Formulary
Budesonide: Indications, Dosing, Side Effects and Interactions
Budesonide is a glucocorticoid, which exerts significant local anti-inflammatory effects.
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Budesonide: Indications, Dosing, Side Effects and Interactions
Budesonide is a glucocorticoid, which exerts significant local anti-inflammatory effects.
Drug action
Budesonide is a glucocorticoid, which exerts significant local anti-inflammatory effects.
Indications and dose
**Prophylaxis of mild to moderate asthma (in patients stabilised on twice daily dose)**
- **Child** (By Inhalation Of Powder): 12-17 years 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
- **Adult** (By Inhalation Of Powder): 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
**Prophylaxis of asthma**
- **Adult** (By Inhalation Of Powder): 100-800 micrograms twice daily, dose to be adjusted as necessary.
**Microscopic colitis, induction of remission**
- **Adult** (By Mouth): 9 mg once daily for up to 8 weeks, to be taken in the morning, reduce dose gradually over 2 weeks following treatment course before stopping.
**Microscopic colitis, maintenance**
- **Adult** (By Mouth): 6 mg once daily, to be taken in the morning, alternatively 6 mg once daily and 3 mg once daily, to be taken on alternate mornings, review treatment regularly and no later than 12 months after initiation of maintenance treatment, treatment may be extended to beyond 12 months if required, when stopping treatment, reduce dose gradually over 2 weeks.
**Mild to moderate Crohn's disease affecting the ileum and/or ascending colon**
- **Adult** (By Mouth): 9 mg once daily for up to 8 weeks, to be taken in the morning, reduce dose gradually over 2 weeks following treatment course before stopping, alternatively 3 mg 3 times a day for up to 8 weeks, reduce dose gradually over 2 weeks following treatment course before stopping.
**Alternative in mild to moderate asthma,**
- **Adult** (By Inhalation Of Powder): for patients previously stabilised on a twice daily dose 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
**Treatment of mild-to-moderate acute ulcerative proctitis**
- **Adult** (By Rectum): 4 mg once daily for up to 8 weeks, to be administered at bedtime.
**Autoimmune hepatitis, induction of remission**
- **Adult** (By Mouth): 3 mg 3 times a day until remission is achieved, reduce dose gradually over 2 weeks following treatment course before stopping.
**Autoimmune hepatitis, maintenance**
- **Adult** (By Mouth): 3 mg twice daily for at least 24 months, when stopping treatment, reduce dose gradually over 2 weeks.
**Mild to moderate Crohn's disease affecting the ileum and/or ascending colon,Microscopic colitis, induction of remission**
- **Adult** (By Mouth): 9 mg once daily for up to 8 weeks, to be taken in the morning, reduce dose over 2 weeks by giving doses on alternate days following treatment course before stopping.
**Ulcerative colitis affecting sigmoid colon and rectum**
- **Adult** (By Rectum): 1 metered application once daily for up to 8 weeks.
**Induction of remission of mild to moderate active ulcerative colitis ,Induction of remission of active microscopic colitis**
- **Adult** (By Mouth): Induction of remission of mild to moderate active ulcerative colitis , Induction of remission of active microscopic colitis 9 mg once daily for up to 8 weeks, dose to be taken in the morning.
**Ulcerative colitis involving rectal and recto-sigmoid disease**
- **Adult** (By Rectum): 1 enema once daily for 4 weeks, to be administered at bedtime.
**Eosinophilic oesophagitis, induction of remission (initiated by a specialist)**
- **Adult** (By Mouth Using Orodispersible Tablet): 1 mg twice daily for 6 weeks; treatment may be extended to up to 12 weeks if required, to be taken after food.
**Eosinophilic oesophagitis, maintenance (initiated by a specialist)**
- **Adult** (By Mouth Using Orodispersible Tablet): 0.5 mg twice daily, to be taken after food, alternatively 1 mg twice daily, to be taken after food, use higher dose option for patients with long-term disease and/or with extensive oesophageal inflammation in the acute phase.
**Primary immunoglobulin A (IgA) nephropathy**
- **Adult** (By Mouth): 16 mg once daily for 9 months, to be taken in the morning; reduced to 8 mg once daily for 2 weeks, to be taken in the morning, dose to be reduced when stopping treatment, dose may be further reduced to 4 mg once daily for another 2 weeks if required.
**Bronchopulmonary dysplasia with spontaneous respiration for budesonide**
- **Neonate** (By inhalation of nebulised suspension): 500 micrograms twice daily.
- **Child 1-4 months** (By inhalation of nebulised suspension): 500 micrograms twice daily.
**Bronchopulmonary dysplasia with spontaneous respiration (severe symptoms) for budesonide**
- **Child 1-4 months (body-weight 2.5 kg and above)** (By inhalation of nebulised suspension): 1 mg twice daily.
