Dexamethasone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing dexamethasone.
Drugs List
Therapeutic Indications
Uses
Adrenocortical insufficiency
Chemotherapy induced nausea and vomiting
Congenital adrenal hyperplasia
Coronavirus disease 2019 (COVID-19) - treatment
Croup (acute laryngotracheobronchitis)
Diagnostic test for adrenocortical function
Inflammatory or allergic conditions
Raised intracranial pressure secondary to cerebral tumour
Tuberculous meningitis (with appropriate anti-TB chemotherapy)
Endocrine disorders
Primary or secondary adrenocortical insufficiency.
Congenital adrenocortical hyperplasia.
Endocrine exophthalmos.
Diagnostic testing of adrenocortical hyperfunction.
Non-endocrine disorders
Dexamethasone has been used for suppression of inflammatory and allergic disorders in the treatment of a range of non-endocrine corticosteroid responsive conditions.
Allergy and anaphylaxis
Anaphylaxis.
Arteritis collagenosis
Polymyalgia rheumatica, polyarteritis nodosa.
Haematological disorders
Haemolytic anaemia (also autoimmune), leukaemia, myeloma, idiopathic thrombocytopenic purpura in adults, reticulolymphoproliferative disorders.
Infectology
Tuberculosis meningitis only in conjunction with anti-infective therapy.
Gastroenterological disorders
For treatment in the critical stage in: ulcerative colitis (rectal only); Crohn's disease; certain forms of hepatitis.
Muscular disorders
Polymyositis.
Neurological disorders
Raised intracranial pressure secondary to cerebral tumours, acute exacerbations of multiple sclerosis.
Ocular disorders
Anterior and posterior uveitis, optic neuritis, chorioretinitis, iridocyclitis, temporal arteritis, orbital pseudotumour.
Renal disorders
Nephrotic syndrome.
Pulmonary disorders
Chronic bronchial asthma, acute asthma, aspiration pneumonitis, chronic obstructive pulmonary disease (COPD), sarcoidosis, allergic pulmonary disease such as farmer's and pigeon breeder's lung, Loffler's syndrome, cryptogenic fibrosing alveolitis.
Rheumatic disorders
Some cases or specific forms (Felty's syndrome, Sjorgen's syndrome) of rheumatoid arthritis, including juvenile rheumatoid arthritis, acute rheumatism, lupus erythematosus disseminatus, temporal arteritis (polymyalgia rheumatica).
Skin disorders
Pemphigus vulgaris, bullous pemphigoid, erythrodermas, serious forms of erythema multiforme (Stevens-Johnson syndrome), mycosis fungoides, bullous dermatitis herpetiformis.
Oncological disorders
Lymphatic leukaemia, especially acute forms, malignant lymphoma (Hodgkin's disease, non-Hodgkin's lymphoma), metastasized breast cancer, hypercalcaemia as a result of bone metastasis or Kahler's disease, palliative treatment of neoplastic diseases.
Coronavirus disease 2019 (COVID-19)
Treatment of COVID-19 in adult and adolescent patients who require supplemental oxygen therapy.
Other
Intense allergic reactions; as immunosuppressants in organ transplantation; as an adjuvant in the prevention of nausea and vomiting and in the treatment of cancer with oncolytics that have a serious emetic effect; as an adjuvant in the treatment and prevention of postoperative vomiting.
Dosage
Individualise the dosage on the basis of the disease and the response of the patient. To minimise the risk of any side effects always use the lowest possible dosage adequate to control the disease process.
Adults
The initial dosage varies from 500 micrograms to 10mg daily depending on the disease being treated. In more severe diseases, higher dosages may be temporarily required to control the disease. Once the disease is under control the dosage should be reduced or tapered off to the lowest suitable level under continuous monitoring and observation of the patient.
Chronic dosage should preferably not exceed 1.5mg dexamethasone daily.
Both the evening dose (which is useful in alleviating morning stiffness in some conditions), and the divided dosage regimen are associated with greater suppression of the hypothalamus-pituitary-adrenal axis.
If satisfactory clinical response does not occur after a reasonable period of time, discontinue treatment and transfer the patient to other therapy.
In acute, self-limiting allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:
First day: dexamethasone injection 4mg to 8mg intramuscularly.
Second day: 1mg dexamethasone twice daily.
Third day: 1mg dexamethasone twice daily.
Fourth day: 500 micrograms dexamethasone twice daily.
Fifth day: 500 micrograms dexamethasone twice daily.
Sixth day: 500 micrograms dexamethasone once daily.
Seventh day: 500 micrograms dexamethasone once daily.
Eighth day: Re-assessment.
Dexamethasone suppression tests
Test for Cushing's syndrome:
1mg to 2mg dexamethasone should be administered orally at 11 pm. Blood samples are then taken at 8 am the following morning for plasma cortisol determination. For greater accuracy, 500micrograms dexamethasone should be administered every 6 hours for 48 hours. Blood samples should be drawn at 8 am on the third morning for plasma cortisol determination. 24-hour urine collections should be employed for determination of 17-hydroxycorticosteroid excretion.
