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Dexamethasone parenteral

Presentation

Injections of dexamethasone.

Drugs List

  • dexamethasone 3.3mg/ml solution for injection ampoule
  • dexamethasone 3.8mg/ml injection solution
  • dexamethasone 6.6mg/2ml injection
  • Therapeutic Indications

    Uses

    Adrenal insufficiency - cortical
    Cerebral oedema
    Cerebral oedema secondary to cerebral tumour
    Chemotherapy induced nausea and vomiting
    Coronavirus disease 2019 (COVID-19) - treatment
    Inflammatory or allergic conditions
    Shock - severe (adjunct)

    Unlicensed Uses

    Bacterial meningitis

    Dosage

    Individualise the dosage on the basis of the disease and the response of the patient. To minimise the risk of any side effects always use the lowest possible dosage adequate to control the disease process.

    In acute, life-threatening situations, administration of dosages exceeding the usual level may be justified. In these circumstances the slower rate of absorption by the intramuscular route should be noted.

    During prolonged therapy any inter-current illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced.

    Adults

    Usual initial dosage is in the range of 400micrograms to 16.6mg a day. Adjust both the dosage and the frequency interval slowly to achieve the lowest dosage, which will maintain an adequate clinical response.

    Treatment of haemorrhagic, traumatic or surgical shock
    1.7 to 5mg/kg body weight as a single intravenous injection given over several minutes. This may be repeated in 2 to 6 hours if shock persists.
    The initial bolus injection may be followed by 1.7 to 5mg/kg bodyweight per 24 hours given by an intravenous infusion (manufacturers recommend different dosages).
    Administration of these high dosages should be continued only until the time that the patient's condition has stabilised and usually not longer than 48 to 72 hours.

    Cerebral oedema associated to cerebral tumour
    Initially 8.3mg intravenously, followed by 3.3mg intramuscularly every 6 hours until symptoms of cerebral oedema subside.
    Response is usually noted within the first 24 hours and the dosage may be reduced after two to four days. Gradually discontinue the dosage over five to seven days. Patients with recurrent or inoperable tumours, maintenance therapy may be effective at doses of 1.7mg intramuscularly or intravenously two to three times daily.

    Cerebral oedema
    Initial dose: 8mg to 16mg intravenously.
    Maintenance dose: 5mg intravenously or intramuscularly every 6 hours until a satisfactory result has been obtained. These doses may be needed for several days post operation.

    Some manufacturers suggest the following high dosages of dexamethasone for initiating treatment in life-threatening cerebral oedema (see suggested doses below). After the first day of high dose administration the dose is scaled down over an eight day period of intensive therapy. Wherever possible convert the patient to oral dexamethasone as soon as possible.

    High dose schedule in life threatening cerebral oedema
    Initial dose: 41.5mg intravenously.
    First to third day: 6.6mg intravenously every 2 hours.
    Fourth day: 3.3mg intravenously every 2 hours.
    Fifth to eighth day: 3.3mg intravenously every 4 hours.
    Thereafter decrease daily dose by 3.3mg.

    Intrasynovial, Intralesional, and Soft Tissue Injection
    Dosage varies with degree of inflammation and the size and location of the affected area.
    Treatment may be once every three to five days (e.g. for bursae) to once every two to three weeks (for joints), depending upon the response. Dosage recommendations are:
    Large joint (e.g. knee): 1.6mg to 3.3mg.
    Small joint (e.g. interphalangeal, temporomandibular): 0.6mg to 0.8mg.
    Bursae: 1.6mg to 3mg.
    Tendon Sheaths (inject into tendon sheath, not directly into tendon): 0.3mg to 0.8mg.
    Soft Tissue Infiltration: 1.7mg to 5mg.
    Ganglia: 0.8mg to 1.7mg.

    Ulcerative Colitis
    4mg diluted in 120ml saline as a rectal drip instillation.

    Adjunctive Treatment of Bacterial Meningitis (unlicensed)
    10mg every 6 hours for four days by intravenous injection.

    Coronavirus disease 2019 (COVID-19)
    6mg once daily for up to 10 days by intravenous injection.

    Elderly

    The treatment of elderly patients particularly if long term, needs to be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypokalaemia, hypertension, susceptibility to infection and thinning of skin. Close clinical supervision is necessary to avoid life threatening reactions.

