- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Gastro-resistant capsules containing 3mg budesonide.
Hepatitis-autoimmune: Induction of remission
Hepatitis-autoimmune: Maintenance of remission
Induction of remission:mild-moderate Crohn's disease (ileum &/or asc.colon)
Microscopic colitis: Induction of remission
Microscopic colitis: Maintenance of remission
9mg once daily in the morning or in divided doses three times a day (morning, midday and evening). Duration of treatment should be limited to 8 weeks.
Induction of remission: 9mg once daily in the morning. Duration of treatment should be limited to 8 weeks. Maintenance of remission: Maintenance therapy should only be initiated with frequently recurring symptoms of microscopic colitis after successful induction treatment. 6mg once daily in the morning or alternating between 6mg or 3mg once daily in the morning (average daily dose of 4.5mg budesonide) according to individual patient requirements. Maintenance therapy should be regularly evaluated during the first 12 months. Treatment should only be extended after 12 months if the benefits for the patient outweigh the risks.
Induction of remission: 3mg three times a day (morning, midday and evening).
Maintenance of remission: 3mg twice daily (morning and evening). If the transaminases ALT and/or AST increase during maintenance treatment, the dose should be increased to 3mg three times a day (morning, midday and evening). Duration of remission maintenance should be for at least 24 months.
The manufacturer does not give a dosage recommendation due to the limited data available for this age group.
Mild to moderate Crohn's disease affecting the ileum or ascending colon (unlicensed)
Children aged 12 to 18 years: 3mg three times a day for up to 8 weeks. The dose should be reduced for the last 2 weeks of treatment.
Additional Dosage Information
Do not stop this treatment abruptly but withdraw gradually by tapering doses. Gradual dose reduction over 2 weeks is recommended.
Children under 12 years
Uncontrolled systemic infection
Hereditary fructose intolerance
Precautions and Warnings
Children aged 12 to 18 years
Family history of diabetes mellitus
Family history of glaucoma
Transfer from other steroid therapy
Glucose-galactose malabsorption syndrome
History of steroid-induced psychosis
Administration of live vaccines is not recommended
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during periods of stress
Preparation contains sucrose
Clinical presentations of infections may be atypical
Diabetic control may need adjustment
If visual disturbances occur, perform ophthalmic evaluation
Antibody response to vaccines may be reduced
Patient should report worrying psychological changes esp. suicidal thoughts
May affect results of some laboratory tests
Avoid abrupt withdrawal
Withdraw gradually after long-term use
Advise patient grapefruit products may increase plasma level
Advise patient to avoid exposure to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Treatment with budesonide results in lower systemic steroid levels than conventional oral steroid therapy.
Transfer from other steroid therapy may result in symptoms related to the change in systemic steroid levels.
Systemic effects of corticosteroids such as Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely a wide range of psychiatric/behavioural effects may occur, particularly when prescribed at high doses and for prolonged periods.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. Deterioration of bacterial, fungal, amoebic, and viral infections during glucocorticoid treatment should be considered. Serious infections (such as septicaemia and tuberculosis) may be masked and reach an advanced stage before they are recognised.
Chickenpox may be fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster, and if exposed they should seek urgent medical attention. If the patient is a child, the parents must be given the above advice. Passive immunisation with varicella-zoster immunoglobulin is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. In some cases corticosteroids should not be stopped and the dose may need to be increased.
Patients with compromised immunity who have come into contact with measles should, wherever possible, receive normal immunoglobulin as soon as possible after exposure.
Corticosteroids may cause suppression of the hypothalamic pituitary adrenal axis (HPA axis) and reduce the stress response. Where patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended.
In patients with autoimmune hepatitis serum levels of transaminases (AST, ALT) should be evaluated at regular intervals to adapt the dose of budesonide adequately. During the first month of treatment, transaminase levels should be evaluated every two weeks, thereafter at least every three months.
Pregnancy and Lactation
Use budesonide with caution during pregnancy.
The manufacturer recommends that administration during pregnancy should be prescribed only when the expected benefits to mother and child outweigh the risks. It is unknown whether budesonide crosses the human placenta. The low molecular weight (about 431) and high lipid solubility predict substantial placental transfer. Administration of corticosteroids to pregnant animals may cause abnormalities of foetal development. The relevance of this to humans has not been established.
Use budesonide with caution during breastfeeding.
The manufacturer advises that budesonide given at the clinically recommended dose is anticipated to have minor effects on the breast-feeding child. Administration during breast-feeding mothers should be prescribed only when the expected benefits to mother and child outweigh the risks. Budesonide is excreted into breast milk. The low molecular weight (about 431) and the high lipid solubility predict substantial excretion of systemic budesonide into milk. However, when taken by mouth, budesonide is only 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breast milk.
Swallow whole with water. Do not chew.
Advise patient to take budesonide 3mg gastro-resistant capsules 30 to 60 minutes before food.
Advise patient to avoid the use of indigestion remedies 2 hours before or after budesonide 3mg gastro-resistant capsules.
Unless already immune, patients are at risk of severe chickenpox and should avoid close contact with people who have chickenpox or shingles. Similarly, precautions should also be taken against contracting measles. If exposed the patient should seek urgent medical advice.
Medical advice should be sought if worrying psychological changes occur.
Advise patients not to consume grapefruit products at the same time as budesonide.
Adrenal cortex insufficiency
Decreased glucose tolerance
Growth retardation (children)
Increased excretion of potassium
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased susceptibility to infection
Wound healing retarded
Effects on Laboratory Tests
ACTH stimulation test may show false results (lower values).
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2021
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Budenofalk 3mg gastro-resistant capsules. Dr. Falk Pharma UK Ltd. Revised December 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 August 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Budesonide. Last revised: 20 July 2020
Last accessed: 10 August 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.