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Drug dosage identifier

Dexamethasone Sodium Phosphate

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Dose and administration

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For Chronic Lung Disease

The use of Dexamethasone may be considered in infants who are:

  • Requiring mechanical ventilation between 7 and 21 days of age,
  • In supplemental oxygen, and
  • At high risk of neonatal Chronic Lung Disease (CLD)

The recommended course for use in National Women's Health is the course used in the DART trial1. Parental consent after explanation of the potential benefits and risks of treatment will be documented in the clinical notes.

Time Dose Frequency
Day 1 to 3 0.075mg/kg/dose 12-hourly
Day 4 to 6 0.050mg/kg/dose 12-hourly
Day 7 and 8 0.025mg/kg/dose  12-hourly
Day 9 and 10 0.01mg/kg/dose 12-hourly
  • Some individuals may receive subsequent doses of 0.01mg/kg/day every 2-3 days if there is significant deterioration after the tapering of the dose on day 10.
  • Repeat courses may be indicated in selected infants with severe CLD.

For subglottic oedema

  • 0.25 mg/kg/dose IV, PO 8 hourly for 3 doses. First dose administered approximately 4 hours before the scheduled extubation.

Indications

  • To improve lung function and facilitate extubation in infants requiring prolonged mechanical ventilation or supplementary oxygen.
  • Subglottic oedema.

Contraindications and precautions

  • Known hypersensitivity to corticosteroids and/or dexamethasone.
  • Caution in acute infection, especially systemic fungal infections.
  • Caution with positive sputum cultures for Candida albicans.
  • Caution in gastrointestinal ulceration and renal disease.

Interactions

  • Barbiturates, phenytoin and rifampin decrease corticosteroid effect.
  • Indomethacin increases the risk of GI bleeding.
  • May decrease the antibody response to vaccines.

Clinical pharmacology

Dexamethasone is a synthetic adrenocortical steroid possessing basic glucocorticoid actions and effects. It is among the most active members of its class, being about 25-30 times as potent as hydrocortisone. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium retaining property of hydrocortisone and closely related derivatives of hydrocortisone. Dexamethasone is readily absorbed from the gastrointestinal tract. The plasma half-life is 3-4 hours but the biological half-life is 36-54 hours. The metabolic clearance of dexamethasone is enhanced by the concurrent administration of phenobarbitone, phenytoin, and other drugs that induce hepatic enzyme function. Elimination in urine and bile.

Pharmacological effects of dexamethasone are numerous and predominantly affect metabolism, including glucose homeostasis, promoting catabolism, suppression of the hypothalamus-pituitary-adrenal axis, suppression of growth. The potential benefits of dexamethasone on respiratory function may be mediated through a reduction of bronchial and pulmonary oedema, bronchospasm, reduced inflammation (through inhibition of prostaglandin and leukotriene synthesis, increased antioxidant activity, and cell membrane stabilisation).

Possible adverse effects

  • Increased susceptibility to and suppression of the usual symptoms and signs of infection.
  • Glucose metabolism: hyperglycaemia, glycosuria.
  • Cardiovascular: hypertension, myocardial hypertrophy.
  • Electrolyte disturbances: sodium and water retention, hypokalaemia and hypocalcaemia.
  • Gastrointestinal: haemorrhage, gastric ulceration and duodenal perforation.
  • Haematological: Leukocytosis, neutrophilia, monocytopaenia, lymphopaenia, eosinopaenia
  • Skin: Thin fragile skin, impaired wound healing
  • Renal: Nephrocalcinosis, nephrolithiasis
  • Musculo-skeletal: myopathy, osteopenia.
  • Posterior subcapsular cataracts
  • Cessation of linear growth
  • Benign raised intracranial pressure
  • Suppression of adrenal glands (HPA axis)

Special consideration

  • Several regimens for the use of dexamethasone in chronic lung disease have been described in the literature. They may be classified as short, intermediate or long. At present there are few comparative data recording the efficacy and safety of these regimens.
  • Biochemical and haematological disturbances are common. Urea, electrolytes, glucose and WBC should be monitored frequently.
  • Use cautiously with potassium-depleting diuretic therapy.
  • Suppression of the HPA axis occurs if dexamethasone is used for longer than one week. Acute adrenal insufficiency may occur if dexamethasone is abruptly discontinued. Infants who have received dexamethasone for more than one week must be weaned over a period of several days.
    • Infants who deteriorate during the weaning phase of their course of dexamethasone, or shortly after discontinuing dexamethasone, may benefit from additional dexamethasone.
    • Infants undergoing surgery while receiving dexamethasone must have their dose increased during the perioperative period.
  • There have been recent concerns about potential long-term adverse neurodevelopmental effects in preterm infants exposed to postnatal steroids for treatment or prevention of chronic lung disease.7 The DART study ceased early due to slow recruitment but did not show a significant differences in the primary outcome of survival without disability between the dexamethasone and placebo groups.
  • Systematic reviews have demonstrated that moderately early (7-14 days) steroid use is associated with a reduction in mortality and in the incidence of CLD.8 Similar reductions in these outcomes are seen with early (<96 hours of age) steroids.9 Delayed (>21 days) steroid use is not associated with increased survival but there may be a reduction in CLD.10
  • The reviews of early 9 and delayed 10 steroids have also raised concerns about long-term outcomes, which are more common in steroid treated infants. There are insufficient data regarding the long-term outcomes with moderately early steroid use. However, there may be a decreased risk of neurodevelopmental problems when steroids are used in infants at high risk of CLD.12

Management of Dexamethasone administration 

Description

  • Clear colourless solution 4 mg/ml for IV, IM use. No preservatives. Contains sodium citrate 10mg/ml and disodium edetate 0.5mg/ml
  • Oral suspension - white 1 mg/ml (concentration can be adjusted to individual needs).

