Hydrocortisone (as sodium phosphate) parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections containing hydrocortisone (as sodium phosphate)
Drugs List
Therapeutic Indications
Uses
Adrenal insufficiency - cortical
Allergic reaction - severe
Anaphylaxis
Inflammatory or allergic conditions
Shock - adrenal crisis
Soft tissue lesion
Status asthmaticus
For rapid use in emergency situations involving the following conditions:
Status asthmaticus and acute allergic reactions, including anaphylactic reaction to drugs and angioedema. Hydrocortisone sodium phosphate supplements the action of adrenaline.
Severe shock arising from surgical or accidental trauma or overwhelming infection.
Acute adrenal insufficiency caused by stress in Addison's disease, hypopituitarism, following adrenalectomy, and when adrenocortical function has been suppressed by prolonged corticosteroid therapy.
Hydrocortisone sodium phosphate should not replace other forms of therapy for status asthmaticus and shock.
Hydrocortisone sodium phosphate may also be given for local effect in soft tissue lesions such as tennis elbow, tenosynovitis and bursitis.
Unlicensed Uses
Neonatal hypotension resistant to other treatment
Neonatal hypotension resistant to other treatment
Dosage
Adults
Systemic therapy in adults
100mg to 500mg given by slow intravenous injection over 30 seconds to 1 minute.
This can be repeated three or four times in 24 hours depending on the condition and patient's response.
It may also be given as an intravenous infusion or by intramuscular injection.
Local treatment of soft tissue lesions
100mg to 200mg. This dose can be repeated two to three times depending on patient response.
The following alternative dosing schedules may be suitable:
Adrenocortical insufficiency
100mg to 500mg intravenously or intramuscularly three or four times a day, or when required.
Adrenocortical insufficiency due to septic shock
50mg by intravenous injection every 6 hours, in combination with fludrocortisone.
Corticosteroid replacement
For patients who have taken more than 10mg prednisolone daily within three months of minor surgery under general anaesthesia:
25mg to 50mg intravenously at the induction of surgery. After surgery, give the patient's usual corticosteroid dose.
For patients who have taken more than 10mg prednisolone daily within three months of moderate of major surgery:
Initial dose: Give the patient's usual corticosteroid dose in the morning, then 25mg to 50mg intravenously at the induction of surgery.
Maintenance dose: 25mg to 50mg three times a day for 24 hours after moderate surgery and for 48 to 72 hours after major surgery.
Severe acute asthma
100mg by intravenous injection every 6 hours until conversion to oral prednisolone possible (in combination with other treatments).
Severe inflammatory bowel disease
100mg to 500mg intravenously three or four times a day, or when required.
Children
Systemic therapy in children
Children aged 6 to 12 years: 100mg intravenously.
Children aged 1 to 5 years: 50mg intravenously.
Children aged up to 1 year: 25mg intravenously.
This dose can be repeated three or four times in 24 hours depending on the condition and patient's response.
The following alternative dosing schedules may be suitable:
Acute adrenocortical insufficiency (Addisonian crisis)
Children aged 12 to 18 years
100mg every 6 to 8 hours by slow intravenous injection or infusion.
Children aged 1 month to 12 years
Initial dose: 2mg/kg to 4mg/kg as a slow intravenous injection or infusion.
Maintenance dose: 2mg/kg to 4mg/kg every 6 hours as a slow intravenous injection or infusion, titrated to patient response. Reduce over four to five days to oral maintenance dose when patient is stable.
Remission of inflammatory bowel disease
Children aged 2 to 17 years
2.5mg/kg (maximum of 100mg per dose) every 6 hours by intravenous injection.
OR
10mg/kg daily, up to 400mg per day, by continuous intravenous infusion.
Angioedema; Acute hypersensitivity reactions
Children aged 12 to 18 years: Initially, 200mg intravenously or intramuscularly, three times daily, titrated according to response.
Children aged 6 to 12 years: Initially, 100mg intravenously or intramuscularly, three times daily, titrated according to response.
Children aged 6 months to 6 years: Initially, 50mg intravenously or intramuscularly, three times daily, titrated according to response.
Children aged under 6 months: Initially, 25mg intravenously or intramuscularly, three times daily, titrated according to response.
