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Hydrocortisone sodium phosphate soluble tablets

Presentation

Soluble tablets containing hydrocortisone sodium phosphate.

Drugs List

  • hydrocortisone 10mg soluble tablet sugar-free
  • Therapeutic Indications

    Uses

    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.

    Dosage

    Adults

    Acute emergencies
    60mg to 80mg every 4 to 6 hours for 24 hours, then gradually reduce the dose over several days.

    Children

    Replacement therapy
    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

    Hydrocortisone Withdrawal
    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.

    Contraindications

    Uncontrolled systemic infection

    Precautions and Warnings

    Children under 18 years
    Elderly
    Family history of diabetes mellitus
    Family history of glaucoma
    Acute glomerulonephritis
    Breastfeeding
    Chronic nephritis
    Congestive cardiac failure
    Diabetes mellitus
    Diverticulitis
    Epileptic disorder
    Gastrointestinal anastomosis
    Glaucoma
    Hepatic cirrhosis
    Hepatic impairment
    History of severe affective disorders
    History of steroid myopathy
    History of steroid-induced psychosis
    History of tuberculosis
    Hypertension
    Hypothyroidism
    Metastatic carcinoma
    Myasthenia gravis
    Ocular herpes simplex infection
    Osteoporosis
    Peptic ulcer
    Pregnancy
    Recent myocardial infarction
    Renal impairment
    Severe affective disorders
    Thrombophlebitis
    Ulcerative colitis

    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

    Pregnancy

    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.

    Lactation

    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.

    Side Effects

    Abdominal distension
    Acne
    Acute pancreatitis
    Aggravation of schizophrenia
    Allergic dermatitis
    Amenorrhoea
    Amnesia
    Angioneurotic oedema
    Anxiety
    Behavioural disturbances
    Blurred vision
    Central serous chorioretinopathy
    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
    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
    Weight gain
    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.

    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: February 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 10mg soluble tablets. Colonis Pharma Limited. Revised March 2018.

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