Test to distinguish Cushing's syndrome caused by pituitary ACTH excess from the syndrome induced by other causes:
2mg dexamethasone administered orally every 6 hours for 48 hours. Blood should be drawn at 8 am on the third morning for plasma cortisol measurement. 24-hour urine collections should be employed for determination of 17-hydroxycorticosteroid excretion.
Chemotherapy induced nausea and vomiting
Prevention of acute symptoms: 4mg to 20mg immediately before chemotherapy.
Prevention of delayed symptoms:8mg twice daily for two to four days.
Raised intracranial pressure
Initial therapy is usually given by injection. Maintenance oral dose 2mg two to three times a day may be effective. Depending on the cause and severity, 2mg to 4mg three to four times daily may be necessary (up to 24mg daily dose).
Acute asthma: 16mg daily for 2 days.
Acute skin diseases
8mg to 40mg daily depending on severity, in some cases up to 100mg may be required, which should be followed by down titration according to clinical need.
Systemic lupus erythematosus: 6mg to 16mg daily.
Active rheumatoid arthritis
Fast destructive forms: 12mg to 16mg daily.
Extra-articular manifestations: 6mg to 12mg daily.
Idiopathic thrombocytopenia purpura: 40mg for four days in cycles.
Tuberculosis meningitis
Grade 2 or 3
Week 1: 400 micrograms per kg per day intravenously.
Week 2: 300 micrograms per kg per day intravenously.
Week 3: 200 micrograms per kg per day intravenously.
Week 4: 100 micrograms per kg per day intravenously.
Week 5: 4mg per day orally.
Week 6: 3mg per day orally.
Week 7: 2mg per day orally.
Week 8: 1mg per day orally.
Grade 1
Week 1: 300 micrograms per kg per day intravenously.
Week 2: 200 micrograms per kg per day intravenously.
Week 3: 100 micrograms per kg per day orally.
Week 4: 3mg per day orally.
Week 5: 2mg per day orally.
Week 6: 1mg per day orally.
Palliative treatment of neoplastic diseases
3mg to 20mg per day, depending on the cause and severity. Very high doses up to 96mg may also be used for palliative care.
Prevention and treatment of post-operative vomiting, within antiemetic treatment: Single dose of 8mg before surgery.
Symptomatic treatment of multiple myeloma, acute lymphocytic leukaemia, acute lymphoblastic leukaemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products
Usually 40mg to 20mg daily.
Consult the product literature for the co-administered medicinal product for suggested dexamethasone dosage regimens. Local or international protocols should be followed where appropriate.
Coronavirus disease 2019: 6mg once daily for up to 10 days.
Children
10 micrograms to 100 micrograms per kg bodyweight daily.
Children on prolonged therapy should be carefully monitored. The optimal dosage will depend on body weight and clinical condition being treated.
Croup
Single dose of 150 micrograms/kg. A second dose may be administered after 12 hours if required.
Some manufacturers recommend a single dose of 150 micrograms/kg to 600 micrograms/kg, and repeat after 12 hours if required.
The following alternative dosing schedule may also be suitable:
150 microgram/kg initially, to be given before arriving to hospital. Then a dose of 150 micrograms/kg and another 150 microgram/kg after 12 hours if required.
Acute asthma
0.6mg per kg body weight for one or two days.
Dosage should be limited to a single dose on alternate days to lessen risk of growth retardation and minimise suppression of hypothalamo-pituitary-adrenal axis.
Coronavirus disease 2019
Children aged 12 to 18 years old weighing at least 40kg
6mg once daily for up to 10 days.
The following alternative dosing schedule may be suitable:
For inflammatory and allergic disorders
10 micrograms/kg to 100 micrograms/kg bodyweight daily in 1 to 2 divided doses, adjusted according to response. Up to 300 micrograms/kg bodyweight daily may be required in emergency situations.
For physiological replacement
250 micrograms to 500 micrograms per square metre every 12 hours, adjusted according to response.
Coronavirus disease 2019
Children aged 1 month to 18 years (unlicensed)
150 micrograms/kg once daily for 10 days. Maximum 6mg once daily.
Additional Dosage Information
Using the lowest effective dose for a minimum period and where appropriate administering the daily requirement as a single morning dose minimises undesirable effects.
The following equivalents facilitate changing to dexamethasone from other glucocorticoids:
Milligram for milligram:
dexamethasone is approximately equivalent to betamethasone.
4 to 6 times more potent than methylprednisolone and triamcinolone.
6 to 8 times more potent than prednisone and prednisolone.
25 to 30 times more potent than hydrocortisone, and
about 35 times more potent than cortisone.
Withdrawing therapy
Patients receiving doses greater than approximately 1mg of dexamethasone daily (approximately normal physiological levels) for more than 3 weeks should be withdrawn gradually. Reduction method will depend on the likelihood of disease relapse during dose reduction. Clinical assessment of disease activity may be required during withdrawal. If relapse is unlikely but there is uncertainty about HPA suppression, the dose may be reduced rapidly to 1mg dexamethasone and then reduced more slowly to allow HPA-axis recovery.
