DBL™ Ergometrine Injection

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

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.

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.

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.

• 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.

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

• 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.

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

4.9 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

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The structural formula of ergometrine maleate is shown below:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSERGMAL.gif 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

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DBLERGST.gif