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Mifepristone and misoprostol oral and vaginal


1 oral tablet containing mifepristone and 4 vaginal tablets containing misoprostol.

Drugs List

  • mifepristone 200mg tablet and misoprostol 200microgram vaginal tablets
  • Therapeutic Indications


    Medical termination of pregnancy up to 63 days gestation



    Initial dose: 200mg of mifepristone taken orally.
    36 to 48 hours after initial dose: 800 micrograms of misoprostol administered vaginally as a single dose.


    The mifepristone tablet is taken in a single oral dose.

    Misoprostol vaginal tablets can be administered by a health care provider (place two tablets on each side of the cervix in vaginal vault) or by the woman herself.

    The woman should be instructed to clean her hands thoroughly, before inserting the misoprostol vaginal tablets as high as possible into the vagina, and remain recumbent for at least 30 minutes.


    Children under 18 years
    Suspected ectopic pregnancy
    Chronic adrenal failure
    Ectopic pregnancy
    Severe uncontrolled asthma

    Precautions and Warnings

    Risk factors for cardiovascular disorder
    Hepatic impairment
    Infective endocarditis
    Prosthetic heart valve
    Renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Anti-D immunoglobulin recommended for non immunised rhesus negative women
    Failed/incomplete abortion - therapy for complete evacuation must be given
    Only for use at approved centres under medical supervision
    Regional differences may exist in the law governing use of this product
    Remove intra-uterine device (IUD) before starting treatment
    Treat and control infections prior to commencing therapy
    Perform a complete physical and gynaecological examination before therapy
    Investigate persistent or recurrent vaginal bleeding
    Termination of pregnancy must be confirmed at follow-up visit
    Advise patient of potential side effects and risks associated with therapy
    Advise patient to inform doctor if vomiting occurs after administration
    Advise patient to report any abdominal or pelvic pain
    Vomiting or severe diarrhoea may impair efficacy
    Conception may occur before resumption of menses
    Patient must receive written info (including for heavy bleeding/emergency)
    Patients should be counselled regarding pregnancy after treatment complete

    Due to the antiglucocorticoid activity of mifepristone, the efficacy of long-term corticosteroid therapy including inhaled corticosteroids in asthmatic patients may be decreased during the three to four days following intake of mifepristone. Therapy should be adjusted accordingly.

    Clinicians should be aware of very rare reports of fatal toxic shock without fever or other symptoms of infection. These reports occurred when medical abortion was initiated with 200mg mifepristone followed by the non-authorised vaginal administration of misoprostol tablets for oral use.

    Pregnancy and Lactation


    This formulation of misoprostol is indicated only for termination of pregnancy.

    In animals, the abortifacient effect of mifepristone precludes the proper assessment of any teratogenic effect of the molecule. With subabortive doses, isolated cases of malformations observed in rabbits, but not in rats or mice were too few to be considered significant, or attributable to mifepristone.

    In humans, the few reported cases of malformations do not allow a causality assessment for mifepristone alone or associated to prostaglandin. Therefore, data is too limited to determine whether the molecule is a human teratogen. Consequently, women should be informed, that due to the risk of failure of the medical method of pregnancy termination and to the unknown risk to the foetus, the control visit is mandatory.

    Should a failure of the method be diagnosed at the control visit (viable ongoing pregnancy), and should the patient still agree, pregnancy termination should be completed by another method. Should the patient wish to continue with her pregnancy, the available data is too limited to justify a systematic termination of an exposed pregnancy. In that event, careful ultra-sonographic monitoring of the pregnancy should be carried out.

    Use in pregnancy has been associated with birth defects/malformations for ongoing pregnancies exposed to misoprostol and mifepristone or misoprostol alone. Prenatal exposure to misoprostol has been associated with Moebius syndrome and with amniotic band syndrome. Women considering medical termination of pregnancy should be precisely counselled on the risks to their foetus if an abortion failure occurs and a second termination of pregnancy procedure is not desirable.

    There is currently no relevant clinical data that suggest the possible occurrence of malformation after vaginal use of misoprostol during pregnancy. However, in a few cases where misoprostol was self-administered (orally or vaginally) in order to induce abortion, the following deleterious effects of misoprostol have been suggested: malformations of limbs, of foetus movements and of cranial nerves (hypomimia, abnormalities in suckling, deglutition, and eye movements). To date, a risk of malformations cannot be excluded.


    Mifepristone with misoprostol is contraindicated during breast-feeding.

    The manufacturer indicates that the use of mifepristone and misoprostol should be avoided during breastfeeding. Mifepristone is a lipophilic compound and may theoretically be excreted in the mother's breast milk. However, clinical data is limited.

    Low levels of misoprostol may be excreted in breast milk, adverse effects in breastfed infants are not expected.


    The treatment procedure should be fully explained and completely understood by the patient. A patient information leaflet should be made available appropriate to the indication.

    Inform patients of risks and requirements of procedure.

    The patient should be advised not to travel far away from the treatment centre until complete expulsion has been reported.

    The patient should be made aware of the importance of follow up visits and should be given precise instructions on whom she should contact and where to go in the event of any problems, particularly in the case of very heavy vaginal bleeding (This is bleeding that lasts longer than 12 days and/or that is heavier than normal menstrual bleeding).

    The patient should be advised to inform the doctor if she vomits or has diarrhoea shortly after administration of the mifepristone or misoprostol.

    Side Effects

    Epidermal necrolysis
    Erythema nodosum
    Hot flushes
    Hypersensitivity reactions
    Pelvic inflammatory disease
    Septic shock
    Uterine contractions
    Vaginal bleeding


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Medabon Combipack of Mifepristone 200 mg tablet and 4 x 0.2 mg vaginal tablets. Sun pharmaceutical industries Europe B.V. Revised June 2018.

    NICE Evidence Services Available at: Last accessed: 22 January 2020

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    'Mifepristone' Last revised: 03 December 2018
    'Misoprostol' Last revised: 31 October 2018
    Last accessed: 22 January 2020

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