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Betamethasone sodium phosphate oral

Updated 2 Feb 2023 | Glucocorticoid therapy


Oral formulations of betamethasone.

Drugs List

  • betamethasone 500microgram soluble tablet sugar-free
  • Therapeutic Indications


    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.

    Immunosuppression in transplantation, sarcoidosis, polyarteritis nodosa.

    Unlicensed Uses

    Aphthous ulcers

    Oral ulceration


    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.


    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.


    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.


    Uncontrolled systemic infection

    Precautions and Warnings

    Children under 18 years
    Family history of diabetes mellitus
    Family history of glaucoma
    Congestive cardiac failure
    Diabetes mellitus
    Epileptic disorder
    Hepatic impairment
    History of severe affective disorders
    History of steroid myopathy
    History of steroid-induced psychosis
    History of tuberculosis
    Myasthenia gravis
    Ocular herpes simplex infection
    Peptic ulcer
    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


    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.


    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
    Acute pancreatitis
    Aggravation of schizophrenia
    Avascular osteonecrosis
    Behavioural disturbances
    Cognitive impairment
    Corneal thinning
    Cushing's syndrome
    Cushingoid facies
    Cutaneous atrophy
    Elevated serum LDL cholesterol
    Emotional lability
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Growth retardation (children)
    Hypersensitivity reactions including anaphylaxis
    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
    Menstrual disturbances
    Myocardial rupture
    Negative calcium balance
    Negative nitrogen balance
    Negative protein balance
    Oesophageal ulceration
    Peptic ulceration with perforation and haemorrhage
    Posterior subcapsular cataracts
    Potassium loss
    Proximal myopathy
    Psychological dependence
    Recurrence of dormant tuberculosis
    Reduced carbohydrate tolerance
    Scleral thinning
    Sleep disturbances
    Sodium/water retention
    Stevens-Johnson syndrome
    Suicidal tendencies
    Suppression of clinical signs of infection
    Suppression of the hypothalamic-pituitary-adrenal axis
    Tendon rupture
    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.


    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 ( ) or if this is unavailable at the backup site ( ).

    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:
    Last accessed: 16 July 2021

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