinitrate or other antianginal agents may be reduced; increased doses of glyceryl trinitrate or antianginal agents may be necessary. Glyceryl trinitrate may also reduce the first-pass hepatic metabolism of dihydroergotamine.

Halothane.

Halothane in concentrations greater than 1% may interfere with the oxytocic actions of ergometrine, resulting in severe uterine haemorrhage.

Methysergide.

The concurrent use of ergot alkaloids and methysergide can increase the risk of severe and persistent spasm of major arteries in some patients. The combination should be used with great caution.

Nicotine.

Enhanced vasoconstriction may result from the combined effects of nicotine absorption from heavy smoking and administration of ergometrine.

Sumatriptan.

Although not documented with ergometrine, it has been suggested that the concurrent use of sumatriptan and ergotamine be avoided because of the theoretical risk of additive vasospastic reaction, in particular coronary vasoconstriction.

Tetracycline.

See Doxycycline and tetracycline above.

Vasoconstrictors, including those present in some local anaesthetics, or vasopressors.

Concurrent use may result in enhanced vasoconstriction; dosage adjustments may be necessary.
The pressor effect of sympathomimetic pressor amines may be potentiated, resulting in potentially severe hypertension, headache, and rupture of cerebral blood vessels; gangrene developed in a patient receiving both dopamine and ergometrine infusions.
Also see Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Category C: Drugs, which owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Ergometrine induces uterine contraction and may cause premature parturition or hypertonic labour. Tetanic contractions may result in decreased uterine blood flow and foetal distress (see Section 4.4 Special Warnings and Precautions for Use). Products containing ergometrine should therefore be avoided as far as possible during pregnancy.
 Ergometrine is secreted in breast milk. Ergot alkaloids have the potential to cause chronic ergot poisoning in the infant if used in higher than recommended doses or if used for a longer period of time than is generally recommended. Ergometrine is therefore contraindicated during breastfeeding.

Note.

Ergot preparations are frequently given as a single dose postpartum to control haemorrhage. A single dose of ergometrine should not prevent the mother from breastfeeding.
The use of multiple doses in postpartum patients may lower prolactin levels and suppress lactation.

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)

When administered in correct doses to carefully selected patients who are closely monitored, there is little risk of serious adverse systemic effects in patients receiving ergometrine. However, IV administration of the drugs produces serious adverse effects if the injections are not diluted and administered slowly (see Section 4.4 Special Warnings and Precautions for Use).
Adverse effects do not appear to occur as frequently with ergometrine as with other ergot alkaloids. Ergometrine is usually indicated for a short duration and, as a consequence, many of the side effects seen with the other ergot alkaloids do not occur.
Adverse reactions which have been observed following administration of ergometrine include:

Body as a whole.

Gangrene (ergometrine shows less tendency to produce gangrene than ergotamine), headache, abdominal pain, allergic phenomena (including shock, hypertension, chest pain, palpitation, dyspnoea and bradycardia).

Cardiovascular system.

Coronary artery vasospasm, peripheral vasospasm, hypotension, hypertension (possibly sudden and/or severe [see Section 4.4 Special Warnings and Precautions for Use]), thrombophlebitis, myocardial infarction (single case report), ventricular arrhythmias; and transient chest pain, palpitation, and bradycardia alone or as part of allergic phenomena (see Body as a whole).
Hypertension may occur following administration of ergometrine especially when administered IV undiluted or too rapidly or when used in conjunction with regional anaesthesia or vasoconstrictors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Digestive system.

Diarrhoea, nausea, oesophageal spasm, vomiting.
Mesenteric ischaemia and large bowel infarction have been reported (single case report).

Metabolic and nutritional.

Water intoxication.

Musculoskeletal system.

Leg cramps, unmasking of myasthenia gravis (single case report).

Nervous system.

Dizziness, hallucinations, vertigo.

Respiratory system.

Dyspnoea alone or as part of allergic phenomena (see Body as a whole); nasal congestion, pulmonary oedema, pleural thickening.

Skin and appendages.

Sweating.

Special senses.

Unpleasant taste, tinnitus.

Urogenital system.

Haematuria.

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.

4.9 Overdose

Symptoms.

