Misoprostol oral 400 microgram
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing 400 micrograms misoprostol.
Drugs List
Therapeutic Indications
Uses
Medical termination of pregnancy up to 49 days gestation
Softening/dilatation of cervix before termination of pregnancy
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea.
Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester.
Unlicensed Uses
Medical termination of pregnancy up to 63 days gestation
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, at 50 to 63 days of gestation.
Dosage
It is recommended to take a new misoprostol 400 microgram tablet if vomiting occurs within 30 minutes after intake.
Adults
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of gestation
400 micrograms single dose
Taken 36 to 48 hours after taking a single 600mg oral dose of mifepristone.
Refer to product information for mifepristone.
Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester
400 micrograms single dose
Taken 3 to 4 hours before surgical operation.
Unlicensed Indication
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, at 50 to 63 days of gestation
800 micrograms single dose by buccal or sublingual administration.
Taken 24 to 48 hours after taking mifepristone.
Refer to product information for mifepristone.
Administration
For oral use.
Unlicensed routes of administration of sublingual and buccal can be considered depending on the indication being treated.
Contraindications
Suspected ectopic pregnancy
Acute renal failure
Breastfeeding
Chronic renal failure
Ectopic pregnancy
Hepatic failure
Malnutrition
Precautions and Warnings
Smokers over 35 years - increased risk of cardiovascular events
Anaemia
Cardiovascular disorder
Coagulopathy
Diabetes mellitus
Hyperlipidaemia
Anti-D immunoglobulin recommended for non immunised rhesus negative women
Failed/incomplete abortion - therapy for complete evacuation must be given
Not all routes are licensed for all indications
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
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
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
Pregnancy and Lactation
Pregnancy
This formulation of misoprostol is indicated only for termination of pregnancy.
Ongoing pregnancies exposed to misoprostol and mifepristone or misoprostol alone have been associated with birth defects and malformations. Also Moebius syndrome, amniotic band syndrome and central nervous system anomalies have been reported in prenatal exposure to misoprostol. The risk to the foetus in case of a failed abortion where a second termination attempt is not desirable should be clearly explained to women considering medical termination of pregnancy.
Lactation
Misoprostol is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking misoprostol due to potential presence in breast milk.
Diarrhoea has been reported in nursing infants exposed to misoprostol.
Side Effects
Abdominal cramps
Anaphylaxis
Angioedema
Arterial spasm
Back pain
Birth defects
Chills
Diarrhoea
Dizziness
Endometritis
Erythema nodosum
Erythroderma
Fever
Headache
Hot flushes
Hypersensitivity reactions
Hypotension
Malaise
Myocardial infarction
Nausea
Pelvic inflammatory disease
Rash
Septic shock
Toxic epidermal necrolysis
Urticaria
Uterine bleeding
Vaginal bleeding
Vomiting
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2021
Reference Sources
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: Topogyne 400 microgram Tablets. Nordic Pharmaceuticals Ltd. Revised December 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 December 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.