    Children

    Dosage requirements are variable. Usually 167 micrograms to 400 micrograms/kg body weight daily.
    To lessen retardation of growth and minimise suppression of the hypothalamic-pituitary-adrenal axis, dosage should be limited to a single dose on alternate days, where possible.

    High dose schedule in life threatening cerebral oedema
    Children 35kg and over
    Initial dose: 20.8mg intravenously.
    First to third day: 3.3mg intravenously every 2 hours.
    Fourth day: 3.3mg intravenously every 4 hours.
    Fifth to eighth day: 3.3mg intravenously every 6 hours.
    Thereafter, decrease daily dose by 1.7mg.

    Children under 35kg
    Initial dose: 16.6mg intravenously.
    First to third day: 3.3mg intravenously every 3 hours.
    Fourth day: 3.3mg intravenously every 6 hours.
    Fifth to eighth day: 1.7mg intravenously every 6 hours.
    Thereafter decrease daily dose by 0.83mg.

    Adjunctive Treatment in Bacterial Meningitis (unlicensed)
    Children aged 3 months to 16 years
    150 micrograms/kg every 6 hours for four days starting before or with the first dose of antibacterial.
    Maximum dose: 10mg

    Children aged 16 to 18 years
    10mg every 6 hours for four days.

    Coronavirus disease 2019
    Children aged 12 to 18 years old weighing at least 40kg
    6mg once daily for up to 10 days by intravenous injection.

    The following dosage schedule may also be suitable:

    Inflammatory or Allergic Disorders
    Children aged 12 years to 18 years
    Initial dose: 400 micrograms to 20mg daily by intravenous injection, intravenous infusion or intramuscular injection.

    Children aged 1 month to 12 years
    Maintenance dose: 83 to 333 microgram/kg, given in 1 or 2 divided doses daily.
    Maximum dose: 20mg daily.

    Adrenal Insufficiency
    250 to 500 micrograms/squared metre 12 hourly as required.

    Coronavirus disease 2019
    Children aged 1 month to 18 years (unlicensed)
    150 micrograms/kg once daily for 10 days. Maximum 6mg once daily.

    Additional Dosage Information

    Dexamethasone withdrawal
    Adrenal cortical atrophy develops during prolonged therapy and may persist for many years after stopping treatment.

    Too rapid a reduction of corticosteroid dosage following prolonged therapy can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication where continuous therapy is given.

    Patients receiving doses greater than approximately 1mg of dexamethasone daily (approximately normal physiological levels) for more than 3 weeks should be withdrawn gradually. Reduction method will depend on the likelihood of disease relapse during dose reduction. Clinical assessment of disease activity may be required during withdrawal. If relapse is unlikely but there is uncertainty about HPA suppression, the dose may be reduced rapidly to 1mg dexamethasone and then reduced more slowly to allow HPA-axis recovery.

    If relapse is unlikely and up to 6mg dexamethasone has been given for less than 3 weeks then abrupt withdrawal is unlikely to result in clinically relevant HPA-axis suppression in the majority of patients.

    Even after less than 3 weeks treatment, gradual withdrawal should be considered in the following patient groups:
    Patients who have had repeated systemic steroid courses especially if courses were for longer than 3 weeks.
    When a short course has been prescribed within one year of stopping a course that had lasted for months or years.
    Patients at risk of adrenocortical insufficiency other than exogenous corticosteroid therapy.
    Patients receiving doses greater than 6mg daily of dexamethasone.
    Patients repeatedly taking doses in the evenings.

    Administration

    Administration may be by the intravenous, subcutaneous, intramuscular, intra-articular or soft tissue injection or by rectal drip.

    Intravenous administration enables high plasma levels to be obtained rapidly. The injection should be given slowly over a period of several minutes.

    Contraindications

    Administration site infection
    Uncontrolled systemic infection

    Precautions and Warnings

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

    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 activate latent amoebiasis
    May mask symptoms or signs of infections
    Not all available brands are licensed for all indications
    Not all available brands are licensed for all routes of administration
    Some formulations contain propylene glycol
    Some preps may contain sulfite; caution hypersensit. in asthma/allergy pts
    Frequent review needed to titrate dose to disease activity
    If visual disturbances occur, perform ophthalmic evaluation
    Monitor patients at risk of tumour lysis syndrome
    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
    Consider septic arthritis post joint inj if pain,fever,swelling occur
    Corticosteroids may cause growth retardation in children under 18 years
    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
    Advise patient not to take St John's wort concurrently
    Advise patients to avoid aspirin and NSAID use
    Advise patient to rest treated joint after intra-articular injection
    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

    Divided dosage regimes and evening administration have been associated with an increased suppression of the hypothalamic-pituitary-adrenal axis.

