Hydrocortisone oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of hydrocortisone.
Drugs List
Therapeutic Indications
Uses
Adrenal insufficiency - cortical
Congenital adrenal hyperplasia
Hypersensitivity: emergency treatment
Dosage
Adults
Replacement therapy
20mg to 30mg daily in two divided doses. Give larger doses in the morning and smaller doses in the evening.
Acute Emergencies
60mg to 80mg every 4 to 6 hours for 24 hours. Gradually reduce the dose over several days.
Children
Replacement therapy
10mg to 30mg daily in two divided doses. Give larger doses in the morning and smaller doses in the evening.
The following alternative dosing schedule may be suitable:
Replacement therapy
0.4mg/kg to 0.8mg/kg daily in two or three divided doses. Titrate to response.
Adrenal hypoplasia, Addison's disease, chronic maintenance or replacement therapy
8 to 10mg/square metre daily, given in three divided doses. Higher doses may be required.
Give larger doses in the morning and smaller doses in the evening.
Congenital adrenal hyperplasia
9 to 15mg/square metre daily, given in three divided doses. Titrate to response.
Additional Dosage Information
Hydrocortisone Withdrawal
Gradual withdrawal of therapy will be required in patients who have received more than physiological doses of systemic corticosteroids (approximately 30mg hydrocortisone) for greater than 3 weeks. Determine how dose reduction is to be carried out based on the likelihood of disease relapse on withdrawal and likelihood of hypothalamic-pituitary-adrenal (HPA) suppression. If disease is unlikely to relapse but hypothalamic-pituitary adrenal suppression is uncertain the dose may be reduced rapidly to physiological doses. Once a daily dose equivalent to 30mg hydrocortisone is reached, dose reduction should be slowed down to allow the HPA-axis to recover.
Abrupt withdrawal of systemic hydrocortisone 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 of up to 160mg daily of hydrocortisone for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression in the majority of patients.
In the following patient groups gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
Patients who have had repeated courses of systemic corticosteroids, especially if taken for greater than 3 weeks,
When a short course has been prescribed within one year of cessation of long term therapy (months or years),
Patients receiving doses greater than 160mg hydrocortisone,
Patients repeatedly taking doses in the evening.
Contraindications
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Breastfeeding
Chronic nephritis
Congestive cardiac failure
Corneal damage
Diabetes mellitus
Diverticulitis
Epileptic disorder
Galactosaemia
Gastrointestinal anastomosis
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
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
Osteoporosis
Peptic ulcer
Pregnancy
Recent myocardial infarction
Renal impairment
Severe affective disorders
Thromboembolic disorder
Ulcerative colitis
Administration of live vaccines is not recommended
Consider reintroducing steroids temporarily during illness/trauma/surgery
Disease reactivation may occur in patients with latent TB
Exposure to measles may require prophylaxis with normal immunoglobulin
May activate latent amoebiasis
May mask symptoms or signs of infections
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
Consider prophylactic anti-tuberculosis therapy if appropriate
Passive immunisation of chicken pox / herpes zoster may be required
Premature infants: Perform cardiac evaluation and monitoring
Some formulations contain lactose
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood pressure regularly
Monitor regularly the height of children receiving prolonged treatment
Pregnancy: Monitor closely patients with pre-eclampsia or fluid retention
Prolonged or high dose may lead to adrenal suppression
Psychological changes may occur during initiation & withdrawal of treatment
Supervise patient closely during drug withdrawal
Adrenal cortical atrophy may persist for years after stopping drug
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
May affect results of some laboratory tests
Sudden withdrawal may be inadvisable -see product information/SPC
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 avoid exposure to measles
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 (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chicken pox or herpes zoster and seek urgent medical attention if exposed as chicken pox can prove fatal in immunocompromised patients. If exposed while on dexamethasone or within three months of previous use, passive immunisation with varicella/zoster immunoglobulin (VZIG) should be administered within 10 days of the exposure. If chicken pox occurs, treat urgently under specialist care. Do not stop dexamethasone therapy, an upwards dosage adjustment may be required.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required especially during long term therapy.
Pregnancy and Lactation
Pregnancy
Use hydrocortisone with caution during pregnancy.
The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus. 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 breastfed infants of mothers taking higher doses may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.
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 distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Allergic dermatitis
Amenorrhoea
Amnesia
Anaphylaxis
Angioneurotic oedema
Anxiety
Aseptic necrosis
Avascular osteonecrosis
Behavioural disturbances
Bruising
Changes in mood
Cognitive impairment
Confusion
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid changes
Delusions
Dyspepsia
Ecchymosis
Emotional lability
Erythema
Euphoria
Exacerbation of diabetes
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fluid retention
Gastro-intestinal perforation
Glaucoma
Hallucinations
Headache
Hiccough
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
Irritability
Leucocytosis
Malaise
Mania
Muscle weakness
Myocardial rupture following recent myocardial infarction
Nausea
Negative calcium balance
Negative protein balance
Oesophageal candidiasis
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Precipitation of diabetes
Proximal myopathy
Psychiatric disorders
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Reduced muscle mass
Scleral thinning
Sleep disturbances
Sodium retention
Striae
Suicidal tendencies
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
Effects on Laboratory Tests
False negative results may occur with the nitroblue tetrazolium test for bacterial infection.
Withdrawal Symptoms and Signs
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A `withdrawal syndrome' may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and 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: April 2019
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: Hydrocortisone 2.5mg/5mg/15mg tablets. Activcase Pharmaceuticals Ltd. Revised May 2021.
Summary of Product Characteristics: Hydrocortisone 10mg tablets. Teva UK Limited. Revised June 2017.
Summary of Product Characteristics: Hydrocortisone 20mg tablets. Teva UK Limited. Revised June 2017.
Summary of Product Characteristics: Hydrocortisone 5mg Dispersible tablets. Morningside Healthcare Ltd. Revised December 2021.
Summary of Product Characteristics: Hydrocortisone 10mg Dispersible tablets. Morningside Healthcare Ltd. Revised December 2021.
Summary of Product Characteristics: Hydrocortisone 20mg Dispersible tablets. Morningside Healthcare Ltd. Revised December 2021.
Summary of Product Characteristics: Hydventia 10mg tablets. Resolution Chemicals Ltd. Revised March 2019.
Summary of Product Characteristics: Hydventia 20mg tablets. Resolution Chemicals Ltd. Revised March 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 July 2022
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