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Oral formulations of deflazacort

Drugs List

  • CALCORT 6mg tablets
  • deflazacort 6mg tablets
  • Therapeutic Indications


    Acute asthma
    Chronic asthma
    Inflammatory or allergic conditions
    Rheumatoid arthritis

    Treatment of allergic and inflammatory conditions, rheumatoid arthritis and asthma.


    6mg deflazacort has approximately equivalent anti-inflammatory potency to 5mg prednisolone.

    Dosage should be individually titrated according to diagnosis, severity of disease and patient response and tolerance. In long term management, the dose should be kept as low as possible, but may need to be increased during periods of stress or of exacerbation of the disease being treated.

    Frequent patient review is required to appropriately titrate dose against disease activity.


    Acute disorders:
    Initial dose: 120mg daily.
    Maintenance dose: 3mg to 18mg daily.

    Rheumatoid Arthritis:
    Maintenance dose: 3mg to 18mg daily.

    Bronchial Asthma:
    Acute attack: 48mg to 72mg daily, according to severity and will be gradually decreased once the attack is controlled.
    Chronic asthma: Maintenance doses will be titrated to the lowest effective dose.

    Other Conditions
    The dose depends on clinical need titrated to the lowest effective dose for maintenance. Start doses will be estimated based on the ratio of 5mg prednisone or prednisolone to 6mg deflazacort.


    Dose range for deflazacort is usually between 250micrograms to 1.5mg/kg/day.

    Juvenile Chronic Arthritis:
    Maintenance dose: 250micrograms to 1mg/kg/day.

    Nephrotic Syndrome:
    Initial dose: 1.5mg/kg/day (maximum 120mg), followed by down titration as per clinical need.

    Bronchial Asthma:
    Initial dose: 250micrograms to 1mg/kg on alternate days.

    Inflammatory and Allergic Disorders:
    Children aged 1 month to 12 years: 250micrograms to 1.5mg/kg once daily or on alternate days. In case of emergency, 2.4mg/kg (maximum 120mg) daily.

    Children aged 12 to 18 years: 3mg to 18mg once daily or on alternate days. In case of emergency, 2.4mg/kg (maximum 120mg) daily.


    Live virus immunisation
    Uncontrolled systemic infection

    Precautions and Warnings

    Family history of diabetes mellitus
    Family history of glaucoma
    Predisposition to gastrointestinal perforation
    Cardiac disorder
    Congestive cardiac failure - except in active rheumatic carditis
    Diabetes mellitus
    Epileptic disorder
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    Hepatic impairment
    History of peptic ulcer
    History of severe affective disorders
    History of steroid myopathy
    History of steroid-induced psychosis
    History of tuberculosis
    Lactose intolerance
    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
    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
    Reduce dose in patients with hepatic impairment
    Temporary increase in dose may be needed during illness, trauma or surgery
    Passive immunisation of chicken pox / herpes zoster may be required
    Contains lactose
    Frequent review needed to titrate dose to disease activity
    Monitor patients at risk of tumour lysis syndrome
    Monitor regularly the height of children receiving prolonged treatment
    Prolonged or high dose may lead to adrenal suppression
    Psychological changes may occur during initiation & withdrawal of treatment
    Advise patient to report new visual problems and symptoms
    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
    Withdraw gradually after long-term use
    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 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 and carers should be advised of potential psychological symptoms, specially depression or suicidal thoughts. These should appear within a few days or weeks of the start of treatment. The risk is higher with higher dosage/systemic exposure and most reactions recover with dose reduction or withdrawal. Specific treatment may be required.

    Some psychiatric disturbances may also appear during or immediately after withdrawal of systemic steroids.

    Following the use of deflazacort, tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies. Monitor patients at high risk of TLS, such as patients with high proliferative rate, high tumour burden and high sensitivity to cytotoxic agents. Appropriate precautions should be taken where necessary.

    Pregnancy and Lactation


    Use deflazacort with caution in pregnancy.

    The manufacturer states that deflazacort crosses the placenta.

    Animal studies have demonstrated that corticosteroids as a class can cause anomalies such as cleft palate, intra-uterine growth retardation and affects the brain growth and development. Corticosteroids may increase the risk of intra-uterine growth retardation in humans when used for a long period of time or repeatedly during pregnancy. There may be hypoadrenalism occurring to the neonate after prenatal exposure to corticosteroids. However, this is expected to resolve on its own during birth. Corticosteroids are considered essential if the potential benefit to the mother outweighs the potential risk to the foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use deflazacort with caution in breastfeeding.

