Drugs List

Therapeutic Indications

Uses

Adrenocortical insufficiency

Contraindications

Children under 18 years
Gastrointestinal hypermotility

Precautions and Warnings

Elderly
Breastfeeding
Diabetes mellitus
Hyperthyroidism
Hypothyroidism
Osteoporosis
Pregnancy
Severe hepatic impairment
Severe renal impairment

Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
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
Monitor dosage closely in presence of renal or hepatic impairment
Monitor regularly the height of children receiving prolonged treatment
Monitor thyroid function regularly
Possible mineralocorticoid secretion suppression & need for supplementation
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
Do not withdraw this drug suddenly
Advise patient not to take St John's wort concurrently
Absorption may be reduced by diarrhoea or vomiting
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.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

Hydrocortisone readily crosses the placenta. Schaefer (2007) suggest that 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.

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 hydrocortisone with caution in breastfeeding.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2007) and Briggs (2011) 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.

Infant of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.

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 pain
Acne
Aggravation of gastric ulcer
Cushing's syndrome
Decrease in bone mineral density
Decreased glucose tolerance
Dental decay
Diarrhoea
Dry eyes
Dyspepsia
Ecchymosis
Euphoria
Exacerbation of infection
Fatigue
Gastro-enteritis
Hirsutism
Hypertension
Hypokalaemia
Increase in HDL cholesterol
Increased intra-ocular pressure
Increased risk of fractures
Insomnia
Joint swelling
Nausea
Oedema
Oesophagitis
Osteoporosis
Precipitation of diabetes
Pruritic rash
Psychosis
Sedation
Sodium/water retention
Striae
Subcapsular cataract
Upper abdominal pain
Upper respiratory tract infection
Vertigo
Viral infection
Weight gain
Wound healing retarded

Presentation

Modified release tablets containing hydrocortisone.

Drugs List

Therapeutic Indications

Uses

Adrenocortical insufficiency

Dosage

Adults

Contraindications

Children under 18 years
Gastrointestinal hypermotility

Precautions and Warnings

Elderly
Breastfeeding
Diabetes mellitus
Hyperthyroidism
Hypothyroidism
Osteoporosis
Pregnancy
Severe hepatic impairment
Severe renal impairment

Consider increased dose during intercurrent illness/trauma/surgery
Consider reintroducing steroids temporarily during illness/trauma/surgery
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
Monitor dosage closely in presence of renal or hepatic impairment
Monitor regularly the height of children receiving prolonged treatment
Monitor thyroid function regularly
Possible mineralocorticoid secretion suppression & need for supplementation
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
Do not withdraw this drug suddenly
Advise patient not to take St John's wort concurrently
Absorption may be reduced by diarrhoea or vomiting
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.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with caution during pregnancy.

Hydrocortisone readily crosses the placenta. Schaefer (2007) suggest that 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.

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 hydrocortisone with caution in breastfeeding.

Corticosteroids are excreted in small amounts in breast milk, and both Schaefer (2007) and Briggs (2011) 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.

Infant of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.

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

Patients should carry a 'steroid treatment' card which gives clear guidance on the precautions to be taken to minimise risk and which provides details of prescriber, drug, dosage and the duration of treatment.

Advise patients that if they are affects by side effects such as vertigo, visual field loss or muscle weakness, they should not drive or operate machinery.

Advise patients to see medical advice in the event of worrying psychological changes, particularly depression or suicidal thoughts.

Side Effects

Abdominal pain
Acne
Aggravation of gastric ulcer
Cushing's syndrome
Decrease in bone mineral density
Decreased glucose tolerance
Dental decay
Diarrhoea
Dry eyes
Dyspepsia
Ecchymosis
Euphoria
Exacerbation of infection
Fatigue
Gastro-enteritis
Hirsutism
Hypertension
Hypokalaemia
Increase in HDL cholesterol
Increased intra-ocular pressure
Increased risk of fractures
Insomnia
Joint swelling
Nausea
Oedema
Oesophagitis
Osteoporosis
Precipitation of diabetes
Pruritic rash
Psychosis
Sedation
Sodium/water retention
Striae
Subcapsular cataract
Upper abdominal pain
Upper respiratory tract infection
Vertigo
Viral infection
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 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of product characteristics: Plenadren 5mg modified-release tablets. Shire Pharmaceuticals Limited. Revised May 2018.

Summary of product characteristics: Plenadren 20mg modified-release tablets. Shire Pharmaceuticals Limited. Revised May 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 January 2021