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Hydrocortisone granules in capsules for opening


Hydrocortisone granules in capsules for opening.

Drugs List

  • ALKINDI 0.5mg granules in capsules for opening
  • ALKINDI 1mg granules in capsules for opening
  • ALKINDI 2mg granules in capsules for opening
  • ALKINDI 5mg granules in capsules for opening
  • hydrocortisone 0.5mg granules in capsules for opening
  • hydrocortisone 1mg granules in capsules for opening
  • hydrocortisone 2mg granules in capsules for opening
  • hydrocortisone 5mg granules in capsules for opening
  • Therapeutic Indications


    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).


    Replacement therapy to be given by oral administration of granules.

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


    No dosage recommendations for this age group.


    Primary and Secondary Adrenal insufficiency
    8 to 10mg/metre squared/day, divided into three or four doses, titrate to response.

    Congenital adrenal hyperplasia
    10 to 15mg/metre squared/day, divided into three or four doses, titrate to response.


    Adrenal insufficiency alone
    8 to 10mg/metre squared/day, divided into three or four doses, titrate to response.

    Congenital adrenal hyperplasia
    10 to 15mg/metre squared/day divided into three or four doses, titrate to response.



    Precautions and Warnings

    Premature infants
    Diabetes mellitus
    Epileptic disorder
    Gastrointestinal anastomosis
    History of steroid myopathy
    Metastatic carcinoma
    Peptic ulcer
    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


    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 ( ) or if this is unavailable at the backup site ( ).


    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


    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
    Acute pancreatitis
    Aggravation of schizophrenia
    Allergic dermatitis
    Anaphylactoid reaction
    Angioneurotic oedema
    Aseptic necrosis
    Avascular osteonecrosis
    Behavioural disturbances
    Blurred vision
    Changes in mood
    Congestive cardiac failure
    Corneal thinning
    Cushingoid changes
    Exacerbation of diabetes
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Fluid retention
    Gastro-intestinal perforation
    Growth retardation (children)
    Hypersensitivity reactions
    Hypokalaemic alkalosis
    Increased appetite
    Increased calcium excretion
    Increased intra-ocular pressure
    Increased susceptibility and severity of infections
    Increased sweating
    Inflammatory bowel disease
    Irregular menstruation
    Muscle weakness
    Myocardial rupture following recent myocardial infarction
    Oesophageal candidiasis
    Opportunistic infections
    Peptic ulceration with perforation and haemorrhage
    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
    Suppression of growth in children and adolescents
    Suppression of reactions to skin tests
    Suppression of the hypothalamic-pituitary-adrenal axis
    Tendon rupture
    Thinning of skin
    Ulcerative oesophagitis
    Vertebral and long bone fractures
    Visual disturbances
    Weight gain
    Wound healing retarded


    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 ( ) or if this is unavailable at the backup site ( ).

    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:
    Last accessed: 18 March 2021

    NICE Evidence Services Available at: Last accessed: 21 September 2018

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Hydrocortisone Last revised: 03 January 2018
    Last accessed: 21 September 2018

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