Budesonide
Published 28th December 2015, updated 11th February 2019
108622005
Articles
20th April 2017
Safety in Lactation: Drugs for obstructive airways disease
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Bronchodilators Most bronchodilators are considered to… Aclidinium bromide Aminophylline Bambuterol Beclometasone Budesonide Ciclesonide Ephedrine Fluticasone Formoterol Glycopyrronium Indacaterol Ipratropium Mepolizumab Mometasone Montelukast Nedocromil Obstetrics and gynaecology Olodaterol Omalizumab Paediatric and neonatal medicine Respiratory disorders Roflumilast Safety in Lactation Salbutamol Salmeterol Sodium cromoglicate Terbutaline Theophylline Tiotropium Umeclidinium bromide Umeclidinium bromide + Vilanterol Zafirlukast
3rd August 2016
Safety in lactation: Drugs for chronic bowel disorders
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine… Adalimumab Azathioprine Balsalazide Beclometasone Budesonide Ciclosporin Gastrointestinal disorders Golimumab Hydrocortisone Infliximab Mercaptopurine Mesalazine Methotrexate Obstetrics and gynaecology Olsalazine Paediatric and neonatal medicine Prednisolone Safety in Lactation Sulfasalazine Teduglutide Ustekinumab Vedolizumab
18th March 2016
IN USE PRODUCT SAFETY ASSESSMENT REPORT FOR Cortiment® 9mg prolonged release tablets (budesonide)
Cortiment® 9mg prolonged release tablets, manufactured by Ferring Pharmaceuticals, were launched in the UK in April 2015. UKMI has assessed this new product using the UKMI… Budesonide Gastrointestinal disorders Medicine New Medicines
25th February 2014
Which commonly used nebuliser solutions are compatible?
Mixing of nebuliser solutions should only be undertaken in the best interests of the patient and only by a person competent and willing to do… Budesonide Colistimethate Fluticasone Ipratropium Pharmaceutical Stability Q&A Respiratory disorders Salbutamol Salbutamol + Ipratropium Terbutaline Tobramycin
20th May 2012
Safety in Lactation: Corticosteroids
Fludrocortisone is used mainly for mineralocorticoid replacement in adrenocortical insufficiency. The other drugs in this group are used mainly for their anti-inflammatory, glucocorticoid activity, although… Beclometasone Betamethasone Budesonide Ciclesonide Deflazacort Dexamethasone Fludrocortisone Fluticasone Hydrocortisone Methylprednisolone Mometasone Prednisolone Prednisone Triamcinolone
20th May 2012
Safety in Lactation: Drugs used in nasal allergy
Drugs used for nasal allergy have limited systemic absorption in the mother, and pose negligible risk to a breastfed infant. There is no published evidence… Azelastine Beclometasone Betamethasone Budesonide Fluticasone Mometasone Sodium cromoglicate Triamcinolone acetonideMedicine Compliance Aid Stability
Entocort · AstraZeneca UK Ltd
AstraZeneca UK Ltd
Entocort
Capsules 3mg e/c m/r granules
A1 · Amber 1 · Stability data is available in an alternative container (not CAs) that may be extrapolated to support storage in CAs.
Airtight container
Protect from light
Protect from light and store in airtight containers. SPC states store in original packaging, which contains a desiccant. Company have stability studies that demonstrate stability in open storage for 3 months
22nd October 2015
Budenofalk · Dr Falk Pharma UK Ltd
Dr Falk Pharma UK Ltd
Budenofalk
Capsules 3mg e/c granules
A2 · Amber 2 · No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
Airtight container
Protect from light
Protect from light and store in airtight containers.
22nd October 2015
Lactation Safety Information
Inhalation
Inhalation
-
Limited published evidence of safety
Only negligible amounts in breast milk
Used in infants >1 month
21st April 2017
Intranasal
Intranasal
Oral/rectal for inflammatory bowel disease
Oral/rectal
for inflammatory bowel disease
-
No published evidence of safety after oral or rectal administration
Low levels anticipated in milk due to the drug’s properties
19th May 2016
New Medicines
Jorveza · Eosinophilic oesophagitis (new indication and formulation)
Information
Jorveza
New formulation
Dr Falk
Dr Falk
Development and Regulatory status
Launched
Launched
None
September 2018
Sep 18: Launched in the UK. Cost for 90 x 1mg orodispersible tablets =£323.00 [6].
Jan 18: Marketing authorisation granted throughout the EU [4]
Nov 17: CHMP recommends approval for treatment of the treatment of eosinophilic esophagitis in adults [3].
·Category
Glucocorticoid agonist in a orodispersible tablet formulation
In 2013, eosinophilic oesophagitis was considered to affect less than 5 in 10,000 people in the EU [1]. Studies suggest that the prevalence is rising, but it is uncertain whether this is a true increase or due to better diagnosis; it is most common in middle-aged men [5]. ·
Eosinophilic oesophagitis (new indication and formulation)
Oral
Further information
Yes
October 2019
Trial or other data
Dec 08: PIII BEE study (NCT00271349) completes. This study evaluated the efficacy and safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of 28 adult patients with active EE in Switzerland [2].