    At the time of writing there is limited published information regarding the use of deflazacort during breastfeeding.

    The manufacturer states that corticosteroids are excreted in breast milk. Systemic effects are unlikely to appear in infants of doses under 50 mg per day. Taking higher doses than 50 mg per day leads to a risk of adrenal suppression for the infant. The use of deflazacort should only be administered in breastfeeding if the potential benefit to the mother outweigh the potential risk to the infant.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at


    Advise patient to seek medical advice if developing worrying psychological symptoms, especially if depression or suicidal ideation is suspected.

    Advise patient to report any new visual symptoms.

    Advise patient to avoid close contact with chickenpox or herpes zoster and to seek medical advice if exposed.

    Advise patient to avoid contact with measles and to seek urgent medical attention if exposed.

    Side Effects

    Abdominal distension
    Acute pancreatitis
    Aggravation of schizophrenia
    Avascular osteonecrosis
    Behavioural disturbances
    Benign intracranial hypertension
    Cardiac failure
    Cognitive impairment
    Corneal thinning
    Cushingoid changes
    Emotional lability
    Exacerbation of epilepsy
    Facial erythema
    Fluid retention
    Gastro-intestinal haemorrhage
    Growth suppression in infancy, childhood and adolescence
    Hypersensitivity reactions including anaphylaxis
    Hypokalaemic alkalosis
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Impaired healing
    Increased appetite
    Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
    Increased intra-ocular pressure
    Increased susceptibility and severity of infections
    Increased sweating
    Menstrual disturbances
    Myocardial rupture following recent myocardial infarction
    Negative calcium balance
    Negative nitrogen balance
    Negative protein balance
    Oesophageal ulceration
    Opportunistic infections
    Peptic ulceration with perforation and haemorrhage
    Posterior subcapsular cataracts
    Potassium loss
    Proximal myopathy with wasting and weakness
    Psychological dependence
    Psychotic reactions
    Recurrence of dormant tuberculosis
    Scleral thinning
    Skin atrophy
    Sleep disturbances
    Sodium retention
    Suicidal tendencies
    Suppression of clinical signs of infection
    Suppression of reactions to skin tests
    Suppression of the hypothalamic-pituitary-adrenal axis
    Tendon rupture
    Tumour lysis syndrome
    Vertebral and long bone fractures
    Weight gain
    Withdrawal syndrome - see product information

    Withdrawal Symptoms and Signs

    Abrupt withdrawal of systemic corticosteroids is not recommended in patients who have received more than the physiological dose (approximately 9 mg per day or equivalent) for 3 weeks or longer. Dose reduction should be based on whether the disease is likely to deteriorate when the systemic corticosteroid is withdrawn. It is important to monitor the patient with regards to disease relapse when withdrawing the systemic corticosteroid. If the disease is unlikely to relapse, but there is uncertainty about HPA suppression, doses of systemic corticosteroids may be rapidly reduced to physiological doses. Dose reduction should be slowed when the daily dose of systemic corticosteroids reaches an equivalent of 9mg deflazacort to allow the HPA-axis to recover. Doses of up to 48 mg per day or equivalent, for 3 weeks, are unlikely to affect HPA-axis suppression.

    For the following groups of patients, systemic corticosteroid therapy needs slow withdrawal to be considered even if the course of treatment lasted up to 3 weeks.

    Patients who had repeated courses of systemic corticosteroids, specially if taken over 3 weeks.
    When a short course has been prescribed within 1 year of having stopped a long-term therapy.
    Patients which reasons for adrenocortical insufficiency are other than exogenous corticosteroid therapy. Patients receiving more than 48 mg daily of deflazacort or equivalent.
    Patients taking doses in the evening repeatedly.

    Too rapid a reduction of corticosteroid therapy following prolonged treatment may lead to the following:
    Acute adrenal insufficiency
    Painful itchy nodules
    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: January 2017

    Reference Sources

    Summary of Product Characteristics: Calcort 6 mg tablets. Aventis Pharma Ltd. Revised January 2021.

    NICE - Evidence Services
    Available at:
    Last accessed: 07 June 2017

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