    Dexamethasone may exacerbate systemic fungal infections and should not be used unless they are needed to control 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 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 upward dosage adjustment may be required.

    Some formulations of dexamethasone 3.3 mg/ml injection contain a significant amount of propylene glycol. Neonates, children under 5 years and patients with renal or hepatic impairment should use these products with caution. Serious adverse reactions may occur if the propylene glycol safety threshold is exceeded, particularly in neonates and infants. Monitoring for propylene glycol toxicity is recommended.

    Pregnancy and Lactation

    Pregnancy

    Use dexamethasone with caution during pregnancy.

    The manufacturer advises dexamethasone is used only if the benefits to the mother outweigh the potential risk to the foetus. However, if corticosteroids are considered essential, patients with normal pregnancies may be treated as though they were in the non-gravid state. The lowest effective dose required to maintain adequate disease control should be used.

    Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out. Dexamethasone readily crosses the placenta, foetal serum concentrations are similar to maternal concentrations.

    Administration for prolonged periods or repeatedly during pregnancy may increase the risk of intra-uterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids. However this will usually resolve following birth and is rarely clinically significant.

    Lactation

    Use dexamethasone with caution during breastfeeding.

    The manufacturer states that corticosteroids are excreted into breast milk and may interfere with endogenous corticosteroid production and cause other undesirable effects. Infants of mothers receiving prolonged high dose corticosteroid therapy may experience a degree of adrenal suppression.

    Side Effects

    Abdominal distension
    Acne
    Acute pancreatitis
    Aggravation of schizophrenia
    Allergic dermatitis
    Amenorrhoea
    Amnesia
    Anaphylaxis
    Anxiety
    Aseptic necrosis
    Avascular osteonecrosis
    Behavioural disturbances
    Bronchospasm
    Bruising
    Candidiasis
    Charcot-like arthropathy
    Chorioretinopathy
    Cognitive impairment
    Confusion
    Convulsions
    Corneal thinning
    Cushingoid changes
    Delusions
    Depression
    Dyspepsia
    Ecchymosis
    Emotional lability
    Euphoria
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Exophthalmos
    Fluid retention
    Glaucoma
    Hallucinations
    Headache
    Hirsutism
    Hyperpigmentation
    Hypersensitivity reactions
    Hypertension
    Hypokalaemia
    Hypokalaemic alkalosis
    Hypopigmentation
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Impairments of sperm parameters
    Increased appetite
    Increased intra-ocular pressure
    Increased susceptibility to infection
    Increased sweating
    Injection site reactions
    Irregular menstruation
    Irritability
    Joint destruction
    Leucocytosis
    Mania
    Muscle weakness
    Myocardial rupture
    Negative calcium balance
    Negative nitrogen balance
    Negative protein balance
    Opportunistic infections
    Osteoporosis
    Papilloedema
    Peptic ulceration with perforation and haemorrhage
    Petechiae
    Post-injection flare
    Posterior subcapsular cataracts
    Premature closure of epiphyses
    Proximal myopathy
    Psychiatric disorders
    Psychological dependence
    Raised intracranial pressure
    Recurrence of dormant tuberculosis
    Reduced muscle mass
    Scleral thinning
    Sleep disturbances
    Sodium/water 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

    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: December 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: Dexamethasone 3.8 mg/ml solution for injection. Aspen Pharma Trading Ltd. Revised November 2018.

    Summary of Product Characteristics: Dexamethasone 3.3 mg/ml solution for injection. Hameln Pharmaceuticals Ltd. Revised February 2021.

    Summary of Product Characteristics: Dexamethasone 3.3 mg/ml solution for injection (vial). Hospira UK Ltd. Revised July 2019.

    Summary of Product Characteristics: Dexamethasone 3.3 mg/ml solution for injection (ampoule). Hospira UK Ltd. Revised January 2019.

    Summary of Product Characteristics: Dexamethasone 3.3 mg/ml solution for injection or infusion. Wockhardt UK Ltd. Revised March 2017.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 October 2022

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Dexamethasone. Last revised: 31 October 2018
    Last accessed: 07 November 2019

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