Prescription

  • Maintenance doses are charted on prescription chart in mg/dose.
  • The entire course is prescribed in advance.
  • Tapering doses are prescribed as indicated.

Administration

Slow IV Push

  1. Dilution not required. For dose volumes <0.05 ml dilute to 1mg/ml immediately prior to use by adding to NS or D5W.
  2. Filter prior to administration through a 0.2 micron filter.
  3. Administer by slow IV injection over 1-2 minutes.
  4. Compatible with D5W and NS.
  5. Do NOT mix with other drugs, IV solution, blood or blood products.
  6. Flush line with NS before and after administration of dexamethasone.

Oral

  1. Shake the bottle well. This mixture is in suspension, therefore the ingredients will settle to the bottom of the bottle on standing.
  2. Administer after milk.
  3. When dose is <0.05 ml dilute to 1 mg/5 ml.
  4. Measure 1 ml of dexamethasone oral suspension 1 mg/ml. Dispense this into an empty 5 ml syringe.
  5. Measure 4 ml of water for injection and add this to the measured dexamethasone.
  6. Mix well.
  7. Draw dose from this.
  8. Discard after use.

Nursing considerations

  • Observe for signs of adverse reactions.
  • Monitor blood pressure 2-3 times daily.
  • Test for glycosuria daily. If urine is positive for sugar, check each urine.
  • Observe gastric aspirates and stools for bleeding.
  • Observe closely for signs of infection.

Storage

IV Solution Oral suspension
Store at room temperature <25°C Unopened - store in the refrigerator until expiry
Protect from light and freezing Opened - Expires 7 days from opening
Storage after use nil  

References

  1. Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB, and the DART study invetigators. Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial. Pediatrics 2006;117:75-83.
  2. Cummings JJ, D'Eugenio DB, Gross SJ. A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia. N Engl J Med 1989; 320:1505-10.
  3. Durand M, Sardesai S, McEvoy C. Effects of early dexamethasone therapy on pulmonary mechanics and chronic lung disease in very low birthweight infants: A randomised controlled trial. Pediatrics 1995; 95:584-590.
  4. Collaborative Dexamethasone Trial Group: Dexamethasone therapy in neonatal chronic lung disease: An international placebo-controlled trial. Paediatrics 1991; 88:421-7.
  5. Rizi ZB, Aniol HS, Myers TF, Zelter WP, Fisher SG, Anderson CL. Effects of dexamethasone on the hypothalamic - pituitary - adrenal axis in preterm infants. J Pediatr 1992; 120:961-5
  6. Couser RJ, Ferrara B, Falde B, Johnson K, Schilling CG, Hoekstra RE. Effectiveness of dexamethasone in preventing extubation failure in preterm infants at increased risk for airway oedema. J Pediatr 1992; 121:591-6.
  7. Doyle LW, Davis PG. Postnatal corticosteroids in preterm infants: systematic review of effects on mortality and motor function. J Paediatr Child Health 2000; 36(2): 101-107.
  8. Halliday HL , Ehrenkranz RA. Moderately early (7-14 days) postnatal corticosteroids for preventing chronic lung disease in preterm infants (Cochrane Review). In: The Cochrane Library, Issue 3, 2000. Oxford: Update Software.
  9. Halliday HL , Ehrenkranz RA. Early postnatal ( <96 hours) corticosteroids for preventing chronic lung disease in preterm infants (Cochrane Review). In: The Cochrane Library, Issue 3, 2000. Oxford: Update Software.
  10. Halliday HL , Ehrenkranz RA. Delayed ( >3 weeks) postnatal corticosteroids for chronic lung disease in preterm infants (Cochrane Review). In: The Cochrane Library, Issue 3, 2000. Oxford: Update Software.
  11. Odd DE, Armstrong DL, Teele RL, Kuschel CA, Harding JE. A randomized trial of two dexamethasone regimens to reduce side-effects in infants treated for chronic lung disease of prematurity. J Paediatr Child Health 2004;40:282-9.
  12. Doyle LW. Halliday HL. Ehrenkranz RA. Davis PG. Sinclair JC. Impact of postnatal systemic corticosteroids on mortality and cerebral palsy in preterm infants: effect modification by risk for chronic lung disease. Pediatrics 2005;115(3):655-61.

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Document Control

  • Date last published: 26 January 2005
  • Document type: Drug Dosage Guideline
  • Services responsible: ADHB Pharmacy, Neonatology
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years