Drugs List

Therapeutic Indications

Uses

Congenital adrenal hyperplasia

Treatment of congenital adrenal hyperplasia (CAH) in adults and adolescents aged 12 years and over.

Contraindications

Gastrointestinal hypermotility

Precautions and Warnings

Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
Infection
Patients over 65 years
Breastfeeding
Congestive cardiac failure
Decreased gastrointestinal motility
Delayed gastric emptying
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastrointestinal anastomosis
Glaucoma
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent myocardial infarction
Severe affective disorders
Severe hepatic impairment
Severe renal impairment
Thromboembolic disorder
Ulcerative colitis

Anaesthetist should be made aware patient is taking this medication
Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
Patients with diabetes may experience fluctuations in blood glucose
Temporary increase in dose may be needed during illness, trauma or surgery
Advise ability to drive/operate machinery may be affected by side effects
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor dosage closely in presence of renal or hepatic impairment
Monitor regularly the height of children receiving prolonged treatment
Possible mineralocorticoid secretion suppression & need for supplementation
Psychological changes may occur during initiation & withdrawal of treatment
Advise patient to seek medical advice if signs of adrenal crisis occur
Corticosteroids may cause growth retardation in children under 18 years
May cause activation of latent psychosis
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
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
Ensure patient receives Steroid Treatment/Steroid Emergency Card

During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency. In severe situation, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment. Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.

Patients should be monitored for signs of infection as they are at risk of life-threatening adrenal crisis during infection.

Adolescents should be closely monitored for signs of early puberty as they may exhibit an accelerated sexual maturation, an increase in dose should be considered.

Blood tests should be used to monitor clinical response. Evening doses are assessed by a morning blood test and morning doses are assessed by an early afternoon blood test.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

The manufacturer notes that there are no indications that hydrocortisone in pregnant women is associated with adverse consequences for the fetus. If corticosteroids are considered essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Hydrocortisone readily crosses the placenta. Schaefer and Briggs suggest there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with clefts cannot excluded. 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.

Closely monitor patients with pre-eclampsia or fluid retention.

Lactation

Use hydrocortisone with caution during breastfeeding.

The manufacturer notes that hydrocortisone used for replacement therapy do not significantly affect the child.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer and Briggs report that there are no reports to date of the use of hydrocortisone during lactation. Schaefer recommends that prednisolone and methylprednisolone are the systemic corticosteroids of choice during breastfeeding.

Side Effects

Abdominal pain
Acne
Acute pancreatitis
Aggravation of gastric ulcer
Anaphylactic reaction
Anxiety
Arthralgia
Asthenia
Avascular osteonecrosis
Behavioural disturbances
Carpal tunnel syndrome
Cognitive impairment
Congestive cardiac failure
Cushing's syndrome
Decrease in bone mineral density
Decreased glucose tolerance
Depressed mood
Diarrhoea
Disturbances of appetite
Dizziness
Dream abnormalities
Dyspepsia
Ecchymosis
Euphoria
Exacerbation of infection
Fatigue
Gastro-enteritis
Glaucoma
Hair growth abnormal
Headache
Hirsutism
Hypertension
Hypokalaemia
Hypokalaemic alkalosis
Increased intra-ocular pressure
Increased risk of fractures
Increased susceptibility and severity of infections
Increased sweating
Insomnia
Leucocytosis
Malaise
Muscle weakness
Myalgia
Nausea
Oedema
Osteoporosis
Painful extremities
Papilloedema
Paraesthesia
Precipitation of diabetes
Proximal myopathy
Psychosis
Raised intracranial pressure
Recurrence of dormant tuberculosis
Sleep disorders
Sodium/water retention
Striae
Subcapsular cataract
Suppression of growth in children and adolescents
Telangiectasia
Tendon rupture
Thromboembolism
Upper abdominal pain
Vertigo
Viral infection
Visual disturbances
Weight gain
Wound healing retarded

Presentation

Modified release capsules containing hydrocortisone.

Drugs List

Therapeutic Indications

Uses

Congenital adrenal hyperplasia

Treatment of congenital adrenal hyperplasia (CAH) in adults and adolescents aged 12 years and over.