The principal manifestations of serious overdose are convulsions and gangrene.
Other symptoms of overdose include the following:
bradycardia, confusion, diarrhoea, dizziness, dyspnoea, drowsiness, fast and/or weak pulse, miosis, hypercoagulability, loss of consciousness, nausea and vomiting, numbness and coldness of the extremities, pain in the chest, peripheral vasoconstriction, respiratory depression, rise or fall in blood pressure, severe cramping of the uterus, tachycardia, tingling, unusual thirst.
There have been reports of accidental administration of adult doses of ergometrine maleate to neonates, sometimes instead of vitamin K. Symptoms have included peripheral vasoconstriction, convulsions, respiratory failure, acute renal failure, and temporary lactose intolerance (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).
In two reports of accidental administration of 0.2 mg of oral ergometrine maleate or 0.5 mg of IM ergometrine maleate to neonates, peripheral cyanosis and gangrene, apnoea, myoclonic movements, purpuric manifestations, and mild jaundice were noted. Treatment was mainly supportive; IV chlorpromazine controlled myoclonic movements. One death was reported in an infant who received 0.2 mg of oral ergometrine maleate (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use).

Treatment.

There is no specific antidote for the management of ergometrine overdose. Supportive and symptomatic treatment should be initiated.
Ergometrine should be discontinued immediately.
Convulsions should be treated with appropriate anticonvulsants, e.g. phenytoin or diazepam.
Hypercoagulability should be controlled by the administration of heparin.
Severe hypertension may require treatment with sodium nitroprusside or hydralazine.
Peripheral ischaemia may be treated with sodium nitroprusside or phentolamine. Gangrene may require surgical amputation.
A vasodilator, e.g. glyceryl trinitrate, may be required for myocardial ischaemia and/or hypertension. The vasodilator should be administered with dosage adjusted according to heart rate and blood pressure.
ECG monitoring may be required to assess cardiac function and perfusion. Frequent monitoring of vital signs as well as blood gases and electrolytes is recommended.
Monitoring of serum ergometrine levels is not predictive of the outcome of overdose.
It is not known if use of forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion will hasten the elimination of ergometrine, especially in overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand, call 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ergometrine stimulates contractions of uterine and vascular smooth muscle.
Following administration of usual therapeutic doses of ergometrine, intense contractions of the uterus are produced and are usually followed by periods of relaxation. Larger doses of the drugs, however, produce sustained, forceful contractions followed by only short or no periods of relaxation.
Ergometrine increases the amplitude and frequency of uterine contractions and uterine tone which in turn impedes uterine blood flow. Contraction of the uterine wall around bleeding vessels at the placental site produces haemostasis. Ergometrine also increases contractions of the cervix.
Ergometrine produces vasoconstriction, mainly of capacitance vessels; increased central venous pressure, elevated blood pressure, and, rarely, peripheral ischaemia and gangrene may result. Like other ergot alkaloids, ergometrine produces arterial vasoconstriction by stimulation of alpha-adrenergic and serotonin receptors and inhibition of endothelial-derived relaxation factor release. The drug has only slight alpha-adrenergic blocking activity and its vasoconstrictor effects are less than those of ergotamine.
The main clinical use of ergometrine is in the production of rhythmic contractions of the uterus.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Ergometrine has a rapid onset of action following IV injection. Uterine contractions are usually initiated almost immediately or within 1 minute and persist for 45 minutes after IV injection.
Ergometrine is also reported to be rapidly and completely absorbed after IM injection with uterine contractions initiated within 2 to 5 minutes. Uterine contractions persist for 3 hours or longer after IM administration.

Distribution.

Distribution of ergometrine has not been fully characterised.

Metabolism/excretion.

Little is known about the elimination of ergometrine. Elimination of ergometrine appears to be principally by metabolism in the liver. It has been suggested that ergometrine is principally eliminated by nonrenal mechanisms (i.e. metabolism in the liver, excretion in faeces). Elimination of ergometrine may be prolonged in neonates.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Maleic acid, water for injections.

6.2 Incompatibilities

Ergometrine has been reported to be incompatible with solutions containing the following: adrenaline hydrochloride, amylobarbitone sodium, ampicillin sodium, cephalothin sodium, chloramphenicol sodium succinate, chlortetracycline hydrochloride, heparin sodium, metaraminol tartrate, methicillin sodium, nitrofurantoin sodium, novobiocin sodium, pentobarbitone sodium, sulphadiazine sodium, sulphafurazole diethanolamine, thiopentone sodium, vitamin B complex with C, warfarin sodium.
Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

The ampoules are to be stored at 2 to 8°C and protected from light.

6.5 Nature and Contents of Container

DBL Ergometrine Injection is supplied in glass ampoules and is available in the following strengths and pack sizes:

Strength.

500 microgram/mL.

Volume.

1 mL.

Pack.

5's.

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.

The structural formula of ergometrine maleate is shown below:
Its molecular weight is 441.5.

CAS number.

The CAS registry numbers of ergometrine and ergometrine maleate are 60-79-7 and 129-51-1 respectively.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription only Medicine).

Summary Table of Changes