**Prophylaxis of mild to moderate asthma (in patients stabilised on twice daily dose) for budesonide**
- **Child 6-11 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening.
- **Child 12-17 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
**Prophylaxis of asthma for budesonide**
- **Child 6-11 years** (By inhalation of powder): 100-400 micrograms twice daily, dose to be adjusted as necessary.
- **Child 12-17 years** (By inhalation of powder): 100-800 micrograms twice daily, dose to be adjusted as necessary.
- **Child 6 months-11 years** (By inhalation of nebulised suspension): 125-500 micrograms twice daily, dose adjusted according to response up to maximum 2 mg per day.
- **Child 12-17 years** (By inhalation of nebulised suspension): Initially 0.25-1 mg twice daily, dose adjusted according to response up to maximum 2 mg per day, doses higher than recommended max. may be used in severe disease.
**Prophylaxis and treatment of allergic rhinitis, Nasal polyps for budesonide**
- **Child 6-17 years** (By intranasal administration): 256 micrograms once daily, to be administered as 2 sprays into each nostril in the morning, reduce dose when control achieved, alternatively 128 micrograms twice daily, to be administered as 1 spray into each nostril in the morning and in the evening, reduce dose when control achieved.
**Mild to moderate Crohn's disease affecting the ileum and/or ascending colon for budesonide**
- **Child 12-17 years** (By mouth using modified-release capsules): 9 mg once daily for up to 8 weeks, to be taken in the morning, when stopping treatment, reduce dose for the last 2-4 weeks of therapy.
**Prophylaxis of asthma for Budelin Novolizer**
- **Child 6-11 years** (By inhalation of powder): 200-400 micrograms twice daily, dose to be adjusted as necessary.
- **Child 12-17 years** (By inhalation of powder): 200-800 micrograms twice daily, dose to be adjusted as necessary.
**Alternative in mild to moderate asthma, for patients previously stabilised on a twice daily dose for Budelin Novolizer**
- **Child 6-11 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening.
- **Child 12-17 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
**Mild to moderate Crohn's disease affecting the ileum and/or ascending colon for Budenofalk capsules**
- **Child 12-17 years** (By mouth): 3 mg 3 times a day for up to 8 weeks, reduce dose gradually over 2 weeks following treatment course before stopping.
**Ulcerative colitis involving rectal and recto-sigmoid disease for Entocort enema**
- **Child 12-17 years** (By rectum): 1 enema once daily for 4 weeks, to be administered at bedtime.
**Prophylaxis of asthma for Pulmicort Respules**
- **Child 3 months-11 years** (By inhalation of nebulised suspension): Initially 0.5-1 mg twice daily, reduced to 250-500 micrograms twice daily.
- **Child 12-17 years** (By inhalation of nebulised suspension): Initially 1-2 mg twice daily, reduced to 0.5-1 mg twice daily.
**Croup for Pulmicort Respules**
- **Child** (By inhalation of nebulised suspension): 2 mg for 1 dose, dose may be repeated every 12 hours until clinical improvement, alternatively 1 mg for 2 doses separated by a 30 minute interval, dose may be repeated every 12 hours until clinical improvement.
**Prophylaxis of asthma for Pulmicort Turbohaler**
- **Child 5-11 years** (By inhalation of powder): 100-400 micrograms twice daily, dose to be adjusted as necessary.
- **Child 12-17 years** (By inhalation of powder): 100-800 micrograms twice daily, dose to be adjusted as necessary.
**Alternative in mild to moderate asthma, for patients previously stabilised on a twice daily dose for Pulmicort Turbohaler**
- **Child 5-11 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening.
- **Child 12-17 years** (By inhalation of powder): 200-400 micrograms once daily, to be taken in the evening, increased if necessary up to 800 micrograms once daily, to be taken in the evening.
