Anti-progestogen + prostaglandin (medical abortion) Pregnancy: §4.6: used to terminate pregnancy. Data are too limited to determine whether mifepristone is a human teratogen; animal studies have not shown teratogenicity of misoprostol but have shown foetotoxicity at high doses. Failure of termination (continuing pregnancy) has been associated with a 3-fold increased risk of birth defects/malformations compared with controls (about 2%); prenatal misoprostol exposure has been associated with Moebius syndrome, amniotic band syndrome and central nervous system anomalies. Women must be counselled on the risk to the foetus if the abortion fails, the follow-up visit is mandatory, and if the patient wishes to continue the pregnancy careful ultrasound monitoring in a specialised centre must be established. Breast-feeding: avoid — mifepristone is lipophilic and may theoretically be excreted in breast milk, but no data are available.

Mifepristone and misoprostol (combination pack)

Brand names: Mifegyne + Topogyne, MTPak

This is a combination pack pairing the antiprogestogen mifepristone with the prostaglandin analogue misoprostol, used sequentially for medical termination of pregnancy and management of miscarriage.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Mifepristone 200 mg (one tablet) as a single oral dose, followed 36 to 48 hours later by misoprostol 800 micrograms (4 vaginal tablets of 0.2 mg each) administered vaginally as a single dose

Route: Mifepristone oral; misoprostol vaginal

Frequency: Single course — one oral mifepristone dose, then one vaginal misoprostol dose 36-48 hours later

Source: UK SPC for Medabon combipack (mifepristone 200 mg tablet + 4 x misoprostol 0.2 mg vaginal tablets), §4.2. Licensed only up to 63 days of amenorrhoea — pregnancy beyond 63 days is a contraindication (§4.3), as is pregnancy not confirmed by gynaecological examination, ultrasound scan or biological tests. If the patient vomits shortly after administration of mifepristone she should inform the doctor. Method of administration: the misoprostol vaginal tablets can be placed by a healthcare provider (two tablets on each side of the cervix in the vaginal vault) or inserted by the woman herself as high as possible into the vagina after thoroughly cleaning her hands, remaining recumbent for at least 30 minutes. A follow-up visit within 14-21 days after mifepristone intake is mandatory to check that abortion is complete; the method fails in 4.5-7.8% of cases and surgical treatment may be required. Expulsion of the products of conception may occur before misoprostol administration in 1-2% of cases (does not remove the need for the follow-up visit). Any intra-uterine device in situ must be removed before mifepristone is given. Caution (in the absence of specific studies) in renal failure, hepatic failure and malnutrition; patients with prosthetic heart valves or a previous episode of infective endocarditis should receive appropriate prophylactic antibiotics. Treatment should only be carried out where the patient has access to facilities equipped for surgical treatment of incomplete abortion, emergency blood transfusion and resuscitation. Before use in a woman who has undergone female genital mutilation, a physical examination must be performed by a qualified trained professional to exclude anatomical obstacles to medical abortion. Medabon has only been studied in women over age 18; the product is not evaluated for use in children and adolescents (§4.2, paediatric population). Retreatment with mifepristone is not recommended in patients who experience severe cutaneous adverse reactions.

Dose adjustments

Renal

No dose adjustment is stated; §4.4 advises caution, in the absence of specific studies, when use is considered in patients with renal failure.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Pregnancy not confirmed by gynaecological examination, ultrasound scan or biological tests
Pregnancy beyond 63 days of amenorrhoea
Confirmed or suspected extra-uterine (ectopic) pregnancy
Previous known allergy to prostaglandins
Severe asthma uncontrolled by therapy
Inherited porphyria
Chronic adrenal failure
Hypersensitivity to the active substances or to any of the excipients

Side effects

Uterine contractions or cramping — very common, up to 70-80% in the hours following misoprostol
Nausea, vomiting, diarrhoea and light-to-moderate cramping (common; the gastrointestinal effects are related to misoprostol)
Heavy bleeding in up to 5% of cases, which may require haemostatic curettage and blood transfusion in up to 1.8%; prolonged vaginal bleeding averaging about 13 days
Infection following abortion (endometritis, pelvic inflammatory disease) in under 1% of women; very rare fatal toxic shock from Clostridium sordellii endometritis presenting without fever
Foetal malformations (common) if the method fails and the pregnancy continues
Rare: hypotension, headache, malaise, vagal symptoms (hot flushes, dizziness, chills), fever, uterine rupture, urticaria/erythroderma/erythema nodosum/epidermal necrolysis; not known: coronary arteriospasm, myocardial infarction and cardiac arrest (mainly in women with cardiovascular risk factors), acute generalised exanthematous pustulosis

Interactions

§4.5 (interaction with other medicinal products) was NOT captured in the fetched SPC bundle — clinician to check the Medabon SPC §4.5 before sign-off

Clinical monograph

How it works

Mifepristone blocks progesterone receptors, sensitising the myometrium and softening the cervix, after which misoprostol stimulates uterine contractions and cervical ripening to complete expulsion.

Prescribing in practice

Mifepristone is taken first and misoprostol after an interval; warn that significant bleeding and cramping are expected and that the woman must have access to urgent care for haemorrhage or signs of incomplete or continuing pregnancy.
It should be used within an appropriate provider framework with confirmation of gestation and exclusion of contraindications such as suspected ectopic pregnancy, an in-situ intrauterine device, chronic adrenal failure or severe uncontrolled asthma.
If the pregnancy continues after exposure there is a recognised risk of fetal harm, so treatment failure must be actively followed up.

Monitoring

Confirm successful completion clinically or with follow-up testing, and assess bleeding, pain and any signs of infection or retained products.

Counselling the patient

Take the mifepristone first, then the misoprostol after the interval your clinician specifies.
Heavy bleeding and cramping are expected; seek urgent help for very heavy bleeding, fever, severe pain or feeling faint.
Attend any follow-up to confirm the process is complete, and start contraception when advised.

Evidence & guidelines

Sequential mifepristone followed by misoprostol is the regimen recommended by NICE and the RCOG for medical termination and miscarriage management.

Reference: RCOG / NICE NG140; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways