Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Antepartum:
Postpartum:
Induction or enhancement of labour: Oxytocin should not be started for 6 hours, following administration of vaginal prostaglandins. Oxytocin should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Oxytocin be added to 500ml of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent (see Section 4.4 “Special warnings and precautions for use”). 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 10milliunits/minute (20 drops/minute), and the recommended maximum rate is 20milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated oxytocin solution, e.g. 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.
If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4milliunits/minute (see Section 4.3 “Contra-indications”).
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 i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.
Caesarean section: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. 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 i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. 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 i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by i.v. 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.
Intravenous infusion.
No studies have been performed in renally impaired patients.
No studies have been performed in hepatically impaired patients.
No studies have been performed in paediatric patients.
No studies have been performed in elderly patients (65 years old and over).
The fatal dose of oxytocin has not been established. Oxytocin is subject to inactivation by proteolytic enzymes of the alimentary tract. Therefore it is not absorbed from the intestine and is not likely to have toxic effects when ingested.
The symptoms and consequences of overdosage are those mentioned under sections 4.4 “Special warnings and precautions for use” and 4.8 “Undesirable effects”. In addition, as a result of uterine overstimulation, placental abruption and/or amniotic fluid embolism have been reported.
When signs or symptoms of overdosage occur during continuous i.v. administration of oxytocin, the infusion must be discontinued at once and oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur. In the case of coma, a free airway should be maintained with routine measures normally employed in the nursing of the unconscious patient.
Three years.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store between 2°C and 8°C. May be stored up to 30°C for 3 months, but must then be discarded.
Store in the original package in order to protect from light.
Clear, Type I, neutral glass, 1ml ampoules. Boxes of 10 or 5 ampoules. Not all packs sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Snap ampoules: no file required.
Oxytocin is compatible with the following infusion fluids, but due attention should be paid to the advisability of using electrolyte fluids in individual patients: 6% dextran 60 or 70 (in glucose or sodium chloride), 10% dextran 40 (in glucose or sodium chloride), sodium/potassium chloride (103mmol Na˖ and 51mmol K˖), sodium bicarbonate 1.39%, sodium chloride 0.9%, sodium lactate 1.72%, dextrose 5%, laevulose 20%, Ringer’s solution.
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