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Corticosteroid (oxazoline derivative of prednisolone) Pregnancy: UK SPC (Calcort 6mg Tablets) §4.6, verbatim. Pregnancy: 'The ability of corticosteroids to cross the placenta varies between individual drugs, however, deflazacort does cross the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state.' Breast-feeding: 'Corticosteroids are excreted in breast milk, although no data are available for deflazacort. Doses of up to 50 mg daily of deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.' Fertility: 'No data is available on Deflazacort and its effects on fertility.'

Deflazacort

Brand names: Calcort, Emflaza (US)

Deflazacort is an oral glucocorticoid corticosteroid used for its anti-inflammatory and immunosuppressant effects, including in Duchenne muscular dystrophy.

Adult dose

Dose: General corticosteroid therapy, individually titrated: for acute disorders up to 120 mg/day may need to be given initially; maintenance doses in most conditions are within the range 3–18 mg/day. Rheumatoid arthritis: maintenance usually 3–18 mg/day. Acute bronchial asthma attack: high doses of 48–72 mg/day may be needed depending on severity, reduced gradually once the attack has been controlled. Potency conversion: 6 mg deflazacort has approximately the same anti-inflammatory potency as 5 mg prednisolone or prednisone.
Route: Oral (Calcort 6 mg tablets)
Frequency: Once daily. §4.4: undesirable effects may be minimised 'by administering the daily requirement as a single morning dose or whenever possible as a single morning dose on alternate days'.
Max: 120 mg daily — the initial dose for acute disorders and the highest adult figure the label states. It is a ceiling, not a target: the label's overriding instruction is 'The lowest dose that will produce an acceptable response should be used.'
The source recovered in this bundle is the UK SPC for 'Calcort 6mg Tablets' (eMC product 13999) — the page's own UK brand, oral, with general glucocorticoid posology. || VERBATIM §4.2, adults, in full: 'Adults For acute disorders, up to 120 mg/day deflazacort may need to be given initially. Maintenance doses in most conditions are within the range 3 – 18 mg/day. The following regimens are for guidance only. Rheumatoid arthritis: The maintenance dose is usually within the range 3 – 18 mg/day. The smallest effective dose should be used and increased if necessary. Bronchial asthma: In the treatment of an acute attack, high doses of 48 – 72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms. Other conditions: The dose of deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg deflazacort.' || GOVERNING PRINCIPLE, verbatim: 'Doses vary widely in different diseases and different patients. In more serious and life-threatening conditions, high doses of deflazacort may need to be given. When deflazacort is used long term in relatively benign chronic diseases, the maintenance dose should be kept as low as possible. Dosage may need to be increased during periods of stress or in exacerbation of illness. The dosage should be individually titrated according to diagnosis, severity of disease and patient response and tolerance.' || WITHDRAWAL — do not stop abruptly, verbatim §4.2: 'In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. … If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiological doses. Once a daily dose equivalent to 9 mg deflazacort is reached, dose reduction should be slower to allow the HPA-axis to recover. Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 48 mg daily of deflazacort, or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients.' §4.2 then lists the groups needing gradual withdrawal even after courses of 3 weeks or less: repeated courses of systemic corticosteroids particularly if taken for more than 3 weeks; a short course prescribed within one year of stopping long-term therapy; other reasons for adrenocortical insufficiency; doses greater than 48 mg daily of deflazacort or equivalent; and patients repeatedly taking doses in the evening. || ELDERLY, verbatim: 'In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.' || US LABELLING IS ALSO IN THIS BUNDLE BUT WAS NOT USED FOR THIS FIELD: the openFDA provider carries a US label for 'Deflazacort Oral Suspension' (Zydus, 2026-07-23) that is licensed for Duchenne muscular dystrophy only, gives a single weight-based dose, and gives no fixed-milligram dosing for any inflammatory, allergic, rheumatic or immunosuppressive indication. The UK SPC above is the source for everything in this field. The US DMD figure is recorded, clearly attributed, in paedDose.notes.

