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Articles
Can mothers breastfeed after a medical termination of pregnancy?
30 October 2020This updated Medicines Q&A evaluates the available evidence for the safety of mifepristone and misoprostol in breast feeding women. Summary There will be occasions when…
Safety in Lactation: Drugs for disorders of gastric acid and ulceration
21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Drugs for dyspepsia Aluminium and magnesium…
Mifepristone + misoprostol
13 September 2020A synthetic analogue of Prostaglandin E1 (PGE1). 25microgram tablet formulation, taken as 25 micrograms every two hours or 50 micrograms every 4 hours
Medicine Compliance Aid Stability
CytotecPharmacia Ltd
Pharmacia Ltd
Cytotec
Tablets 200 micrograms
R1 · Red 1Stability data indicates that the drug is not suitable for CAs.
Unsuitable
Drug is moisture sensitive.
6 November 2015
Lactation Safety Information
For gastroprotection
For gastroprotection
-
Small amounts in breast milk
11 July 2016
For pregnancy termination
For pregnancy termination
Mifepristone
Unlicensed indication in the UK
Small amounts in breast milk after oral dosing are considered compatible
Low levels anticipated in milk from other administration routes
3 May 2018
New Medicines
Angusta Induction of labour
Information
Angusta
New formulation
Norgine
Not Known
Development and Regulatory status
Launched
Licensed but not launched
None
March 2021
Mar 21Angusta 25 microgram oral tablets available in the UK. Price for 8 tablets = £83.14 (hospital only)[5].
Sep 20Marketing Authorisation granted in the UK [4].
Aug 20Norgine announces completion of Repeat Use Procedure (RUP) in Austria, Belgium, Cyprus, Germany, Greece, Spain, Ireland, Italy, Luxemburg, Malta, Netherlands, Portugal and the United Kingdom [3].
Mar 20Azanta acquired by Norgine [3].
Dec 17Misoprostol granted marketing authorisation in 11 EU countries that include France, Latvia, Estonia, Poland, Romania, Bulgaria, Czech Republic, Slovakia, Hungary, Slovenia, Croatia. The marketing approval was via a mutual recognition procedure (MRP) [3].
Mar 17Azanta receives approval for 25µg tablets of misoprostol in Nordic countries (Denmark, Sweden, Norway, Finland and Iceland) [3].
Feb 16Azanta files for marketing authorisation of misoprostol tablets in Nordic countries via decentralised procedure [3].
Category
A synthetic analogue of Prostaglandin E1 (PGE1). 25microgram tablet formulation, taken as 25 micrograms every two hours or 50 micrograms every 4 hours
Induction is the process of starting labour by uterine stimulation. It should be used when it is thought that the baby will be safer delivered than it is in utero. Induction needs to be clearly distinguished from augmentation of labour, which is the enhancement of uterine contractions once labour has started. There has been an increase in the rate of inductions from 20.3% in 2006-7 to 29.4% in 2016-17 [1].
Induction of labour
Oral
Trial or other data
Aug 20Three trials have been conducted in support of the licence application. One took place in Australia (Dodd J, C Crowther, J Robinson. Oral misoprostol for induction of labour at term: randomised controlled trial. BMJ; 2006; 332(7540); 509-513 doi: 10.1136/bmj.38729.513819.63), one in North America (Bennett K, Butt K, Crane J, Hutchens D, Young D. A Masked Randomized Comparison of Oral and Vaginal Administration of Misoprostol for Labor Induction. Obstetrics & Gynecology; 1998; 92(4); 481-486) and one in Asia (Levy R, Vaisbuch E, Furman B, Brown D, Volach V, Hagay Z. Induction of labor with oral misoprostol for premature rupture of membranes at term in women with unfavorable cervix: a randomized, double-blind, placebo-controlled trial. Journal of Perinatal Medicine; 2007; 35; 126-129 DOI: 10.1515/JPM.2007.026) [2].