AA Medical
Full Prescribing Info
Each 1 ml ampoule contains Oxytocin 10 i.u.
It is a sterile solution of Oxytocin in water for injection.
Oxytocin injection is used for the induction and augmentation of labour, to control postpartum bleeding and uterine hypotonicity in the third stage or labour, and to promote lactation in cases of faulty milk ejection. It is also used in missed abortions, but other measures may be preferred.
Dosage/Direction for Use
Administration: For the induction or augmentation of labour oxytocin injection may be given by slow intravenous infusion preferably by means of an infusion pump. A solution containing 5 unit in 500 mL of a physiological electrolyte such as 0.9% sodium chloride is generally recommended but more concentrated solutions may be given via infusion pump. For the treatment and prevention of postpartum haemorrhage oxytocin injection may be given by slow intravenous injection in a dose of 5 units; this may be followed in severe cases by intravenous infusion of 5 to 20 units in 500mL of a suitable non-hydrating diluent.
Special Precautions
Oxytocin should not be given where spontaneous labour or vaginal delivery are liable to harm either the mother or the fetus. This includes significant cephalopelvic disproportion or unfavourable presentation of the fetus, placenta praevia or vasa praevia cord presentation or prolapse, mechanical obstruction to delivery, fetal distress or hypertonic uterine contractions. It should not be used where there is a predisposition to uterine rupture, as in multiple pregnancy or high parity, polyhydramnios, or the presence of a uterine scar from previous caesarean section. Oxytocin should not be employed for prolonged periods in resistant uterine inertia, severe pre-eclampsia or severe cardiovascular disorders.
When given for induction or enhancement of labour particular care is needed in borderline cephalopelvic disproportion, less severe degrees of cardiovascular disease and in patients over 35 years of age or with other risk factors. Careful monitoring of fetal heart rate and uterine motility is essential so that dosage of oxytocin can be adjusted to individual response; the drug should be given by intravenous infusion, preferably by means of a syringe pump. Infusion should be discontinued immediately if fetal distress or uterine hyperactivity occur.
Over-vigorous labour should be avoided in cases of fetal death in utero, or where there is meconium-stained amniotic fluid.
The risk of water intoxication should be borne in mind, particularly when high doses of oxytocin are administered over a long time.
Adverse Reactions
Administration of oxytocin in high doses or to those hypersensitive to it may cause violent uterine contractions leading to uterine rupture and extensive laceration of the soft tissue, fetal bradycardia, fetal arrhythmias, and fetal asphyxiation, and perhaps fetal or maternal death.
Maternal deaths from severe hypertension and subarachnoid haemorrhage have occurred. Postpartum haemorrhage and fatal afibrinogenaemia have been reported but may be due to obstetric complications. Water retention leading to hyponatremia and intoxication, with pulmonary oedema, convulsions, coma, and even death may occur, especially when oxytocin is given intravenously over prolonged periods. Vasopressin-like activity is more likely with oxytocin of natural origin but may occur even with the synthetic peptide.
Anaphylactic and other hypersensitivity reactions, cardiac arrhythmias, pelvic haematomas, and nausea and vomiting may occur. Rapid intravenous injection has produced acute transient hypotension, together with flushing and reflex tachycardia.
There are reports of neonatal jaundice and retinal haemorrhage associated with the use of oxytocin in the management of labour. Adverse effects following the intranasal administration of oxytocin have included nasal irritation, rhinorrhoea, lachrymation, uterine bleeding, and violent uterine contractions.
Store in hermetic container below 25°C and protect from light.
MIMS Class
Drugs Acting on the Uterus
ATC Classification
H01BB02 - oxytocin ; Belongs to the class of oxytocin and analogues. Used in posterior pituitary lobe hormone preparations.
Soln for inj (amp) 10 IU/mL x 1's.
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