Paediatric dose

Dose: 0.25 mg/kg/day
Route: Oral (Calcort 6 mg tablets)
Frequency: Once daily as a single morning dose; §4.2 adds 'Alternate day administration may be appropriate'
Max: 1.5 mg/kg/day
⚠️ UNIT: mg/kg/DAY — a total daily dose given once daily, not a per-dose figure. VERBATIM §4.2 paediatric population, in full: 'There has been limited exposure of children to deflazacort in clinical trials. In children, the indications for glucocorticoids are the same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate (see section 4.4). Doses of deflazacort usually lie in the range 0.25 – 1.5 mg/kg/day. The following ranges provide general guidance: Juvenile chronic arthritis: The usual maintenance dose is between 0.25 – 1.0 mg/kg/day. Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need. Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25 – 1.0 mg/kg deflazacort on alternate days.' || WHY dosePerKg IS 0.25: the SPC gives a RANGE (0.25 – 1.5 mg/kg/day) and no single figure, so the calculator is seeded with the label's own lower bound and the label's own upper bound is carried in maxDose. Nothing has been averaged, scaled or derived. Choose within 0.25–1.5 mg/kg/day by indication using the label's own bands above — juvenile chronic arthritis 0.25–1.0 mg/kg/day; nephrotic syndrome usually 1.5 mg/kg/day initially, then down-titrated; bronchial asthma 0.25–1.0 mg/kg on ALTERNATE DAYS (note the alternate-day schedule for asthma, which the calculator's daily figure does not express). || concentration is NULL because the UK source product is a 6 mg TABLET, not a liquid — this bundle contains no UK suspension strength, so no volume can be calculated. || THE 0.9 mg/kg/day FIGURE IS US LABELLING FOR ONE INDICATION ONLY and is NOT the UK general paediatric dose: the openFDA provider's US label for 'Deflazacort Oral Suspension' states 'The recommended oral dosage of deflazacort oral suspension is approximately 0.9 mg/kg/day once daily', licensed for Duchenne muscular dystrophy, in patients 2 years of age and older, at a suspension strength of 22.75 mg/mL, with a US instruction to give one third of the dose with moderate or strong CYP3A4 inhibitors and to avoid moderate or strong CYP3A4 inducers. It is recorded here for reference and clearly attributed; it must not be applied to asthma, croup, nephrotic syndrome, juvenile chronic arthritis or any other indication, and it is not the figure the calculator uses. || SAFETY: the SPC itself warns 'There has been limited exposure of children to deflazacort in clinical trials.' Verify any paediatric dose against a children's formulary and current prescribing references before prescribing.

Dose adjustments

Renal

UK SPC §4.2, verbatim: 'In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.'

Hepatic

UK SPC §4.2, verbatim: 'In patients with hepatic impairment, blood levels of deflazacort may be increased. Therefore, the dose of deflazacort should be carefully monitored and adjusted to the minimum effective dose.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

⚠️ UNIT: mg/kg/DAY — a total daily dose given once daily, not a per-dose figure. VERBATIM §4.2 paediatric population, in full: 'There has been limited exposure of children to deflazacort in clinical trials. In children, the indications for glucocorticoids are the same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate (see section 4.4). Doses of deflazacort usually lie in the range 0.25 – 1.5 mg/kg/day. The following ranges provide general guidance: Juvenile chronic arthritis: The usual maintenance dose is between 0.25 – 1.0 mg/kg/day. Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need. Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25 – 1.0 mg/kg deflazacort on alternate days.' || WHY dosePerKg IS 0.25: the SPC gives a RANGE (0.25 – 1.5 mg/kg/day) and no single figure, so the calculator is seeded with the label's own lower bound and the label's own upper bound is carried in maxDose. Nothing has been averaged, scaled or derived. Choose within 0.25–1.5 mg/kg/day by indication using the label's own bands above — juvenile chronic arthritis 0.25–1.0 mg/kg/day; nephrotic syndrome usually 1.5 mg/kg/day initially, then down-titrated; bronchial asthma 0.25–1.0 mg/kg on ALTERNATE DAYS (note the alternate-day schedule for asthma, which the calculator's daily figure does not express). || concentration is NULL because the UK source product is a 6 mg TABLET, not a liquid — this bundle contains no UK suspension strength, so no volume can be calculated. || THE 0.9 mg/kg/day FIGURE IS US LABELLING FOR ONE INDICATION ONLY and is NOT the UK general paediatric dose: the openFDA provider's US label for 'Deflazacort Oral Suspension' states 'The recommended oral dosage of deflazacort oral suspension is approximately 0.9 mg/kg/day once daily', licensed for Duchenne muscular dystrophy, in patients 2 years of age and older, at a suspension strength of 22.75 mg/mL, with a US instruction to give one third of the dose with moderate or strong CYP3A4 inhibitors and to avoid moderate or strong CYP3A4 inducers. It is recorded here for reference and clearly attributed; it must not be applied to asthma, croup, nephrotic syndrome, juvenile chronic arthritis or any other indication, and it is not the figure the calculator uses. || SAFETY: the SPC itself warns 'There has been limited exposure of children to deflazacort in clinical trials.' Verify any paediatric dose against a children's formulary and current prescribing references before prescribing.

