Drugs List

Therapeutic Indications

Uses

Congenital adrenal hyperplasia
Primary and secondary adrenal insufficiency

Replacement therapy of primary and secondary adrenal insufficiency in infants, children and adolescents (from birth to less than 18 years old).

Contraindications

Dysphagia

Precautions and Warnings

Infection
Premature infants
Breastfeeding
Diabetes mellitus
Epileptic disorder
Gastrointestinal anastomosis
History of steroid myopathy
Hypertension
Hypothyroidism
Metastatic carcinoma
Peptic ulcer
Pregnancy
Severe affective disorders
Ulcerative colitis

Anaesthetist should be made aware patient is taking this medication
Consider reintroducing steroids temporarily during illness/trauma/surgery
Temporary increase in dose may be needed during illness, trauma or surgery
Monitor growth of children during treatment
Monitor closely for 1 week if switching from tablet to granule formulation
Capsules must not be swallowed
Capsules to be opened and granules inside are to be swallowed whole
Not suitable for nasogastric administration
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor weight and blood pressure
Psychological changes may occur during initiation & withdrawal of treatment
Advise patient to report symptoms of infection immediately
Corticosteroids may cause growth retardation in children under 18 years
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
Advise patient that empty granule shells may be observed in stools
Consider issuing Steroid Treatment/Steroid Emergency Card

Premature infants where oral feeding has not been established must not use this product.

In situations where the child is vomiting or acutely unwell, oral hydrocortisone should be replaced by parenteral hydrocortisone without delay. Carers should be trained in administering this in an emergency.

All infections should be treated seriously and stress dosing of steroid initiated early. Caution in patients with adrenal insufficiency as they are at risk of life-threatening adrenal crisis during infection.

Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions, both during treatment and whilst the corticosteroid is being withdrawn. A serious paranoid state or depression with risk of suicide can be induced and patients with a history of mental disorder are at particular risk. These reactions often subside on dose reduction or withdrawal of treatment but some may require specific management. Patients should be advised to seek medical advice if psychiatric symptoms occur, especially depression or ideas of suicide.

Treatment should be limited to the minimum dosage needed to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual. Excessive weight gain with decreased height or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement. Infants should be evaluated at a minimum of every 3 to 4 months to assess growth, blood pressure, and general well-being.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution in pregnancy.

Hydrocortisone readily crosses the placenta.

Animal studies using corticosteroids in pregnancy have shown reproductive toxicity. Briggs (2015) states that despite the large amount of data from animal studies showing teratogenic and toxic effects, this does not support the effects in the great majority of human pregnancies.

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

Hydrocortisone can be used during breastfeeding.

Briggs (2015) states that trace amounts of hydrocortisone are excreted into breast milk and it is unlikely hydrocortisone poses a risk in pregnancy.

Schaefer (2015) recommends that prednisolone, prednisone and methylprednisolone are the corticoids of choice for systemic treatment during breastfeeding.

The manufacturer states that hydrocortisone can be used during breastfeeding.

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
Allergic dermatitis
Amenorrhoea
Amnesia
Anaphylactoid reaction
Anaphylaxis
Angioneurotic oedema
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Changes in mood
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delusions
Dyspepsia
Ecchymosis
Erythema
Euphoria
Exacerbation of diabetes
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fluid retention
Gastritis
Gastro-intestinal perforation
Glaucoma
Growth retardation (children)
Hallucinations
Headache
Hirsutism
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypokalaemic alkalosis
Increased appetite
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Increased sweating
Inflammatory bowel disease
Irregular menstruation
Leucocytosis
Malaise
Mania
Muscle weakness
Myocardial rupture following recent myocardial infarction
Nausea
Oesophageal candidiasis
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Precipitation of diabetes
Proximal myopathy
Psychiatric disorders
Psychosis
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Reduced muscle mass
Scleral thinning
Sleep disturbances
Sodium retention
Striae
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
Weight gain
Wound healing retarded

Presentation

Hydrocortisone granules in capsules for opening.

Drugs List

Therapeutic Indications

Uses

Congenital adrenal hyperplasia
Primary and secondary adrenal insufficiency

Replacement therapy of primary and secondary adrenal insufficiency in infants, children and adolescents (from birth to less than 18 years old).

Dosage

Replacement therapy to be given by oral administration of granules.

Dosage must be individualised according to the response of the individual patients.