·Evidence based evaluations
Budenofalk · Lymphocytic colitis - first-line. EC-coated granule formulation.
Information
Budenofalk
Licence extension / variation
Dr Falk
Dr Falk
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Jan 17. Phase 3 study (NCT01209208) completed [6].
Dec 15. Launched in UK for Collagenous Colitis, which is a distinct form of microscopic colitis. The current license does not cover lymphocytic colitis [4].
May 14: Will be filed via the EU Mutual Recognition procedure [3].
·Category
Enteric coated granules containing the corticosteroid, budesonide
Microscopic colitis is characterised by chronic watery diarrhoea of unknown origin. Colonoscopy shows an essentially normal colonic mucosa, however abnormal histopathology on biopsy helps establish the correct diagnosis. Collagenous colitis and lymphocytic colitis are the two major subtypes. True incidence not known. ·
Lymphocytic colitis - first-line. EC-coated granule formulation.
Oral
Trial or other data
May 16: NCT01209208 study still recruiting patients. Expected to complete collection of primary outcome data in December 2016 [5].
Nov 13: PIII NCT01209208 study continue to recruit pts [1].
Mar 12: PIII NCT00217022 study is closed early, because of low enrollment [1].
May 10: PIII (NCT01209208) study to compare budesonide and mesalazine in the treatment of lymphocytic colitis begins. 75 pts will be recruited in Germany. Primary outcome is rate of clinical remission. Study is expected to complete in April 15 (primary outcome data collection complete in Dec 14) [1].
Aug 07: PIII NCT00180050 study completes. Approx 40 pts were recruited in Germany to assess whether budesonide is effective in the treatment of lymphocytic colitis. Primary outcome was proportion of patients in clinical remission after 6 weeks [1].
Jun 03: PII/III (NCT00217022) study begins recruiting pts in the US to assess efficacy and safety of budesonide compared with placebo for the treatment of diarrhoea in lymphocytic colitis. Primary outcome is satisfactory control of diarrhea during at least 3 of the last 4 weeks [1].
·Budenofalk · Collagenous colitis - maintenance of remission in adults
Information
Budenofalk
Licence extension / variation
Dr Falk
Development and Regulatory status
None
Phase III Clinical Trials
None
Category
Enteric coated granules containing the corticosteroid, budesonide
Microscopic colitis (MC) is a chronic inflammatory condition characterized by chronic diarrhea, normal colonic mucosa, and abnormal histologic hallmarks. Two distinct disease phenotypes exist, collagenous colitis (CC) and lymphocytic colitis (LC). Reported prevalence rates of CC and LC are 42 and 69 per 100,000 persons, respectively [1]. ·
Collagenous colitis - maintenance of remission in adults
Oral
Graft versus host disease (GvHD) in treatment resistant patients
Information
New formulation
Dr Falk
Dr Falk
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Category
Glucocorticoid receptor agonist. An oral rinse formulation that will be absorbed through the oral mucosa. This way, the product is expected to act locally, while its side effects are expected to be limited.
Immunosuppressed patients who receive white blood cells from another person are at risk of GVHD. There are approximately 25,000 HSCTs globally per year. Nearly 50% of these develop acute GVHD. There are no approved therapies for acute GVHD. Standard of care is corticosteroids as a first line agent. ·
Graft versus host disease (GvHD) in treatment resistant patients
Topical
Favolir (EU), Scipe (US) · Asthma in oral corticosteroid (OCS)-dependent (GINA Step 5) adults
Information
Favolir (EU), Scipe (US)
New formulation
Vectura
Vectura
Development and Regulatory status
Discontinued
Discontinued
Discontinued
Nov 18: Following the failure to meet primary endpoints in the PIII study, Vectura has decided to not pursue further the development of VR47.[7] ·
Category
Inhaled corticosteroid delivered to the lungs via AKITA jet inhalation system, controlled by a Smart Card.
5.4 million people in the UK are currently receiving treatment for asthma: 1.1 million children (1 in 11) and 4.3 million adults (1 in 12). Tthe UK has some of the highest rates of Asthma in Europe [3]. ·
Asthma in oral corticosteroid (OCS)-dependent (GINA Step 5) adults
Inhalation
Trial or other data
Nov 18: PIII study of VR475 in pts with severe uncontrolled asthma did not meet its primary endpoint. There was a trend in the reduction of the annual rate of exacerbations among pts receiving either VR475 1mg or 0.5mg BD over 52-weeks vs. placebo but results did not reach statistical significance. The open label arm with conventional nebuliser also failed to reach statistical significance vs. placebo.[7] ·
Eosinophilic oesophagitis
Information
New formulation
Shire
Shire
Development and Regulatory status
None
None
Phase III Clinical Trials
Yes
Category
Oral corticosteroid in an oral suspension that is designed to coat the oesophagus, enabling local anti-inflammatory action of the drug
Eosinophilic oesophagitis affects less than 5 in 10,000 people in the EU [1]. ·
Eosinophilic oesophagitis
Oral