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Gastrointestinal hypermotility

Precautions and Warnings

Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
Infection
Patients over 65 years
Breastfeeding
Congestive cardiac failure
Decreased gastrointestinal motility
Delayed gastric emptying
Diabetes mellitus
Diverticulitis
Epileptic disorder
Gastrointestinal anastomosis
Glaucoma
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent myocardial infarction
Severe affective disorders
Severe hepatic impairment
Severe renal impairment
Thromboembolic disorder
Ulcerative colitis

Anaesthetist should be made aware patient is taking this medication
Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
Patients with diabetes may experience fluctuations in blood glucose
Temporary increase in dose may be needed during illness, trauma or surgery
Advise ability to drive/operate machinery may be affected by side effects
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor dosage closely in presence of renal or hepatic impairment
Monitor regularly the height of children receiving prolonged treatment
Possible mineralocorticoid secretion suppression & need for supplementation
Psychological changes may occur during initiation & withdrawal of treatment
Advise patient to seek medical advice if signs of adrenal crisis occur
Corticosteroids may cause growth retardation in children under 18 years
May cause activation of latent psychosis
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
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
Ensure patient receives Steroid Treatment/Steroid Emergency Card

During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency. In severe situation, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment. Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.

Patients should be monitored for signs of infection as they are at risk of life-threatening adrenal crisis during infection.

Adolescents should be closely monitored for signs of early puberty as they may exhibit an accelerated sexual maturation, an increase in dose should be considered.

Blood tests should be used to monitor clinical response. Evening doses are assessed by a morning blood test and morning doses are assessed by an early afternoon blood test.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

The manufacturer notes that there are no indications that hydrocortisone in pregnant women is associated with adverse consequences for the fetus. If corticosteroids are considered essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.

Hydrocortisone readily crosses the placenta. Schaefer and Briggs suggest there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with clefts cannot excluded. 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.

Closely monitor patients with pre-eclampsia or fluid retention.

Lactation

Use hydrocortisone with caution during breastfeeding.

The manufacturer notes that hydrocortisone used for replacement therapy do not significantly affect the child.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer and Briggs report that there are no reports to date of the use of hydrocortisone during lactation. Schaefer recommends that prednisolone and methylprednisolone are the systemic corticosteroids of choice during breastfeeding.

Side Effects

Abdominal pain
Acne
Acute pancreatitis
Aggravation of gastric ulcer
Anaphylactic reaction
Anxiety
Arthralgia
Asthenia
Avascular osteonecrosis
Behavioural disturbances
Carpal tunnel syndrome
Cognitive impairment
Congestive cardiac failure
Cushing's syndrome
Decrease in bone mineral density
Decreased glucose tolerance
Depressed mood
Diarrhoea
Disturbances of appetite
Dizziness
Dream abnormalities
Dyspepsia
Ecchymosis
Euphoria
Exacerbation of infection
Fatigue
Gastro-enteritis
Glaucoma
Hair growth abnormal
Headache
Hirsutism
Hypertension
Hypokalaemia
Hypokalaemic alkalosis
Increased intra-ocular pressure
Increased risk of fractures
Increased susceptibility and severity of infections
Increased sweating
Insomnia
Leucocytosis
Malaise
Muscle weakness
Myalgia
Nausea
Oedema
Osteoporosis
Painful extremities
Papilloedema
Paraesthesia
Precipitation of diabetes
Proximal myopathy
Psychosis
Raised intracranial pressure
Recurrence of dormant tuberculosis
Sleep disorders
Sodium/water retention
Striae
Subcapsular cataract
Suppression of growth in children and adolescents
Telangiectasia
Tendon rupture
Thromboembolism
Upper abdominal pain
Vertigo
Viral infection
Visual disturbances
Weight gain
Wound healing retarded

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 2022

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: Efmody 5mg modified release hard capsules. Diurnal Europe B.V. Revised August 2021.

Summary of product characteristics: Efmody 10mg modified release hard capsules. Diurnal Europe B.V. Revised August 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 14 January 2022