Adults

Children

Neonates

Contraindications

Dysphagia

Precautions and Warnings

Infection
Premature infants
Breastfeeding
Diabetes mellitus
Epileptic disorder
Gastrointestinal anastomosis
History of steroid myopathy
Hypertension
Hypothyroidism
Metastatic carcinoma
Peptic ulcer
Pregnancy
Severe affective disorders
Ulcerative colitis

Anaesthetist should be made aware patient is taking this medication
Consider reintroducing steroids temporarily during illness/trauma/surgery
Temporary increase in dose may be needed during illness, trauma or surgery
Monitor growth of children during treatment
Monitor closely for 1 week if switching from tablet to granule formulation
Capsules must not be swallowed
Capsules to be opened and granules inside are to be swallowed whole
Not suitable for nasogastric administration
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor weight and blood pressure
Psychological changes may occur during initiation & withdrawal of treatment
Advise patient to report symptoms of infection immediately
Corticosteroids may cause growth retardation in children under 18 years
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
Advise patient that empty granule shells may be observed in stools
Consider issuing Steroid Treatment/Steroid Emergency Card

Premature infants where oral feeding has not been established must not use this product.

In situations where the child is vomiting or acutely unwell, oral hydrocortisone should be replaced by parenteral hydrocortisone without delay. Carers should be trained in administering this in an emergency.

All infections should be treated seriously and stress dosing of steroid initiated early. Caution in patients with adrenal insufficiency as they are at risk of life-threatening adrenal crisis during infection.

Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions, both during treatment and whilst the corticosteroid is being withdrawn. A serious paranoid state or depression with risk of suicide can be induced and patients with a history of mental disorder are at particular risk. These reactions often subside on dose reduction or withdrawal of treatment but some may require specific management. Patients should be advised to seek medical advice if psychiatric symptoms occur, especially depression or ideas of suicide.

Treatment should be limited to the minimum dosage needed to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual. Excessive weight gain with decreased height or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement. Infants should be evaluated at a minimum of every 3 to 4 months to assess growth, blood pressure, and general well-being.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution in pregnancy.

Hydrocortisone readily crosses the placenta.

Animal studies using corticosteroids in pregnancy have shown reproductive toxicity. Briggs (2015) states that despite the large amount of data from animal studies showing teratogenic and toxic effects, this does not support the effects in the great majority of human pregnancies.

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

Hydrocortisone can be used during breastfeeding.

Briggs (2015) states that trace amounts of hydrocortisone are excreted into breast milk and it is unlikely hydrocortisone poses a risk in pregnancy.

Schaefer (2015) recommends that prednisolone, prednisone and methylprednisolone are the corticoids of choice for systemic treatment during breastfeeding.

The manufacturer states that hydrocortisone can be used during breastfeeding.

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

Ensure patients receives steroid card if necessary.

Advise patient to read patient information leaflet.

Capsules must not be swallowed.

Capsules to be opened, granules inside to be swallowed whole.

Granules must not be added to liquid.

Advise patients to drink a liquid immediately after administration.

Granules may be taken with soft food and swallowed whole within 5 minutes.

Advise patients that empty granule shells may be observed in stools.

Advise patient to report symptoms of infection immediately.

Side Effects

Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Allergic dermatitis
Amenorrhoea
Amnesia
Anaphylactoid reaction
Anaphylaxis
Angioneurotic oedema
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Changes in mood
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delusions
Dyspepsia
Ecchymosis
Erythema
Euphoria
Exacerbation of diabetes
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fluid retention
Gastritis
Gastro-intestinal perforation
Glaucoma
Growth retardation (children)
Hallucinations
Headache
Hirsutism
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypokalaemic alkalosis
Increased appetite
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Increased sweating
Inflammatory bowel disease
Irregular menstruation
Leucocytosis
Malaise
Mania
Muscle weakness
Myocardial rupture following recent myocardial infarction
Nausea
Oesophageal candidiasis
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Precipitation of diabetes
Proximal myopathy
Psychiatric disorders
Psychosis
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Reduced muscle mass
Scleral thinning
Sleep disturbances
Sodium retention
Striae
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
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: September 2018

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: Alkindi 0.5mg, 1mg, 2mg 5mg granules in capsules for opening. Diurnal Limited. Last revised June 2018.

Summary of Product Characteristics: Hydrocortisone 10mg Tablets. Concordia International. Last revised July 2017.
Summary of Product Characteristics: Hydrocortisone 20mg Tablets. Concordia International. Last revised July 2017.

MHRA Drug Safety Update February 2021
Available at: https://www.mhra.gov.uk
Last accessed: 18 March 2021

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 September 2018

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
Hydrocortisone Last revised: 03 January 2018
Last accessed: 21 September 2018