misoprostol: clinical use

Prescribing considerations

• Use only when induction is clinically indicated and in a hospital with trained obstetric personnel and continuous fetal and uterine monitoring available.
• Assess the cervix before administration.
• Evidence is limited in severe pre-eclampsia, prolonged membrane rupture, multiple pregnancy, grand multiparity, pregnancy before 37 weeks, a favourable cervix and patients younger than 18 years.
• Renal or hepatic impairment may increase exposure and requires product-specific prescribing review.

Contraindications and cautions

• Hypersensitivity to misoprostol or an excipient.
• Established labour or suspected fetal compromise before induction.
• Concurrent oxytocic or other labour-induction agents.
• Previous uterine or cervical surgery producing a suspected uterine scar, including caesarean birth.
• Uterine abnormality preventing vaginal delivery.
• Placenta praevia or unexplained vaginal bleeding after 24 weeks.
• Fetal malpresentation that contraindicates vaginal delivery.
• Severe kidney failure as defined in the product information.

Monitoring

• Continuously monitor uterine activity and fetal status.
• Assess for excessive or prolonged contractions and fetal heart-rate abnormalities.
• Review promptly if labour starts, fetal or maternal concern develops, or another induction agent is being considered.
• Remain alert to postpartum haemorrhage and the rare possibility of placental separation or uterine rupture.

Clinical pharmacology

Misoprostol is rapidly absorbed and converted to misoprostol acid, its active metabolite. Peak concentrations occur in about 30 minutes and the active metabolite has a short elimination half-life of about 45 minutes; inactive metabolites are excreted in urine.

Formulation and product differences

• The selected formulation is a white, uncoated oral tablet with a score line that is not intended for splitting.
• Other misoprostol-containing products may have different formulations, routes and licensed indications and should not be treated as automatically interchangeable.

Tablet

Route: Oral

Strengths: 25 micrograms, 200 micrograms