MISOPROSTOL oral

Prescription under medical supervision


Therapeutic action

– Oxytocic drug, prostaglandin analogue

Indications

– Incomplete abortion
– Termination of intra-uterine pregnancy, preferably in combination with mifepristone
– Induction of labour
– Treatment of post-partum haemorrhage due to uterine atony, when injectable oxytocics are not available or ineffective
– Cervical dilation before aspiration or curettage

Forms and strengths

– 25 micrograms and 200 micrograms tablets

Dosage and duration

– Incomplete abortion
• up to 13 weeks since the last menstrual period: 400 micrograms single dose sublingually or 600 micrograms single dose orally
• from 13 to 22 weeks since the last menstrual period: 400 micrograms sublingually every 3 hours

– Termination of pregnancy
• up to 13 weeks since the last menstrual period: 800 micrograms single dose sublingually or vaginally. If expulsion has not occurred within 24 hours administer a 2nd dose of 800 micrograms.
• from 13 to 22 weeks since the last menstrual period: 400 micrograms single dose sublingually or vaginally every 3 hours

 Induction of labour
25 micrograms orally every 2 hours, or if not possible, vaginally every 6 hours, until labour starts (max. 200 micrograms per 24 hours)

– Treatment of post-partum haemorrhage
800 micrograms single dose sublingually

– Cervical dilation before aspiration or curettage
400 micrograms single dose sublingually 1 to 3 hours before the procedure or vaginally 3 hours before the procedure

Contra-indications, adverse effects, precautions

– For induction of labour if the foetus is viable:
• Do not administer in the event of previous caesarean section.
• Administer with caution in case of grand multiparity or overdistention of the uterus (risk of uterine rupture).
• Monitor the intensity and frequency of contractions as well as foetal heart rate after administration of misoprostol.
• Do not administer simultaneously with oxytocin. At least 4 hours must have elapsed since the last administration of misoprostol before oxytocin can be given.
 For incomplete abortion or termination of pregnancy after 13 weeks since the last menstrual period: reduce the dose by half in the event of 2 or more previous caesarean sections.
– May cause: dose-dependent diarrhoea, vomiting, uterine hypertony, headache, fever, chills, foetal heart rhythm disorders, foetal distress.
– Breast-feeding: no contra-indication

Remarks

– Do not use misoprostol in ectopic or molar pregnancy.
– Rectal route is used for the treatment of post-partum haemorrhage when the sublingual route cannot be used.
– Storage: below 25 °C  -  -