Oxytocin-BP

Oxytocinum

One millilitre of solution for injection (1 ampoule) contains oxytocin 5 IU.

Indication: Antepartum: induction or augmentation of labour for medical reasons (e.g. post-term pregnancy, premature rupture of membranes, pregnancy-induced hypertension, hypotonic uterine inertia) and as adjunctive therapy in incomplete/inevitable/missed abortion. Postpartum: during caesarean section after delivery of the baby; prevention and treatment of postpartum uterine atony and haemorrhage.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications). Caesarean section 1 ml of Oxytocin-BP 5 IU/ml given as an intravenous infusion (1.0 ml diluted in physiological sodium chloride solution and administered as an intravenous drip infusion or, preferably, using a variable-rate infusion pump over 5 minutes) after delivery of the baby. Prevention of postpartum haemorrhage: The usual dose is 5 IU by intravenous infusion (5 IU diluted in physiological electrolyte solution and administered as an intravenous drip infusion or, preferably, using a variable-rate infusion pump over 5 minutes) or 5-10 IU intramuscularly after delivery of the placenta. In women receiving Oxytocin-BP for induction or augmentation of labour, the infusion should be continued at an increased rate during the third stage of labour and for the following few hours. Treatment of postpartum haemorrhage 5 IU by intravenous infusion (5 IU diluted in physiological electrolyte solution and administered as an intravenous drip infusion or, preferably, using a variable-rate infusion pump over 5 minutes) or 5-10 IU intramuscularly, followed in severe cases by an intravenous infusion of a solution containing 5 to 20 IU of oxytocin diluted in 50 ml of electrolyte solution, at a rate necessary to control uterine atony. Incomplete, inevitable or missed abortion 5 IU by intravenous infusion (5 IU diluted in physiological electrolyte solution and administered as an intravenous drip infusion, or preferably, using a variable-rate infusion pump over 5 minutes), if necessary followed by an intravenous infusion at a rate of 20 to 40 milliunits/minute. If painful uterine contractions occur, the drip rate should be reduced or the infusion temporarily stopped. Route of administration Oxytocin-BP may be administered by only one route of administration, parenterally, either by intravenous infusion or intramuscularly. Oxytocin-BP must not be given as an intravenous bolus injection, as this may cause transient hypotension associated with facial flushing and reflex tachycardia. Special patient groups Elderly patients Use of Oxytocin-BP is not indicated in elderly patients. No studies have been performed in elderly patients (aged 65 years and over). Renal impairment No studies have been performed in patients with renal impairment. Caution is recommended in patients with severe renal impairment because of possible water retention and possible accumulation of oxytocin (see section

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties). Hepatic impairment No studies have been performed in patients with hepatic impairment. Pharmacokinetic alteration in patients with hepatic impairment is unlikely, since the metabolising enzyme oxytocinase is not limited to the liver alone, and placental oxytocinase levels increase significantly at term. Therefore, biotransformation of oxytocin in impaired hepatic function may not result in substantial changes in the metabolic clearance of oxytocin. Children and adolescents Use of Oxytocin-BP is not indicated in children and adolescents. 4.3 Contraindications − hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.; − severe cardiovascular disorders; − mechanical obstruction to delivery of the baby; − fetus in […]