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An oral choice
for induction
of labour

ANGUSTA® (misoprostol 25 μg):

An approved oral misoprostol treatment for the induction of labour

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Empowering women with the option of oral induction of labour

ANGUSTA® is an approved oral misoprostol treatment for the induction of labour1. ANGUSTA® is effective at inducing labour2 and clinical data supports the use of low dose oral misoprostol for the induction of labour3-6. ANGUSTA® has already been used for the induction of >100,000 women7.

When induction is needed, support her choice with the convenience and non-invasiveness of an oral induction.

Women prefer oral methods to vaginal ones for labour induction4,5,8

>

4

out
of

5

women who received oral misoprostol would use it again for future inductions (n=302)4

only

6

%

of women who received oral misoprostol would have preferred a Foley catheter (n=273)8

58.5

%

of women expressed a preference for an oral induction agent (n=741)5

Effective at inducing labour2–6

Previous clinical trials of oral misoprostol have shown it to be:

  • More effective than Foley catheter in an open-label, randomised controlled trial in the successful induction of a vaginal birth in 602 women with pre-eclampsia or hypertension (p=0.0136)4
  • More effective than placebo in improving PROM to delivery times in a double-blind randomised placebo controlled study in 130 patients (13.7h to 20.3h respectively p<0.05)3
  • Comparable and preferable to vaginal dinoprostone gel and Foley catheter, in previous clinical studies5,6,8

From an audit of the use of ANGUSTA® (25 µg misoprostol) in 976 women:2

85.1

%

of women had a vaginal delivery

38.8

%

of women gave birth within 24 hours

70.1

%

of women gave birth within 48 hours

WHO guidelines (2011) recommend 25 μg oral misoprostol 2-hourly as a method for induction of labour9

Pack and glass

Already used for the induction of >100,000 women7

The adverse event profile has been assessed in a compassionate use programme including >29,000 women.1

If required during labour, administration of oxytocin can start 4 hours after the last dose of ANGUSTA®.1 Breastfeeding can start 4 hours after the last dose of ANGUSTA®.1

Adverse events may include nausea, vomiting, meconium stain, postpartum haemorrhage, diarrhoea, uterine hyperstimulation, chills, pyrexia, low Apgar score and abnormal foetal heart rate.
For a full list of adverse reactions, details on precautions for use and contraindications, please refer to the ANGUSTA® Summary of Product Characteristics.

Flexible dosing

ANGUSTA® comes as ready-to-use oral tablets of 25 μg misoprostol.1 Two dosing options enable individualised treatment plans according to your hospital practice.1

The recommended maximum dose is 200 μg (8 tablets) over a period of 24 hours.1

Glass of water + 25 ug

1 tablet every 2 hours

OR

Glass of water + 50 ug

2 tablets every 4 hours

Support her personal choice and comfort with ANGUSTA®, an approved oral misoprostol for the induction of labour

REFERENCES

  1. ANGUSTA® UK Summary of Product Characteristics. September 2020.
  2. Helmig RB, Hvidman LE. Acta Obstet Gynecol Scand 2020; doi:10.1111/aogs.13876.
  3. Levy R et al. J Perinat Med 2007;35:126–129.
  4. Mundle S et al. Lancet 2017;390:669–680.
  5. Dodd JM et al. BMJ 2006;332:509–513.
  6. ten Eikelder ML et al. Lancet 2016;387:1619–1628.
  7. Data on File – Patient exposure to ANGUSTA®
  8. ten Eikelder ML et al. Am J Perinatol 2017;34:138–146.
  9. WHO recommendations for induction of labour. 2011.
PRESCRIBING INFORMATION CONTACT NORGINE TO FIND OUT MORE

Adverse events should be reported to your local regulatory agency, or in the UK Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to directly to Norgine Ltd by emailing GPharmacovigilance@norgine.com. By reporting side effects, you can help provide more information on this medicine.

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REFERENCES

  1. ANGUSTA® UK Summary of Product Characteristics. September 2020.
  2. Helmig RB, Hvidman LE. Acta Obstet Gynecol Scand 2020; doi:10.1111/aogs.13876.
  3. Levy R et al. J Perinat Med 2007;35:126–129.
  4. Mundle S et al. Lancet 2017;390:669–680.
  5. Dodd JM et al. BMJ 2006;332:509–513.
  6. ten Eikelder ML et al. Lancet 2016;387:1619–1628.
  7. Data on File – Patient exposure to ANGUSTA®
  8. ten Eikelder ML et al. Am J Perinatol 2017;34:138–146.
  9. WHO recommendations for induction of labour. 2011.