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TOPOGYNE is a brand name for Misoprostol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea (see section 4.2). Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester. Misoprostol is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology • Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea: Misoprostol is taken as a single 400 microgram oral dose 36 to 48 hour after taking a single 600 mg oral dose of mifepristone.
Information on the posology of mifepristone can be found in the product information of mifepristone. Vomiting within 30 minutes after the intake could lead to a decrease in misoprostol efficacy: oral intake of a new misoprostol 400 microgram tablet is recommended in this case.
• Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester: Misoprostol is taken as a single 400 microgram oral dose 3 to 4 hours before surgical operation. Vomiting within 30 minutes after the intake could lead to a decrease in misoprostol efficacy: oral intake of a new misoprostol 400 microgram tablet is recommended in this case.
Paediatric population Only limited data are available on the use of misoprostol in adolescents. Method of administration Misoprostol tablets are for oral use only and should not be administered by any other route of administration.
The side effects of misoprostol are usually an extension of the pharmacological action and of the drug bioavailability. g. nausea, vomiting, diarrhoea and abdominal pain. 000) Not known (cannot be estimated from the available data) Infections and infestations Common: - Infection following abortion.
Suspected or confirmed infections (endometritis, pelvic inflammatory disease) have been reported in less than 5% of women. Very rare: - Very rare cases of serious or fatal toxic and septic shocks (caused by Clostridium sordellii or perfringens, Klebsiella pneumoniae, Escherichia coli, group A Streptococcus), which can be with or without fever or other obvious symptoms of infection, have been reported with the use of unauthorised vaginal or buccal administration of misoprostol tablets.
4. – Special warnings and special precautions for use). Immune system disorders Not known: - Anaphylaxis, hypersensitivity. Nervous system disorders Rare: - Headache. Vascular disorders Rare but serious cardiovascular accidents (cardiac arrest, myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported with the use of misoprostol tablets.
Gastrointestinal disorders Very common: - Nausea, vomiting, diarrhoea (these gastro-intestinal effects related to prostaglandin use are frequently reported). Common: - Cramping, light or moderate. 2%). Rare: - Single cases of urticaria, erythroderma, erythema nodosum, toxic epidermal necrolysis have also been reported.
Very rare: - Angioedema Musculoskeletal and connective tissue disorders Not known - Back pain. Reproductive system and breast disorders Very common: - Very common uterine contractions or cramping (10 to 45%) in the hours following misoprostol intake.
4% of the cases. Congenital, familial, and genetic disorders Common: - Foetal malformations Rare: - Foetal death General disorders and administration site conditions Rare: - Malaise, vagal symptoms (hot flushes, dizziness, chills), fever.
• In all instances Warnings Because of its abortifacient properties, misoprostol should never be used in a woman with an ongoing pregnancy who wants to complete it. An active involvement of the woman is required. The women should be informed of the method's requirements: - the need for a follow-up visit within 14 to 21 days after the start of the procedure in order to check for complete expulsion, Because of possible acute effects of misoprostol, women should be fully counselled regarding the likely signs and symptoms they may experience and have direct access to the treatment centre by telephone or local access.
Bleeding The patient must be informed of the occurrence of prolonged vaginal bleeding (an average of about 12 days or more) which may be heavy. She will receive precise instructions as to whom she should contact and where to go in the event of any problems emerging, particularly in the case of excessive vaginal bleeding.
This is bleeding that lasts longer than 12 days and/or that is heavier than the normal menstrual bleeding. Infection Serious cases (including fatal cases) of toxic shock and septic shock following infections with atypical pathogens (Clostridium sordellii and perfringens, Klebsiella pneumoniae, Escherichia coli, group A Streptococcus), have been reported with the medical abortion, performed with unauthorised vaginal or buccal administration of misoprostol tablets.
Clinicians should be aware of this potentially fatal complication. Due to presence of castor oil, there is a risk of sensitization. Teratogenicity Misoprostol MUST BE USED by oral route only: - after a previous administration of 600 mg mifepristone - Within the 36 – 48 hours interval after mifepristone intake Use of off label regimen enhances ALL risks related to the method Patients who decide to continue the pregnancy after treatment must be informed of the risk of teratogenicity.
2 Posology and method of administration is used. 6). A second termination of pregnancy procedure shall be considered. In case of continuation of the pregnancy close monitoring by ultrasound scan must be performed in specialised centres.
1. - Pregnancy not confirmed by ultrasound scan or biological tests. - Suspected ectopic pregnancy. For medical termination of pregnancy indication, in combination with mifepristone: - Pregnancy beyond 49 days of amenorrhea, - Contraindication for mifepristone.
When misoprostol is used in combination with mifepristone, please refer to the contraindications for this mifepristone as well. In the absence of specific studies, the misoprostol is not recommended for use in patients with: - Malnutrition - Hepatic failure - Renal failure Misoprostol MUST BE USED: - by oral route only - at a dose not higher than 400 micrograms
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Misoprostol in United Kingdom.
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Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Precautions for use Cardiovascular risk Rare but serious cardiovascular accidents (cardiac arrest, myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported following use of misoprostol.
g. age over 35 years with chronic smoking, hyperlipidemia, diabetes) or established cardiovascular disease should be treated with caution Contraception initiation after termination of pregnancy During clinical trials, new pregnancies occurred between embryo expulsion and the resumption of menses.
Therefore, when a termination of pregnancy conducted by medical procedure is medically confirmed, it is recommended to start contraception immediately. • Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea The precautions related to mifepristone should also be followed.
The age of the pregnancy must be determined from the questioning and the clinical examination of the patient. Uterine ultrasound is always recommended. Warnings In the case of a pregnancy occurring with an intra-uterine device in situ, this device must be removed before administration of mifepristone/misoprostol.
Risks related to the method:
The efficacy of the medical termination of pregnancy method decreases: - When the labelled regimen is not strictly applied, A follow-up visit must take place within a period of 14 to 21 days after the intake of mifepristone to verify by the appropriate means (clinical examination, together with beta-hCG measurement or ultrasound scan) that expulsion has been completed and that vaginal bleeding has stopped.
In case of persistent bleeding (even light) beyond the control visit, its disappearance should be checked within a few days. - With parity Failures The non-negligible risk of an on-going pregnancy occurs in 1% of the cases where the medical termination of pregnancy was within 49 days of amenorrhea and after oral administration.
This risk makes the follow-up visit mandatory in order to check that the expulsion is completed. In rare case of non-complete expulsion, a surgical revision may be necessary. Bleeding Bleeding occurs in almost all cases and is not in anyway a proof of complete expulsion.
The bleeding can occur very quickly after misoprostol intake, and sometimes later: - in 60%, expulsion occurs within 4 hours following misoprostol intake - in 40%, expulsion occurs within 24 to 72 hours following misoprostol intake.
Rarely the expulsion may occur before misoprostol administration (around 3% of cases). This does not preclude the control visit in order to check for the complete expulsion and the uterine vacuity. The patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been recorded.
Persistence of vaginal bleeding at this point could signify incomplete abortion, or an undiagnosed ectopic pregnancy, and appropriate treatment should be considered. 4% of the cases during the medical method of pregnancy termination, special care should be given to patients with haemostatic disorders with hypocoagulability, or with anaemia.
The decision to use the medical or the surgical method should be decided with specialised consultants according to the type of haemostatic disorder or the level of anaemia. In the event of an ongoing pregnancy diagnosed […]