Betamethasone sodium phosphate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of betamethasone.
Drugs List
Therapeutic Indications
Uses
Inflammatory or allergic conditions
Used in conditions where corticosteroid therapy may be necessary, for example:
Allergy and anaphylaxis
Bronchial asthma, severe hypersensitivity reactions, anaphylaxis.
Inflammatory skin disorders
Pemphigus vulgaris, bullous pemphigoid, pyoderma gangrenosum.
Rheumatic disorders
Rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease, rheumatic carditis.
Gastro-intestinal disorders
Ulcerative colitis, crohn's disease.
Renal disorders
Minimal change nephrotic syndrome, acute interstitial nephritis
Blood disorders
Haemolytic anaemia, leukaemia (acute lymphatic), malignant lymphoma, multiple myeloma, idopathic thrombocytopenia purpura.
Other
Immunosuppression in transplantation, sarcoidosis, polyarteritis nodosa.
Unlicensed Uses
Aphthous ulcers
Oral ulceration
Dosage
Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose, or a single morning dose on alternate days wherever possible. This is particularly important in children. Divided dosage may be employed and the lowest dose to produce an acceptable response should be administered.
Adults
Short term treatment: 2mg to 3mg daily for initial few days followed by a dose reduction of 250 micrograms or 500 micrograms every 2 to 5 days.
Rheumatoid arthritis: 500 micrograms to 2mg daily. Use lowest effective dose for maintenance.
Other conditions: 1.5mg to 5mg daily for 1 to 3 weeks, reduce to the lowest effective dose.
Mixed connective tissue disease and ulcerative colitis may require larger doses.
Oral ulceration (unlicensed): Dissolve one 500 microgram soluble tablet in 20ml of water and use as a mouthwash four times daily. Do not swallow.
Children
A proportion of the adult dose may be given, with due consideration to clinical factors. For example:
Children aged 12 years: 75% of adult dose.
Children aged 7 years: 50% of adult dose.
Children aged 1 year: 25% of adult dose.
Oral ulceration (unlicensed):
Children aged 12 to 18 years: Dissolve one 500 microgram soluble tablet in 20ml of water and use as a mouthwash four times daily. Do not swallow.
Additional Dosage Information
Withdrawing treatment
Patients receiving doses higher than the physiological dose of 1mg betamethasone for longer than 3 weeks should have dose withdrawn gradually. Dose reduction will depend on the likelihood of disease relapse during dose reduction and a clinical assessment of disease activity may be required. If unlikely for disease relapse but there is uncertainty of hypothalamic-pituitary-adrenal (HPA) suppression, dose may be reduced rapidly to 1mg betamethasone and then reduced slowly to allow HPA-axis recovery.
If relapse is unlikely and up to 6mg of betamethasone daily has been given for less than 3 weeks then abrupt withdrawal is unlikely to result in clinical relevant HPA-axis suppression in the majority of patients.
Even after less than 3 weeks of treatment, gradual withdrawal should be considered in the following patient groups:
-Patient on repeated courses of systemic corticosteroids, particularly if taken for longer than 3 weeks.
-A short course prescription within one year of stopping a course that lasted for months or years.
-Patients at risk of adrenocortical insufficiency other than exogenous corticosteroid therapy.
-Patients receiving systemic corticosteroid doses greater than 6mg daily of betamethasone.
-Patients taking repeated doses in the evening.
Contraindications
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Infection
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
Hepatic impairment
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Ulcerative colitis
Administration of live vaccines is not recommended
Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
Disease reactivation may occur in patients with latent TB
Exposure to measles may require prophylaxis with normal immunoglobulin
May mask symptoms or signs of infections
Contains sodium benzoate: may increase risk of jaundice in neonates
Passive immunisation of chicken pox / herpes zoster may be required
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood pressure regularly
Monitor regularly the height of children receiving prolonged treatment
Pregnancy: Monitor closely patients with pre-eclampsia or fluid retention
Prolonged or high dose may lead to adrenal suppression
Psychological changes may occur during initiation & withdrawal of treatment
Supervise patient closely during drug withdrawal
Adrenal cortical atrophy may persist for years after stopping drug
Advise patients/carers to seek medical advice if suicidal intent develops
Antibody response to vaccines may be reduced
Corticosteroids may cause growth retardation in children under 18 years
May cause activation of latent psychosis
May cause posterior subcapsular cataracts and glaucoma in long term use
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Potassium supplements may be required
Sudden withdrawal may be inadvisable -see product information/SPC
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
Dietary salt restriction may be necessary
Advise patient to avoid exposure to measles
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Ensure patient receives Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Patients (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chicken pox or herpes zoster and seek urgent medical attention if exposed as chicken pox can prove fatal in immunocompromised patients. If exposed while on betamethasone or within three months of previous use, passive immunisation with varicella/zoster immunoglobulin (VZIG) should be administered within 10 days of the exposure. If chicken pox occurs, treat urgently under specialist care. Do not stop betamethasone therapy, an upwards dosage adjustment may be required.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required especially during long term therapy.
Corticosteroids should not be used for the treatment of cerebral oedema associated with cerebrovascular accident or head injury, as they are unlikely to be of benefit and may cause harm.
Pregnancy and Lactation
Pregnancy
Use betamethasone with caution during pregnancy.
The manufacturer advises that is used only if the benefits to the mother and child outweigh the risks. However, if corticosteroids are considered essential, patients with normal pregnancies may be treated as though they were in the non-gravid state. Animal studies have shown that using betamethasone during pregnancy can caused foetal abnormalities such as cleft palate, intrauterine growth retardation and effects on brain growth and development.
Betamethasone readily crosses the placenta. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure but usually resolves spontaneously following birth and is rarely clinically important.
Betamethasone may result in transient suppression of foetal heart rate parameters and biophysical activities such as foetal breathing movements, body movements and heart rate. Closely monitor patients with pre-eclampsia or fluid retention.
Lactation
Use betamethasone with caution during breastfeeding.
The manufacturer advises that the presence of betamethasone in human breast milk is unknown but due to its molecular weight, transfer is expected. It is recommended to wait at least 3 to 4 hours after administration before breastfeeding (Schaefer, 2015). Infants of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.
Side Effects
Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Bruising
Candidiasis
Cognitive impairment
Confusion
Corneal thinning
Cushing's syndrome
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Dyspepsia
Elevated serum LDL cholesterol
Emotional lability
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Glaucoma
Growth retardation (children)
Hallucinations
Hiccups
Hirsutism
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Impaired healing
Increase in HDL cholesterol
Increased appetite
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Irritability
Leucocytosis
Malaise
Mania
Menstrual disturbances
Myocardial rupture
Nausea
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Oesophageal ulceration
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Psychological dependence
Psychosis
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Scleral thinning
Sleep disturbances
Sodium/water retention
Stevens-Johnson syndrome
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Vertebral and long bone fractures
Weight gain
Withdrawal syndrome - see product information
Withdrawal Symptoms and Signs
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A 'withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.
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: July 2021
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
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: Betamethasone 500 microgram soluble tablets. RPH Pharmaceuticals AB Ltd. Revised August 2020.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 16 July 2021
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.