Verify in a children's formulary

Contraindications

  • UK SPC §4.3: 'Hypersensitivity to the active substance, deflazacort or any of the excipients listed in section 6.1.'
  • UK SPC §4.3: 'Systemic infection unless specific anti-infective therapy is employed.'
  • UK SPC §4.3: 'Patients receiving live virus immunisation (see section 4.4 and 4.5).'
  • Not a labelled contraindication but a §4.4 warning that behaves like one in practice: 'Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chickenpox or herpes zoster and, if exposed, they should seek urgent medical attention.'

Side effects

  • §4.8 Endocrine — Uncommon: suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea, Cushingoid facies. Not known: growth suppression in infancy, childhood and adolescence; steroid withdrawal syndrome.
  • §4.8 Metabolism and nutrition — Common: weight gain. Uncommon: impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy; sodium and water retention with hypertension; potassium loss and hypokalaemic alkalosis when co-administered with beta-2-agonist and xanthines. Not known: negative protein and calcium balance, increased appetite; tumour lysis syndrome reported with Calcort in patients with haematological malignancies.
  • §4.8 Infections — Uncommon: increased susceptibility and severity of infections with suppression of clinical symptoms and signs; opportunistic infections; recurrence of dormant tuberculosis. Not known: candidiasis.
  • §4.8 Musculoskeletal — Uncommon: osteoporosis, vertebral and long bone fractures. Rare: muscle wasting. Not known: avascular osteonecrosis; tendonitis and tendon rupture when co-administered with quinolones; myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants); negative nitrogen balance.
  • §4.8 Cardiac — Not known: heart failure; hypertrophic cardiomyopathy in preterm infants.
  • §4.8 Nervous system — Uncommon: headache, vertigo. Not known: restlessness; increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal; aggravation of epilepsy.
  • §4.8 Psychiatric — Uncommon: depressed and labile mood, behavioural disturbances. Not known: irritable, euphoric, suicidal thoughts, psychotic reactions (including mania, delusions, hallucinations, aggravation of schizophrenia), anxiety, sleep disturbances, cognitive dysfunction including confusion and amnesia. The label adds: 'Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5 – 6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.'
  • §4.8 Eye — Not known: vision blurred, increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts. ⚠️ The §4.8 eye row is where the source-fetch limit truncates this section, so the adverse-effect list above is NOT complete.
  • §4.8 Reproductive — Not known: menstrual irregularity.

Monitoring

  • §4.4: 'Frequent patient review is required to appropriately titrate the dose against disease activity.' Give the lowest possible dose for the minimum period, as a single morning dose or single morning dose on alternate days where possible.
  • Adrenal suppression, §4.4: 'Glucocorticoid induced suppression of hypothalamic-pituitary-adrenal function is dependent on dose and duration of treatment. … Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. During prolonged therapy, any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage.'
  • Steroid treatment card, §4.4: 'Patients should carry "Steroid treatment" cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.'
  • Watch for steroid withdrawal syndrome on stopping, §4.4: 'typical symptoms include fever, anorexia, nausea, lethargy, malaise, myalgia, arthralgias, rhinitis, conjunctivitis, desquamation of the skin and painful itchy skin nodules, weakness, hypotension and weight loss. This may occur in patients even without evidence of adrenal insufficiency.'
  • Infection surveillance, §4.4: 'Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.'
  • Chickenpox / herpes zoster exposure in a non-immune patient — §4.4 directs urgent medical attention and passive immunisation with varicella zoster immunoglobulin for exposed non-immune patients. ⚠️ §4.4 is truncated at the source-fetch limit part-way through this sentence, so the full VZIG instruction was not retrieved.
  • Growth in children — §4.8 lists growth suppression in infancy, childhood and adolescence as a labelled effect; monitor growth on prolonged treatment.

Clinical monograph

How it works

It binds glucocorticoid receptors to modulate gene expression, suppressing inflammation and immune responses.

Prescribing in practice

  • Prolonged use causes adrenal suppression, so it must not be stopped abruptly and the dose should be tapered gradually; patients require sick-day guidance.
  • Long-term corticosteroid use carries risks including growth suppression in children, osteoporosis, weight gain, hyperglycaemia and increased infection susceptibility.
  • Live vaccines should generally be avoided during immunosuppressive doses, and exposure to chickenpox or measles in non-immune patients needs prompt assessment.

Monitoring

Monitor growth in children, weight, blood pressure, blood glucose and bone health during long-term treatment.

Counselling the patient

  • Never stop this medicine suddenly; carry a steroid alert card and follow sick-day advice if unwell.
  • Avoid contact with chickenpox or measles if you have not had them, and report any exposure.
  • Report increased thirst, frequent infections or mood changes to your team.

Evidence & guidelines

Corticosteroids such as deflazacort are recommended to preserve muscle function in Duchenne muscular dystrophy.

Reference: SmPC Calcort; DMD Care Considerations Lancet Neurol 2018; FDA Approval Emflaza (deflazacort) for DMD 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.