Hydrocortisone sodium phosphate soluble tablets
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Soluble tablets containing hydrocortisone sodium phosphate.
Adrenal insufficiency - cortical
Congenital adrenal hyperplasia
Hypersensitivity: emergency treatment
Replacement therapy in congenital adrenal hyperplasia in children.
Emergency treatment of severe bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema and anaphylaxis in adults and children.
60mg to 80mg every 4 to 6 hours for 24 hours, then gradually reduce the dose over several days.
10mg to 30mg daily, to be given in divided doses.
Give larger doses in the morning and smaller doses in the evening.
Additional Dosage Information
Gradual withdrawal of therapy will be required in patients who have received more than 30mg hydrocortisone (approximate physiological dose) 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, a rapid reduction of dosage to 30mg daily may be effected, then 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;
patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy;
patients receiving doses greater than 160mg daily;
patients repeatedly taking doses in the evening.
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
Congestive cardiac failure
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Ocular herpes simplex infection
Recent myocardial infarction
Severe affective disorders
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 mask symptoms or signs of infections
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
Contains sodium benzoate: may increase risk of jaundice in neonates
Passive immunisation of chicken pox / herpes zoster may be required
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
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
Breastfeeding: Risk of adrenal suppression in breastfed infant
Corticosteroids may cause growth retardation in children under 18 years
May cause activation of latent psychosis
May exacerbate diabetes mellitus
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
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise patient that menstrual irregularities may occur
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Consider issuing Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Hydrocortisone may exacerbate systemic fungal infections and should not be used in the presence of such infections, unless it is needed to control serious drug reactions to amphotericin.
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 hydrocortisone 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 hydrocortisone therapy, an upward dosage adjustment may be required.
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.
Pregnancy and Lactation
Use hydrocortisone with caution in pregnancy.
The manufacturer recommends that hydrocortisone is used with caution and only when the benefits outweigh the potential risks for both the mother and infant.
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. However, adverse effects have been reported.
Hydrocortisone can be used during breastfeeding.
The manufacturer recommends that if hydrocortisone is used during breastfeeding, the treatment should be carefully documented in the infants medical records.
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.
Aggravation of schizophrenia
Central serous chorioretinopathy
Changes in mood
Congestive cardiac failure
Exacerbation of diabetes
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Inflammatory bowel disease
Myocardial rupture following recent myocardial infarction
Negative calcium balance
Negative protein balance
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Precipitation of diabetes
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced carbohydrate tolerance
Reduced muscle mass
Suppression of growth in children and adolescents
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin
Vertebral and long bone fractures
Wound healing retarded
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.
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 ).
Last Full Review Date: February 2019.
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 10mg soluble tablets. Colonis Pharma Limited. Revised March 2018.
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