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Budesonide

Presentation

Gastro-resistant capsules containing 3mg budesonide.

Drugs List

  • BUDENOFALK 3mg gastro-resistant capsules
  • budesonide 3mg gastro-resistant capsules
  • Therapeutic Indications

    Uses

    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

    Dosage

    Adults

    Crohn's disease
    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.

    Microscopic colitis
    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.

    Autoimmune Hepatitis
    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.

    Children

    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.

    Contraindications

    Children under 12 years
    Uncontrolled systemic infection
    Galactosaemia
    Hepatic cirrhosis
    Hereditary fructose intolerance

    Precautions and Warnings

    Children aged 12 to 18 years
    Family history of diabetes mellitus
    Family history of glaucoma
    Infection
    Transfer from other steroid therapy
    Breastfeeding
    Cataract
    Diabetes mellitus
    Glaucoma
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of steroid-induced psychosis
    Hypertension
    Lactose intolerance
    Osteoporosis
    Peptic ulcer
    Pregnancy
    Psychiatric disorder

    Administration of live vaccines is not recommended
    May mask symptoms or signs of infections
    Systemic corticosteroids may be needed during periods of stress
    Contains lactose
    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

    Pregnancy

    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.

    Lactation

    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.

    Counselling

    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.

    Side Effects

    Abdominal pain
    Adrenal cortex insufficiency
    Aggression
    Amenorrhoea
    Anxiety
    Blurred vision
    Bone necrosis
    Cataracts
    Constipation
    Contact dermatitis
    Cushing's syndrome
    Decreased glucose tolerance
    Depression
    Diabetes mellitus
    Dizziness
    Duodenal ulcer
    Dyspepsia
    Ecchymosis
    Euphoria
    Exanthema
    Gastric ulceration
    Glaucoma
    Growth retardation (children)
    Headache
    Hirsutism
    Hyperacusis
    Hypertension
    Immune disorder
    Impotence
    Increased excretion of potassium
    Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
    Increased susceptibility to infection
    Irritability
    Malaise
    Moon face
    Muscle pain
    Muscle weakness
    Nausea
    Oedema
    Osteoporosis
    Pancreatitis
    Papilloedema
    Petechiae
    Psychomotor hyperactivity
    Sodium retention
    Steroid acne
    Striae
    Thrombosis
    Tiredness
    Truncal obesity
    Twitching
    Vasculitis
    Visual disturbances
    Vomiting
    Wound healing retarded

    Effects on Laboratory Tests

    ACTH stimulation test may show false results (lower values).

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: August 2021

    Reference Sources

    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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