If the relapse is unlikely and up to 6mg dexamethasone has been given for less than 3 weeks then abrupt withdrawal is unlikely to result in clinically relevant HPA-axis suppression in the majority of patients.
Even after less than 3 weeks treatment, gradual withdrawal should be considered in the following patient groups:
Patients who have had repeated systemic steroid courses especially if courses were for longer than 3 weeks.
When a short course has been prescribed within one year of stopping a course that had lasted for months or years.
Patients at risk of adrenocortical insufficiency other than exogenous corticosteroid therapy.
Patients receiving doses greater than 6mg daily of dexamethasone.
Patients repeatedly taking doses in the evenings.
Contraindications
Uncontrolled systemic infection
Galactosaemia
Precautions and Warnings
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Infection
Breastfeeding
Congestive cardiac failure
Corneal damage
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastrointestinal anastomosis
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
Hepatic impairment
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Lactose intolerance
Migraine
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
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 activate latent amoebiasis
May mask symptoms or signs of infections
Patients with diabetes may experience fluctuations in blood glucose
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Passive immunisation of chicken pox / herpes zoster may be required
Contains lactose
Some formulations contain sunset yellow (E110); may cause allergic reaction
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood pressure regularly
Monitor patients at risk of tumour lysis syndrome
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 dexamethasone 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 dexamethasone 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 dexamethasone with caution during pregnancy.
The manufacturer advises that dexamethasone is used only if the benefits to the mother outweigh the potential risk to the foetus. 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 treatment during pregnancy using dexamethasone have caused foetal abnormalities such as cleft palate, intrauterine growth retardation and effects on brain growth and development.
Dexamethasone readily crosses the placenta, foetal serum concentrations are similar to maternal concentrations. Administration for prolonged periods or repeatedly during pregnancy may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids. However this will usually resolve following birth and is rarely clinically significant. Monitor infants born to mothers who have received substantial doses of corticosteroids during pregnancy for signs of hypoadrenalism.
Patients with pre-eclampsia or fluid retention should be closely monitored. High doses in weeks 8 to 11, may warrant an ultrasonographic evaluation for cleft palate or cleft lip.
Lactation
Use dexamethasone with caution during breastfeeding.
The manufacturer advises that a decision on whether to discontinue breastfeeding or treatment with dexamethasone should be made taking into account the benefit of breastfeeding to the child and dexamethasone to the woman. Corticosteroids are excreted into breast milk and may interfere with endogenous corticosteroid production and cause other undesirable effects. Infants of mothers receiving prolonged high dose corticosteroid therapy may experience a degree of adrenal suppression.
Schaefer (2015) states that repeated high doses may warrant withholding from breastfeeding for 3 to 4 hours from last dexamethasone dose.
Side Effects
Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Allergic dermatitis
Amenorrhoea
Amnesia
Anaphylaxis
Angioneurotic oedema
Anxiety
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Bowel perforation
Bradycardia
Candidiasis
Central serous chorioretinopathy
Cognitive impairment
Confusion
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delusions
Depression
Dyspepsia
Ecchymosis
Emotional lability
Erythema
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Glaucoma
Hair thinning
Hallucinations
Headache
Hiccough
Hirsutism
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypokalaemic alkalosis
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Increased appetite
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility to infection
Increased sweating
Insomnia
Interference with spermatogenesis
Irregular menstruation
Irritability
Leucocytosis
Malaise
Mania
Muscle weakness
Myocardial rupture following recent myocardial infarction
Nausea
Negative calcium balance
Negative protein balance
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Premature closure of epiphyses
Proximal myopathy
Pseudotumour cerebri
Psychiatric disorders
Psychological dependence
Psychotic reactions
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced muscle mass
Scleral thinning
Secondary adrenocortical and pituitary unresponsiveness
Sleep disturbances
Sodium/water retention
Striae
Suicidal tendencies
Suppression of growth in children and adolescents
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thinning of skin
Thromboembolism
Ulcerative oesophagitis
Urticaria
Vertebral and long bone fractures
Vertigo
Visual disturbances
Vomiting
Weight gain
Withdrawal syndrome - see product information
Wound healing retarded
Effects on Laboratory Tests
False negative results may occur with the nitroblue tetrazolium test for bacterial infection.
May suppress skin reaction to allergy testing.
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: October 2020
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: Dexamethasone 2mg tablets. Aspen Pharma Trading Ltd. Revised January 2018.
Summary of Product Characteristics: Dexamethasone 4mg tablets. Consilient Health Ltd. Revised October 2019.
Summary of Product Characteristics: Dexamethasone 4mg tablets. Krka dd Novo mesto. Revised December 2020.
Summary of Product Characteristics: Dexamethasone 4mg tablets. Advanz Pharma. Revised May 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 October 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
Dexamethasone. Last revised: 31 October 2018
Last accessed: 08 October 2020
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