ERGOMETRINE Injection Ref.[8638] Active ingredients: Ergometrine

Ergometrine may give rise to widespread vasoconstriction and rarely acute pulmonary oedema.

Active management of the third stage of labour requires expert obstetric supervision.

In breech presentations and other abnormal presentations, Ergometrine Injection, should not be given until after delivery of the child, and in multiple births not until the last child has been delivered (see section 4.6 Fertility, pregnancy and lactation).

Ergometrine derivatives are excreted in breast milk but in unknown amounts. It can also suppress lactation, so repeated use should be avoided (see section 4.6 Fertility, pregnancy and lactation).

Caution is required in patients with mild or moderate hypertension, or with mild or moderate degrees of cardiac, liver or kidney disease. Severe forms are contraindications (see section 4.3 Contraindications).

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

If in the treatment of postpartum haemorrhage, bleeding is not arrested by the injection, the possibility of a retained placental fragment, or soft tissue injury (cervical or vaginal laceration), or of a clotting defect should be considered and appropriate measures taken before a further injection is given.

Ergot alkaloids are substrates of CYP3A4. The concomitant use of Ergometrine Injection with strong CYP3A4 inhibitors such as macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine), or azole antifungals (e.g. ketoconazole, itraconazole, voriconazole) should be avoided, since this can result in an elevated exposure to methylergometrine and ergot toxicity (vasospasm and ischaemia of the extremities and other tissues).Caution should be exercised when Ergometrine Injection is used concurrently with other vasoconstrictors or other ergot alkaloids. Concurrent use of vasoconstrictors and Ergometrine Injection after delivery during anaesthesia may lead to severe postpartum hypertension. Methylergometrine may enhance the vasoconstrictor/vasopressor effects of other drugs such as triptans (5HT_1B/1D receptor agonists), sympathomimetics (including those in local anaesthetics), beta-blockers or other ergot alkaloids (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Caution is required when using Ergometrine Injection alone or in combination with prostaglandins and their analogues in the treatment of postpartum atonic uterine haemorrhage (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Concomitant use of Ergometrine Injection with the following medicinal products is not recommended:

Vasoconstrictors/Sympathomimetics: Ergometrine Injection may enhance the vasopressor effects of vasoconstrictors and sympathomimetics, even those contained in local anaesthetics.

Prostaglandins and their analogues: Prostaglandins and their analogues facilitate contraction of the myometrium hence Ergometrine Injection can potentiate the uterine action of prostaglandins and analogues and vice versa.

CYP3A4 inhibitors: Strong CYP3A4 inhibitors such as protease inhibitors, macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine), azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), quinolones might raise the levels of ergot derivatives, which may lead to ergotism. Combined use with Ergometrine should be avoided. Other weaker CYP3A4 inhibitors (e.g cimetidine, delavirdine, grapefruit juice, quinupristin, dalfopristin) might interact similarly, although possibly to a lesser extent.

Ergot alkaloids/ergot derivatives: Concurrent use of other ergot alkaloids (e.g methysergide) and other ergot derivatives can increase the risk of severe and persistent spasm of major arteries in some patients.

Triptans: Additive vasoconstriction may occur when ergometrine is concomitantly given with triptans (e.g. sumatriptan, zolmitriptan, rizatriptan, almotriptan, eletriptan).

Beta-blockers: Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.

Glyceryl trinitrate and other antianginal drugs: Ergometrine produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs.

Consideration should be given to the concomitant use of Ergometrine Injection with the following medicinal products:

Inhalation anaesthetics: Inhalation anaesthetics (e.g. halothane, cyclopropane, sevoflurane, desflurane, isoflurane) have a relaxing effect on uterus and produce a notable inhibition of uterine tone and thereby, may diminish the uterotonic effect of ergometrine.

CYP3A4 inducers: CYP3A4 inducers (e.g. nevirapine, rifampicin) may reduce the clinical effect of ergometrine.

Pregnancy

Ergometrine has potent uterotonic activity. Therefore, Ergometrine Injection is contraindicated during pregnancy, during induction of labour, and during first and second stage labour prior to the delivery of the anterior shoulder (see section 4.3 Contraindications).

In breech presentation and other abnormal presentations, Ergometrine Injection should not be given before delivery of the child is completed, and in multiple births not before the last child has been delivered (see section 4.4 Special warnings and precautions for use).

Breast-feeding

Ergometrine derivatives are excreted in breast milk but in unknown amounts. There is no specific data available for elimination of ergometrine partitioned in breast-milk. Ergometrine can inhibit prolactin secretion and in turn can suppress lactation, so its repeated use should be avoided.

Receiving Ergometrine Injection can start labour. Women with contractions should not drive or use machines. Patients should be warned of the possibility of dizziness and hypotension (see section 4.8 Undesirable effects).

Immune system disorders: Anaphylactic/Anaphylactoid reactions with associated symptoms of dyspnoea, hypotension, collapse or shock

Nervous system disorders: Headache, dizziness

Ear & labyrinth disorders: Tinnitus

Cardiac disorders: Cardiac arrhythmias, palpitations, bradycardia, chest pain, coronary arteriospasm with very rare reports of myocardial infarction (see section 4.4 Special warnings and precautions for use)

Vascular disorders: Hypertension, vasoconstriction

Respiratory disorders: Dyspnoea, pulmonary oedema

Gastrointestinal disorders: Nausea, vomiting, abdominal pain

Skin & subcutaneous tissue disorders: Skin rashes

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ergometrine Injection is incompatible with various drugs according to resulting Ph, temperature and concentration of drugs. Mixing with other drugs in the same syringe should therefore be avoided. Ergometrine may, however, be diluted to a volume of 5mls with 0.9% Sodium Chloride Injection prior to IV administration.