OXYTOCIN

Induction or enhancement of labour:

Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Oxytocin should be administered as an IV (intravenous) drip infusion or, preferably, by means of a variable-speed infusion pump. 9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see section

As there is a wide variation in uterine sensitivity, uterine spasm may be caused in some instances by what are normally considered to be low doses. When oxytocin is used by IV infusion for the induction or enhancement of labour, administration at too high doses results in uterine overstimulation which may cause foetal distress, asphyxia, and death, or may lead to hypertonicity, tetanic contractions, soft tissue damage or rupture of the uterus.

4 Special warnings and precautions for use). These rapid haemodynamic changes may result in myocardial ischaemia, particularly in patients with pre-existing cardiovascular disease. Rapid IV bolus injection of oxytocin at doses amounting to several IU may also lead to QTc prolongation.

4 Special warnings and precautions for use). 4 Special warnings and precautions for use). 4. Special warnings and precautions for use). Symptoms of water intoxication include: 1. Headache, anorexia, nausea, vomiting and abdominal pain. 2.

Lethargy, drowsiness, unconsciousness and grand-mal type seizures. 3. Low blood electrolyte concentration. Undesirable effects (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports; not known (cannot be estimated from the available data).

The ADRs tabulated below are based on clinical trial results as well as postmarketing reports. The adverse drug reactions derived from post-marketing experience with Oxytocin are via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.

Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. Table 1 Adverse drug reactions in mother System organ class Adverse drug reaction Immune system disorders Rare: Anaphylactic/Anaphylactoid reaction associated with dyspnoea, hypotension or Anaphylactic/Anaphylactoid Shock Nervous system disorders Common: Headache Cardiac disorders Common: Tachycardia, bradycardia Uncommon: Arrhythmia Not known: Myocardial ischaemia, Electrocardiogram QTc prolongation Vascular disorders Not known: Hypotension, haemorrhage Gastrointestinal disorders Common: Nausea, vomiting Skin and subcutaneous tissue disorders Rare: Rash Not Known: Angioedema Pregnancy, puerperium and perinatal conditions Not known: Uterine hypertonus, tetanic contractions of uterus, rupture of the uterus Metabolism and nutrition disorders Not known: Water intoxication, maternal hyponatraemia Respiratory, thoracic and mediastinal disorders Not known: acute pulmonary oedema General disorders and administration site conditions Not known: Flushing Blood and lymphatic system disorders Not known: disseminated intravascular coagulation Table 2 Adverse drug reactions in foetus/neonate System organ class Adverse drug reaction Pregnancy, puerperium and perinatal conditions Not known: foetal distress syndrome, asphyxia and death Metabolism and nutrition disorders Not known: Neonatal hyponatraemia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

). To ensure even mixing, the bottle or bag must be turned upside down several times before use. The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established.

In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). , 10 IU in 500ml. When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced.

In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately. 3 Contraindications). In women given Oxytocin for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Incomplete, inevitable, or missed abortion: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by IV infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

). In women given Oxytocin for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter. Incomplete, inevitable, or missed abortion: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by IV infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage:

The usual dose is 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta.

Treatment of postpartum uterine haemorrhage: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by IV infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration:

Intravenous infusion. Special populations Renal impairment No studies have been performed in renally impaired patients. Hepatic impairment No studies have been performed in hepatically impaired patients. Paediatric population No studies have been performed in paediatric patients.