Cautions
For all corticosteroids (intranasal) Avoid after nasal surgery (until healing has occurred); avoid in pulmonary tuberculosis; avoid in the presence of untreated nasal infections; patients transferred from systemic corticosteroids may experience exacerbation of some symptoms Cautions, further information Systemic absorption Systemic absorption may follow nasal administration particularly if high doses are used or if treatment is prolonged; therefore also consider the cautions and side-effects of systemic corticosteroids. The risk of systemic effects may be greater with nasal drops than with nasal sprays; drops are administered incorrectly more often than sprays. Cautions For all corticosteroids (systemic) Congestive heart failure; diabetes mellitus (including a family history of); diverticular disease (increased risk of diverticular perforation); diverticulitis; epilepsy; glaucoma (including a family history of or susceptibility to); history of steroid myopathy; history of tuberculosis or X-ray changes (frequent monitoring required); hypertension; hypothyroidism; infection (particularly untreated); long-term use; myasthenia gravis; ocular herpes simplex (risk of corneal perforation); osteoporosis (in children); osteoporosis (postmenopausal women and the elderly at risk) (in adults); peptic ulcer; psychiatric reactions; recent intestinal anastomoses; recent myocardial infarction (rupture reported); severe affective disorders (particularly if history of steroid-induced psychosis); thromboembolic disorders; ulcerative colitis Cautions, further information With intra-articular use or intradermal use or intralesional use: For further information on cautions associated with intra-articular, intradermal, and intralesional preparations, consult product literature. Elderly In adults: Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: if used instead of inhaled corticosteroids for maintenance therapy in moderate to severe COPD (unnecessary exposure to long-term side-effects) as long-term (longer than 3 months) monotherapy for rheumatoid arthritis (risk of side-effects) for treatment of osteoarthritis other than for periodic intra-articular injections for monoarticular pain (risk of side-effects) with concurrent NSAIDs without proton pump inhibitor prophylaxis (increased risk of peptic ulcer disease)
Contraindications
For all corticosteroids (systemic) Avoid live virus vaccines in those receiving immunosuppressive doses (serum antibody response diminished); systemic infection (unless specific therapy given) Contra-indications, further information With intra-articular use or intradermal use or intralesional use: For further information on contra-indications associated with intra-articular, intradermal and intralesional preparations, consult product literature.
Side effects
For all corticosteroids (inhaled) Common or very common Headache; oral candidiasis; pneumonia (in patients with COPD); taste altered; voice alteration Uncommon Bronchospasm paradoxical; cataract; vision blurred Rare or very rare Adrenal suppression; anxiety; behaviour abnormal; glaucoma; growth retardation (in children); sleep disorder Side-effects, further information Systemic absorption may follow inhaled administration particularly if high doses are used or if treatment is prolonged. Therefore also consider the side-effects of systemic corticosteroids. Candidiasis The risk of oral candidiasis can be reduced by using a spacer device with the corticosteroid inhaler; rinsing the mouth with water after inhalation of a dose may also be helpful. An anti-fungal oral suspension or oral gel can be used to treat oral candidiasis without discontinuing corticosteroid therapy. Paradoxical bronchospasm The potential for paradoxical bronchospasm (calling for discontinuation and alternative therapy) should be borne in mind. Mild bronchospasm may be prevented by inhalation of a short-acting beta2 agonist beforehand (or by transfer from an aerosol inhalation to a dry powder inhalation). Side-effects For all corticosteroids (intranasal) Common or very common Altered smell sensation; epistaxis; headache; nasal complaints; taste altered; throat irritation Rare or very rare Glaucoma; nasal septum perforation (more common following nasal surgery); vision blurred Side-effects, further information Systemic absorption may follow nasal administration particularly if high doses are used or if treatment is prolonged. Therefore also consider the side-effects of systemic corticosteroids. Side-effects For all corticosteroids (systemic) Common or very common Anxiety; appetite increased; behaviour abnormal; cataract subcapsular; cognitive impairment; Cushing's syndrome; electrolyte imbalance; fluid retention; gastrointestinal discomfort; headache; healing impaired; hirsutism; hypertension; increased risk of infection; menstrual cycle irregularities; mood altered; nausea; osteoporosis; peptic ulcer; psychotic disorder; skin reactions; sleep disorder; vision blurred; weight increased Uncommon Adrenal suppression; alkalosis hypokalaemic; bone fractures; diabetic control impaired; glaucoma; haemorrhage; heart failure; hyperhidrosis; leucocytosis; myopathy; osteonecrosis; pancreatitis; papilloedema; seizure; thromboembolism; tuberculosis reactivation; vertigo Rare or very rare Tendon rupture Frequency not known Chorioretinopathy; eye disorders; growth retardation (very common in children); intracranial pressure increased with papilloedema (usually after withdrawal) Side-effects, further information Adrenal suppression During prolonged therapy with corticosteroids, particularly with systemic use, adrenal atrophy develops and can persist for years after stopping. Abrupt withdrawal after a prolonged period can lead to acute adrenal insufficiency, hypotension, or death. To compensate for a diminished adrenocortical response caused by prolonged corticosteroid treatment, any significant intercurrent illness, trauma, or surgical procedure requires a temporary increase in corticosteroid dose, or if already stopped, a temporary reintroduction of corticosteroid treatment. For vamorolone, there is no evidence on the effects of increasing the dose, and temporary supplementation with hydrocortisone is advised. Infections Prolonged courses