MISOPROSTOL oral

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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.

    Storage

     
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    – Below 25 °C