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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.
- Also comes is 25 micrograms vaginal tablet for induction of labour (every 6 hours until labour starts). These tablets are intended to be used by vaginal route only.