Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
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.