Syntometrine Ampoules

1. Name Of The Medicinal Product

Syntometrine^® Ampoules

2. Qualitative And Quantitative Composition

Each 1ml ampoule contains 5IU oxytocin PhEur and 0.5mg ergometrine maleate PhEur.

3. Pharmaceutical Form

A clear colourless sterile liquid in a 1ml clear colourless glass ampoule.

4. Clinical Particulars

4.1 Therapeutic Indications

The active management of the third stage of labour, or routinely, following the birth of the placenta, to prevent or treat postpartum haemorrhage.

4.2 Posology And Method Of Administration

Syntometrine is usually administered by intramuscular injection.

Adults:

Active management of third stage of labour: Intramuscular injection of 1ml after delivery of the anterior shoulder, or at the latest, immediately after delivery of the child. Expulsion of the placenta, which is normally separated by the first strong uterine contraction, should be assisted by gentle suprapubic pressure and controlled cord traction.

Prevention and treatment of postpartum haemorrhage: Intramuscular injection of 1ml following expulsion of the placenta, or when bleeding occurs.

Third stage of labour and postpartum haemorrhage: Syntometrine may also be administered by a slow intravenous injection in a dose of 0.5 to 1ml. This route of administration is not generally recommended.

Children: Not applicable.

Elderly: Not applicable.

4.3 Contraindications

Hypersensitivity to any of the components.

Pregnancy, first stage of labour, primary or secondary uterine inertia. Second stage of labour before crowning of the head.

Severe disorders of cardiac, liver or kidney functions; occlusive vascular disease, sepsis, severe hypertension, pre-eclampsia, eclampsia.

4.4 Special Warnings And Precautions For Use

When the intravenous route is employed, care should be exercised in patients of doubtful cardiac status.

In breech presentations and other abnormal presentations, Syntometrine should not be given until after delivery of the child, and in multiple births not until the last child has been delivered. In postpartum haemorrhage, if bleeding is not arrested by the injection of Syntometrine, the possibility of retained placental fragments, of soft tissue injury (cervical or vaginal laceration), or of a clotting defect, should be excluded before a further injection is given. Caution should be exercised in the presence of mild or moderate hypertension, or with mild or moderate degrees of cardiac, liver or kidney disease.

Patients with coronary artery disease may be more susceptible to angina or myocardial infarction caused by ergometrine-induced vasospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Halothane anaesthesia may diminish the uterotonic effect of Syntometrine. Syntometrine may enhance the effects of vasoconstrictors and of prostaglandins.

4.6 Pregnancy And Lactation

See Section 4.1 “Therapeutic Indications”.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nausea, vomiting, abdominal pain, headache, dizziness and skin rashes. On rare occasions hypertension, bradycardia, cardiac arrhythmias, chest pain or anaphylactoid reactions associated with dyspnoea, hypotension, collapse or shock.

Cardiac disorders: coronary arteriospasm with very rare reports of myocardial infarction

4.9 Overdose

No case of maternal intoxication with Syntometrine has been reported to the company. If such a case were to occur the most likely symptoms would be those of ergometrine intoxication: nausea, vomiting, hypertension or hypotension, vasospastic reactions, respiratory depression, convulsions, coma. Treatment would have to be symptomatic.

Accidental administration to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms such as respiratory depression, convulsions and hypertonia, heart arrhythmia have been reported. Treatment has been symptomatic in most cases; respiratory and cardiovascular support have been required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Syntometrine combines the known sustained oxytocic action of ergometrine with the more rapid action of oxytocin on the uterus.

5.2 Pharmacokinetic Properties

Ergometrine is reported to be rapidly and completely absorbed after an intramuscular injection. Uterine stimulation occurs within 7 minutes of im injection and immediately after iv injection. Oxytocin is also rapidly absorbed and is rapidly metabolised by the liver and the kidneys.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride, maleic acid, water for injections.

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

For prolonged periods store between 2^o and 8^oC. Protect from light. Syntometrine may be stored up to 25^oC for 2 months when protected from light, but must then be discarded.

6.5 Nature And Contents Of Container

Uncoloured borosilicate glass Type I snap ampoule. Packs of 5 ampoules.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL16853/0021

9. Date Of First Authorisation/Renewal Of The Authorisation

25 June 1998

10. Date Of Revision Of The Text

12 April 2010

Legal Status

POM

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.