Budesonide
Published 28th December 2015, updated 11th April 2019
Articles
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 ZafirlukastSafety 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 VedolizumabIN 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 MedicinesWhich 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 TobramycinSafety 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 TriamcinoloneSafety 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
Budenofalk · Dr Falk Pharma UK Ltd
Lactation Safety Information
Inhalation
Intranasal
Oral/rectal for inflammatory bowel disease
New Medicines
Jorveza · Eosinophilic oesophagitis (new indication and formulation)
Information
Development and Regulatory status
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
Further information
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 · Collagenous colitis - maintenance of remission in adults
Information
Development and Regulatory status
Jan 19: Currently pre-registration in EU. Has been filed via the decentralised procedure [5].
Apr 17: Currently in PIII trials. Will be filed in the EU using the decentralised procedure [2].
·Category
Trial or other data
Sep 13: Dr Falk Pharma in collaboration with the Swedish Organization for Studies on Inflammatory Bowel Disease completed the PIII SOIBD Collagenous Colitis Maintenance Study (SCCMS) to investigate efficacy and tolerability of budesonide gastro-resistant granule in patients with microscopic colitis. Patients underwent an 8-week induction phase followed by maintenance treatment phase (NCT01278082). The trial enrolled 92 patients in Belgium, the Czech Republic, Denmark, Germany, Hungary and Sweden [2,4].
·Budenofalk · Lymphocytic colitis - induction of remission in adults, first-line (EC-coated granule formulation)
Information
Development and Regulatory status
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
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].
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