1 mg/kg IV every 8 to 12 hours for 1 to 5 days has been studied in premature and term neonates (combined n from 3 studies = 89, gestational age 23 to 40 weeks). An initial loading dose of 2 mg/kg IV was used in 1 retrospective study and another prospective, observational study used a higher maintenance dose of 3 to 6 mg/kg/day IV divided 2 to 4 times daily in a small number of patients (n = 5) with severe capillary leak syndrome and/or previous steroid treatment. In the largest prospective, randomized, placebo controlled study (n = 48, gestational age to weeks), patients receiving hydrocortisone 1 mg/kg IV every 8 hours for 5 days required significantly less vasopressor support (lower doses of dopamine and dobutamine, shorter duration of vasopressor therapy, and fewer patients requiring more than 1 vasopressor) compared to patients receiving placebo. The trend of the average mean arterial blood pressure (MAP) was also significantly higher in patients receiving hydrocortisone compared to patients receiving placebo.
Orally administered deflazacort appears to be well absorbed and is immediately converted by plasma esterases to the pharmacologically active metabolite (D 21-OH) which achieves peak plasma concentrations in to 2 hours. It is 40% protein-bound and has no affinity for corticosteroid-binding-globulin (transcortin). Its elimination plasma half-life is to hours. Elimination takes place primarily through the kidneys; 70% of the administered dose is excreted in the urine. The remaining 30% is eliminated in the faeces. Metabolism of D 21-OH is extensive; only 18% of urinary excretion represents D 21-OH. The metabolite of D 21-OH, deflazacort 6-beta-OH, represents one third of the urinary elimination.
In a study of asthmatic children 5-12 years of age, those treated with budesonide administered via a dry powder inhaler 200 mcg twice daily (n=311) had a -centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. By the end of four years, children treated with the budesonide dry powder inhaler and children treated with placebo had similar growth velocities. Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study. The growth of pediatric patients receiving inhaled corticosteroids, including Pulmicort RESPULES, should be monitored routinely (., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks and benefits associated with alternative therapies. To minimize the systemic effects of inhaled corticosteroids, including Pulmicort RESPULES, each patient should be titrated to his/her lowest effective dose [see Dosage and Administration (2) , Warnings and Precautions () ] .