OXYTOCIN injectable

Prescription under medical supervision

Therapeutic action

– Synthetic oxytocic

Indications

– Induction and augmentation of labour in the event of dynamic dystocia
– Postpartum haemorrhage due to uterine atony
– Prevention of postpartum haemorrhage, after vaginal delivery or caesarean section

Forms and strengths, route of administration

– 10 IU in 1 ml ampoule (10 IU/ml) for IM or slow IV injection or infusion

Dosage

 Induction and augmentation of labour
Dilute 5 IU in 500 ml or 10 IU in 1 litre of Ringer lactate or 0.9% sodium chloride to obtain a solution of 10 milliunits per ml. Start an infusion of 5 drops/minute, then increase by 5 drops/minute every 30 minutes (max. 60 drops/minute) until efficient contractions are obtained (3 to 4 contractions lasting 40 seconds over 10 minutes).

– Treatment of postpartum haemorrhage due to uterine atony
20 IU in 1 litre of Ringer lactate or 0.9% sodium chloride, administered over 2 hours (160 drops/minute). Simultaneously, 5 to 10 IU by slow IV injection, to be repeated if necessary until the uterus is retracted (max. total dose 60 IU).

– Prevention of postpartum haemorrhage (vaginal delivery)
5 to 10 IU by slow IV or IM injection before or after the delivery of placenta

 Prevention of postpartum haemorrhage (caesarean section)
10 IU by slow IV injection after cord clamping, then 20 UI in 1 litre of Ringer lactate or 0.9% sodium chloride, administered over 2 hours (160 drops/minute).

Duration

– According to clinical response

Contra-indications, adverse effects, precautions

– Do not administer by rapid IV injection (risk of hypotension with flushing and reflex tachycardia, uterine hypertonia and/or rupture, foetal distress).
– During labour:
• Do not administer to patients with history of two caesarean sections or more.
• Administer with caution and do not exceed 30 drops/minute in patients with history of single caesarean section and in grand multipara (risk of uterine rupture).
• Respect the dosage and rate of administration, monitor uterine contractility and foetal heart rate.
– May cause: nausea, vomiting, heart rhythm disorders.
– Do not administer simultaneously with prostaglandins. Only administer oxytocin 6 hours after the last administration of prostaglandins.

Remarks

– Storage: to be kept refrigerated (2 °C to 8 °C). Do not freeze - 
• Expiry date indicated on the label is only valid if stored under refrigeration and protected from light. Exposure to light and heat causes the deterioration of the active ingredient and thus loss of efficacy.
• If refrigeration is not available, ampoules kept below 25 °C and protected from light may be s tored for a maximum of one month.