Drugs List

Therapeutic Indications

Uses

Acute asthma
Chronic asthma
Inflammatory or allergic conditions
Rheumatoid arthritis

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

Contraindications

Live virus immunisation
Uncontrolled systemic infection
Galactosaemia

Precautions and Warnings

Abscess
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Predisposition to gastrointestinal perforation
Breastfeeding
Cardiac disorder
Congestive cardiac failure - except in active rheumatic carditis
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastritis
Glaucoma
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
Hypertension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Ocular herpes simplex infection
Oesophagitis
Osteoporosis
Peptic ulcer
Pregnancy
Psychosis
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Tuberculosis
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Benign intracranial hypertension
Bruising
Candidiasis
Cardiac failure
Chorioretinopathy
Cognitive impairment
Confusion
Corneal thinning
Cushingoid changes
Delusions
Depression
Dyspepsia
Ecchymosis
Emotional lability
Euphoria
Exacerbation of epilepsy
Exophthalmos
Facial erythema
Fluid retention
Gastro-intestinal haemorrhage
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Headache
Hiccups
Hirsutism
Hyperglycaemia
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemia
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
Insomnia
Irritability
Leucocytosis
Malaise
Mania
Menstrual disturbances
Myocardial rupture following recent myocardial infarction
Nausea
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Oedema
Oesophageal ulceration
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy with wasting and weakness
Psychological dependence
Psychotic reactions
Recurrence of dormant tuberculosis
Restlessness
Scleral thinning
Skin atrophy
Sleep disturbances
Sodium retention
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Tumour lysis syndrome
Urticaria
Vertebral and long bone fractures
Vertigo
Weight gain
Withdrawal syndrome - see product information

Presentation

Oral formulations of deflazacort

Drugs List

Therapeutic Indications

Uses

Acute asthma
Chronic asthma
Inflammatory or allergic conditions
Rheumatoid arthritis

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

Dosage

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.

Adults

Children

Contraindications

Live virus immunisation
Uncontrolled systemic infection
Galactosaemia

Precautions and Warnings

Abscess
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Predisposition to gastrointestinal perforation
Breastfeeding
Cardiac disorder
Congestive cardiac failure - except in active rheumatic carditis
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastritis
Glaucoma
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
Hypertension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Ocular herpes simplex infection
Oesophagitis
Osteoporosis
Peptic ulcer
Pregnancy
Psychosis
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Tuberculosis
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

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
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Benign intracranial hypertension
Bruising
Candidiasis
Cardiac failure
Chorioretinopathy
Cognitive impairment
Confusion
Corneal thinning
Cushingoid changes
Delusions
Depression
Dyspepsia
Ecchymosis
Emotional lability
Euphoria
Exacerbation of epilepsy
Exophthalmos
Facial erythema
Fluid retention
Gastro-intestinal haemorrhage
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Headache
Hiccups
Hirsutism
Hyperglycaemia
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemia
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
Insomnia
Irritability
Leucocytosis
Malaise
Mania
Menstrual disturbances
Myocardial rupture following recent myocardial infarction
Nausea
Negative calcium balance
Negative nitrogen balance
Negative protein balance
Oedema
Oesophageal ulceration
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy with wasting and weakness
Psychological dependence
Psychotic reactions
Recurrence of dormant tuberculosis
Restlessness
Scleral thinning
Skin atrophy
Sleep disturbances
Sodium retention
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Tumour lysis syndrome
Urticaria
Vertebral and long bone fractures
Vertigo
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
Hypotension
Death
Fever
Myalgia
Arthralgia
Rhinitis
Conjunctivitis
Painful itchy nodules
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: January 2017

Reference Sources

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

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 07 June 2017