Severe acute asthma
Children aged 5 to 18 years: 4mg/kg intravenously every 6 hours (maximum 100mg per dose). Alternatively, 100mg every 6 hours until conversion to oral prednisolone is possible.
Children aged 2 to 5 years: 4mg/kg intravenously every 6 hours (maximum 100mg per dose). Alternatively, 50mg every 6 hours until conversion to oral prednisolone is possible.
Children aged under 2 years: 4mg/kg intravenously every 6 hours (maximum 100mg per dose). Alternatively, 25mg every 6 hours until conversion to oral prednisolone is possible.
Hypotension resistant to inotropic treatment and volume replacement (limited evidence) (unlicensed)
1mg/kg (maximum 100mg per dose) every 6 hours by intravenous injection.
Neonates
Acute adrenocortical insufficiency (Addisonian crisis) (unlicensed)
Initial dose: 10mg as slow intravenous injection.
Maintenance dose: 100mg/metre squared daily, either as a continuous infusion or as an intravenous infusion in divided doses every 6 to 8 hours. Titrate to patient response. Reduce over four to five days to oral maintenance dose when patient is stable.
Hypotension resistant to inotropic treatment and volume replacement (limited evidence) (unlicensed)
Initial dose: 2.5mg/kg intravenously, repeated if necessary after 4 hours,
Maintenance dose: 2.5mg/kg every 6 hours for 48 hours or until blood pressure recovers. Reduce dose gradually over a period of at least 48 hours.
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 three 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 three 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 three 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 three weeks or less:
Patients who have had repeated courses of systemic corticosteroids, especially if taken for greater than three 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.
Administration
For intravenous injection, intravenous infusion, soft tissue injection or intramuscular injection
The preferred route for emergency use is by intravenous injection as this gives a faster response than intramuscular injection.
Other routes of administration are contraindicated.
Care must be taken not to inject directly into a tendon.
Contraindications
Recent head trauma
Uncontrolled systemic infection
Cerebrovascular accident
Precautions and Warnings
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Epileptic disorder
Gastrointestinal anastomosis
Glaucoma
Hepatic impairment
History of peptic ulcer
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Renal impairment
Severe affective disorders
Administration of live vaccines is not recommended
Consider increased dose during intercurrent illness/trauma/surgery
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
Passive immunisation of chicken pox / herpes zoster may be required
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
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
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
Maintain treatment at the lowest effective dose
Advise patient not to take St John's wort concurrently
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
Corticosteroids should not be used for the treatment of cerebral oedema associated with cerebrovascular accident or head injury, as they are unlikely to be of benefit and may cause harm.
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.
Although uncommon, peptic ulceration can occur with high dose short term corticosteroids and acid suppression prophylaxis may be considered.
Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.
Pregnancy and Lactation
Pregnancy
Use hydrocortisone sodium phosphate with caution in pregnancy.
Hydrocortisone readily crosses the placenta. Schaefer (2007) suggests 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.
Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.
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 sodium phosphate 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 breastfeeding. Schaefer recommends that prednisolone and methylprednisolone are the systemic corticosteroids of choice during breastfeeding.
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.
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
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Bruising
Candidiasis
Cognitive impairment
Confusion
Corneal thinning
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Dyspepsia
Emotional lability
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Flushing
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Hirsutism
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Impaired healing
Increased appetite
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Insomnia
Irritability
Leucocytosis
Mania
Menstrual disturbances
Negative calcium balance
Negative protein balance
Opportunistic infections
Osteoporosis
Papilloedema
Paraesthesia
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Pruritus
Psychological dependence
Psychosis
Recurrence of dormant tuberculosis
Scleral thinning
Sleep disturbances
Sodium/water retention
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Vertebral and long bone fractures
Weight gain
Withdrawal syndrome - see product information
Withdrawal Symptoms and Signs
Withdrawal symptoms may occur which include the following:
Acute adrenal insufficiency, hypotension and death.
Withdrawal syndrome:
Fever
Myalgia
Arthralgia
Rhinitis
Conjunctivitis
Itchy skin nodules
Loss of weight
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 2016
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: Hydrocortisone 100mg/ml or 500mg/5ml Injection. Amdipharm Mercury Company Limited. Revised October 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 September 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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