of corticosteroids increase susceptibility to infections and severity of infections; clinical presentation of infections may also be atypical. Serious infections e.g. septicaemia and tuberculosis may reach an advanced stage before being recognised, and amoebiasis or strongyloidiasis may be activated or exacerbated (exclude before initiating a corticosteroid in those at risk or with suggestive symptoms). Fungal or viral ocular infections may also be exacerbated. Chickenpox Unless they have had chickenpox, patients receiving oral or parenteral corticosteroids for purposes other than replacement should be regarded as being at risk of severe chickenpox. Manifestations of fulminant illness include pneumonia, hepatitis and disseminated intravascular coagulation; rash is not necessarily a prominent feature. Passive immunisation with varicella-zoster immunoglobulin is needed for exposed non-immune patients receiving systemic corticosteroids or for those who have used them within the previous 3 months. Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be increased. Measles Patients taking corticosteroids should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed. Psychiatric reactions Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions including euphoria, insomnia, irritability, mood lability, suicidal thoughts, psychotic reactions, and behavioural disturbances. These reactions frequently subside on reducing the dose or discontinuing the corticosteroid but they may also require specific management. Patients should be advised to seek medical advice if psychiatric symptoms (especially depression and suicidal thoughts) occur and they should also be alert to the rare possibility of such reactions during withdrawal of corticosteroid treatment. Systemic corticosteroids should be prescribed with care in those predisposed to psychiatric reactions, including those who have previously suffered corticosteroid-induced psychosis, or who have a personal or family history of psychiatric disorders. When used by eye (topical) Vision disorders can occur with use of topical (eye) corticosteroids. Consider seeking specialist advice to evaluate cause if vision blurred or other vision disorder occurs. Side-effects For budesonide Common or very common When used by inhalation Cough; throat irritation With oral use Dry mouth (in adults); fatigue; insomnia (in adults); muscle complaints; oedema; oral disorders With rectal use Arthralgia (in adults); depression; gastrointestinal disorders; muscle complaints (in adults); muscle weakness (in adults) Uncommon When used by inhalation Muscle spasms; tremor With oral use Back pain (in adults); dizziness (in adults); flatulence (in adults) With rectal use Adrenal hypofunction (in adults); akathisia; altered smell sensation (in adults); asthenia (in adults); dizziness (in adults); flushing (in adults); insomnia; oral ulceration (in adults); paraesthesia (in adults) Rare or very rare When used by inhalation Akathisia With intranasal use Adrenal suppression With oral use Malaise With rectal use Constipation (in adults); increased risk of thrombosis (in adults); malaise (in adults) Side-effects, further information Systemic absorption can follow rectal administration, therefore also consider the side-effects of systemic corticosteroids.
Interactions
**Other interactions (6):**
- The metabolism of budesonide is primarily mediated by CYP3A enzymes.
- Co-treatment with CYP3A inhibitors, e.g.
- This is of limited clinical importance for short-term (1-2 weeks) treatment with itraconazole or ketoconazole or other potent CYP3A inhibitors, but should be taken into consideration during...
- If this medicine is co-administered with anti-fungals (such as itraconazole and ketoconazole), the period between treatments should be as long as possible.
- A reduction of the budesonide dose should be considered.
- Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also treated with oestrogens and contraceptive steroids, but no effect has been observed with this...
Pregnancy
For all corticosteroids (inhaled) Inhaled drugs for asthma can be taken as normal during pregnancy. Pregnancy For all corticosteroids (systemic) The benefit of treatment with corticosteroids during pregnancy outweighs the risk. Corticosteroid cover is required during labour. Following a review of the data on the safety of systemic corticosteroids used in pregnancy and breast-feeding the CSM (May 1998) concluded that corticosteroids vary in their ability to cross the placenta but there is no convincing evidence that systemic corticosteroids increase the incidence of congenital abnormalities such as cleft palate or lip. When administration is prolonged or repeated during pregnancy, systemic corticosteroids increase the risk of intra-uterine growth restriction; there is no evidence of intra-uterine growth restriction following short-term treatment (e.g. prophylactic treatment for neonatal respiratory distress syndrome). Any adrenal suppression in the neonate following prenatal exposure usually resolves spontaneously after birth and is rarely clinically important. Monitoring in pregnancy Pregnant women with pre-eclampsia or fluid retention should be monitored closely when given systemic corticosteroids.
Breast feeding
For all corticosteroids (inhaled) Inhaled corticosteroids for asthma can be taken as normal during breast-feeding. Breast feeding For all corticosteroids (systemic) The benefit of treatment with corticosteroids during breast-feeding outweighs the risk.
Hepatic impairment
For all corticosteroids (systemic) In general, manufacturers advise caution (risk of increased exposure). Hepatic impairment For budesonide For Budenofalk manufacturer advises avoid in cirrhosis (risk of increased exposure, limited information available). Hepatic impairment For Jorveza In adults: Manufacturer advises avoid (no information available).
Renal impairment
For all corticosteroids (systemic) In general, manufacturers advise caution. Renal impairment For Jorveza In adults: Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).
Medicinal forms
Tablet,Tablet,Capsule,Capsule,Granules,Powder,Suppository,Spray
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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