Budesonide orodispersible tablet
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Orodispersible formulations of budesonide.
Drugs List
Therapeutic Indications
Uses
Eosinophilic oesophagitis
Dosage
Adults
Initial dose: 2mg daily, taken as two separate even doses (morning and evening).
The initial treatment duration is 6 weeks. This may be extended up to 12 weeks in patients who are not responding within 6 weeks.
Maintenance dose: 1mg to 2mg daily, taken as two separate even doses (morning and evening).
Contraindications
Children under 18 years
Uncontrolled systemic infection
Hepatic impairment
Severe renal impairment
Precautions and Warnings
Family history of diabetes mellitus
Family history of glaucoma
Breastfeeding
Cataract
Diabetes mellitus
Glaucoma
History of steroid-induced psychosis
Hypertension
Moderate renal impairment
Osteoporosis
Peptic ulcer
Pregnancy
Psychiatric disorder
Tuberculosis
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during periods of stress
Treatment to be initiated by specialist
Clinical presentations of infections may be atypical
If visual disturbances occur, perform ophthalmic evaluation
Antibody response to vaccines may be reduced
High doses may cause adrenal suppression/bone metabolism changes
Patient should report worrying psychological changes esp. suicidal thoughts
May affect results of some laboratory tests
Advise patient not to take St John's wort concurrently
Advise patient to avoid grapefruit products
Advise patient to avoid exposure to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Candidiasis of the mouth and throat should be treated with topical or systemic anti-fungal therapy, while continuing treatment with budesonide orodispersible tablets.
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.
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.
Pregnancy and Lactation
Pregnancy
Use Budesonide with caution during pregnancy.
The manufacturer advises the use of budesonide during pregnancy should only occur 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.
Lactation
Use Budesonide with caution during breastfeeding.
The manufacturer advises that a decision should be made on whether to discontinued breastfeeding or to discontinue treatment for the mother, after reviewing the benefits of breastfeeding for the child and the benefits of treatment for the mother. Budesonide is excreted into breast milk, however, only minor effects are anticipated for the breast-fed child following use at the clinically recommended dose.
Counselling
Take after a meal.
Advise patient to place the orodispersible tablet on the tip of the tongue and gently press it against the top of the mouth, where it will dissolve.
The orodispersible tablet should not be chewed or swallowed undissolved or taken with liquid or food.
Advise patient that there should be at least 30 minutes before eating or drinking or performing oral hygiene. Oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of the orodispersible tablet.
Advise patient to avoid exposure to chickenpox, herpes zoster and measles.
Advise patient to avoid grapefruit products.
Advise patient to report any signs of fungal infections in the mouth, throat and gullet such as white spots in the mouth and throat and difficulty swallowing.
Advise patient to report any visual disturbances.
Advise patient to report any psychological changes, especially suicidal thoughts.
Side Effects
Abdominal pain
Adrenal suppression
Aggression
Angioedema
Anxiety
Blurred vision
Cataracts
Central serous chorioretinopathy
Constipation
Contact dermatitis
Cough
Cushing's syndrome
Depression
Dizziness
Dry eyes
Dry throat
Duodenal ulcer
Dyspepsia
Dysphagia
Ecchymosis
Erosive gastritis
Euphoria
Exanthema
Fatigue
Gastric ulceration
Gastroesophageal reflux disease
Glaucoma
Glossodynia
Growth retardation (children)
Headache
Hyperglycaemia
Hypertension
Hypokalaemia
Increased susceptibility to infection
Irritability
Joint pain
Malaise
Muscle pain
Muscle twitch
Muscle weakness
Nausea
Oedema of the lips
Oesophageal candidiasis
Oral paraesthesia
Oropharyngeal candidiasis
Oropharyngeal pain
Osteonecrosis
Osteoporosis
Pancreatitis
Papilloedema
Petechiae
Pseudotumour cerebri
Psychomotor hyperactivity
Rash
Reduction in serum cortisol levels
Sensation of foreign body
Sleep disorders
Thrombosis
Upper abdominal pain
Urticaria
Vasculitis
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: October 2018
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: Jorveza 1mg orodispersible tablets. Dr. Falk Pharma UK Ltd. Revised January 2018.
Summary of Product Characteristics: Jorveza 0.5mg orodispersible tablets. Dr. Falk Pharma UK Ltd. Revised February 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 August 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: 20 July 2020
Last accessed: 18 August 2022
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