Product overview

Drug action

Misoprostol is a synthetic analogue of prostaglandin E1, a naturally occurring oxytocic compound that softens the cervix and can stimulate uterine contractions.

Licensed therapeutic indication

The misoprostol vaginal delivery system (Mysodelle, Ferring Pharmaceuticals) is licensed for the induction of labour from 36 weeks' gestation in women with an unfavourable cervix in whom induction is clinically indicated. Contraindications include:

  • active labour

  • suspicion or evidence of fetal compromise before induction

  • fetal malpresentation

  • prior administration of oxytocic drugs or other labour induction agents

  • suspicion or evidence of uterine scarring from previous uterine or cervical surgery, for example, caesarean delivery.

See the summary of product characteristics for other contraindications, warnings and precautions for use.

The misoprostol vaginal delivery system is not currently marketed in the UK. The manufacturer has advised that the UK launch is expected in quarter 4, 2014 (Ferring Pharmaceuticals: personal communication, January 2014).

Course and cost

Mysodelle is a controlled-release vaginal delivery system that releases 200 micrograms of misoprostol at a rate of approximately 7 micrograms/hour over 24 hours. The maximum recommended dose is 1 vaginal delivery system (200 micrograms).

According to the summary of product characteristics, the misoprostol vaginal delivery system should be administered only by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring are available. The condition of the cervix should be assessed carefully before it is used. After insertion, uterine activity and fetal condition must be carefully monitored. The misoprostol vaginal delivery system should be removed at the onset of active labour; if uterine contractions are prolonged or excessive; if there is evidence of fetal compromise; or if 24 hours have elapsed since insertion. If the misoprostol vaginal delivery system falls out it should not be replaced.

The cost of the misoprostol vaginal delivery system has not yet been decided but is estimated to be £93.00 (Ferring Pharmaceuticals: personal communication, January 2014).