Drugs List

Therapeutic Indications

Uses

Induction of remission:mild-moderate Crohn's disease (ileum &/or asc.colon)
Microscopic colitis: Induction of remission
Microscopic colitis: Maintenance of remission
Ulcerative colitis: induction of remission

Contraindications

Children under 12 years
Uncontrolled systemic infection
Hepatic cirrhosis

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
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of steroid-induced psychosis
Hypertension
Lactose intolerance
Osteoporosis
Peptic ulcer
Pregnancy
Psychiatric disorder

May mask symptoms or signs of infections
Systemic corticosteroids may be needed during periods of stress
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
Some products may contain soya or soya derivative
Clinical presentations of infections may be atypical
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 not to take St John's wort concurrently
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 with higher systemic effect, may cause adrenocortical suppression. Monitoring of adrenocortical function should be considered and the dose of systemic glucocorticosteroid should be reduced cautiously.
Replacement of systemic glucocorticosteroid treatment with higher systemic effect with budesonide, sometimes unmasks allergies such as rhinitis and eczema which were previously controlled by the systemic drug.

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 carefully considered. Serious infection (such as septicaemia and tuberculosis) may be masked and reach an advanced stage before they are recognised.

Chickenpox may be fatal in immunocompromised patients. If exposed the patient should seek urgent medical advice. If the patient is a child, 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 chicken pox. If a diagnosis of chicken pox is confirmed, the illness warrants specialist care and urgent treatment. 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.

Some patients may feel unwell during the withdrawal phase e.g. pain in muscles and joints. If in rare cases, symptoms such as tiredness, headache, nausea and vomiting occur then a temporary increase in the dose of systemic glucocorticosteroids is sometimes necessary.

Administration of budesonide can lead to positive results in doping tests.

Pregnancy and Lactation

Pregnancy

Budesonide should be used with caution in pregnancy. 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, including intra-uterine growth retardation and skeletal anomalies.

Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Budesonide should be used with caution in breastfeeding. Budesonide given at the clinically recommended dose is unlikely to cause systemic effects in the infant.

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 about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Acne
Adrenal cortex insufficiency
Aggression
Amenorrhoea
Anaemia
Anaphylactic reaction
Anxiety
Behavioural disturbances
Blurred vision
Bone necrosis
Cataracts
Constipation
Contact dermatitis
Cushing's syndrome
Decreased glucose tolerance
Depression
Diabetes mellitus
Diarrhoea
Duodenal ulcer
Dyspepsia
Ecchymosis
Euphoria
Exanthema
Extremity pain
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hirsutism
Hypertension
Hypokalaemia
Immune disorder
Impotence
Increased excretion of potassium
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased susceptibility to infection
Influenza
Insomnia
Irritability
Malaise
Menstrual disturbances
Mood changes
Moon face
Muscle cramps
Muscle pain
Muscle weakness
Nausea
Nervousness
Oedema
Oedema of legs
Osteoporosis
Palpitations
Pancreatitis
Papilloedema
Peripheral oedema
Petechiae
Pruritus
Psychomotor hyperactivity
Sodium retention
Somnolence
Steroid acne
Stomach pain
Striae
Thrombosis
Tiredness
Tremor
Truncal obesity
Upper abdominal pain
Upper respiratory tract infection
Urticaria
Vasculitis
Visual disturbances
Wound healing retarded

Presentation

Oral formulations of budesonide.

Drugs List

Therapeutic Indications

Uses

Induction of remission:mild-moderate Crohn's disease (ileum &/or asc.colon)
Microscopic colitis: Induction of remission
Microscopic colitis: Maintenance of remission
Ulcerative colitis: induction of remission

Dosage

Adults

Children

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Children under 12 years
Uncontrolled systemic infection
Hepatic cirrhosis

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
Galactosaemia
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of steroid-induced psychosis
Hypertension
Lactose intolerance
Osteoporosis
Peptic ulcer
Pregnancy
Psychiatric disorder

May mask symptoms or signs of infections
Systemic corticosteroids may be needed during periods of stress
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Some formulations contain sucrose
Some products may contain soya or soya derivative
Clinical presentations of infections may be atypical
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 not to take St John's wort concurrently
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 with higher systemic effect, may cause adrenocortical suppression. Monitoring of adrenocortical function should be considered and the dose of systemic glucocorticosteroid should be reduced cautiously.
Replacement of systemic glucocorticosteroid treatment with higher systemic effect with budesonide, sometimes unmasks allergies such as rhinitis and eczema which were previously controlled by the systemic drug.

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 carefully considered. Serious infection (such as septicaemia and tuberculosis) may be masked and reach an advanced stage before they are recognised.

Chickenpox may be fatal in immunocompromised patients. If exposed the patient should seek urgent medical advice. If the patient is a child, 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 chicken pox. If a diagnosis of chicken pox is confirmed, the illness warrants specialist care and urgent treatment. 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.

Some patients may feel unwell during the withdrawal phase e.g. pain in muscles and joints. If in rare cases, symptoms such as tiredness, headache, nausea and vomiting occur then a temporary increase in the dose of systemic glucocorticosteroids is sometimes necessary.

Administration of budesonide can lead to positive results in doping tests.

Pregnancy and Lactation

Pregnancy

Budesonide should be used with caution in pregnancy. 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, including intra-uterine growth retardation and skeletal anomalies.

Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Budesonide should be used with caution in breastfeeding. Budesonide given at the clinically recommended dose is unlikely to cause systemic effects in the infant.

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 about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Swallow whole with water. Do not chew.

The granules should be taken about half an hour before breakfast.

Side Effects

Abdominal distension
Acne
Adrenal cortex insufficiency
Aggression
Amenorrhoea
Anaemia
Anaphylactic reaction
Anxiety
Behavioural disturbances
Blurred vision
Bone necrosis
Cataracts
Constipation
Contact dermatitis
Cushing's syndrome
Decreased glucose tolerance
Depression
Diabetes mellitus
Diarrhoea
Duodenal ulcer
Dyspepsia
Ecchymosis
Euphoria
Exanthema
Extremity pain
Fatigue
Glaucoma
Growth retardation (children)
Headache
Hirsutism
Hypertension
Hypokalaemia
Immune disorder
Impotence
Increased excretion of potassium
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased susceptibility to infection
Influenza
Insomnia
Irritability
Malaise
Menstrual disturbances
Mood changes
Moon face
Muscle cramps
Muscle pain
Muscle weakness
Nausea
Nervousness
Oedema
Oedema of legs
Osteoporosis
Palpitations
Pancreatitis
Papilloedema
Peripheral oedema
Petechiae
Pruritus
Psychomotor hyperactivity
Sodium retention
Somnolence
Steroid acne
Stomach pain
Striae
Thrombosis
Tiredness
Tremor
Truncal obesity
Upper abdominal pain
Upper respiratory tract infection
Urticaria
Vasculitis
Visual disturbances
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: March 2015.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Cortiment 9mg, prolonged release tablets. Ferring Pharmaceuticals Ltd. Revised November 2020.

Summary of Product Characteristics: Entocort CR 3mg capsules. Tillotts Pharma UK Limited. Revised October 2019.

Summary of Product Characteristics: Budenofalk 9mg gastro-resistant granules. Dr. Falk Pharma UK Ltd. Revised November 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 September 2022

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Budesonide. Last revised: 01 April 2014
Last accessed: 19 March 2015