Off-Label Use of Ciprofloxacin/Dexamethasone Drops in the Pediatric Upper Airway: Case Presentation and Review of Adverse Effects

Abstract

Objective: This report describes a new observation of hyperglycemia in a child with Type 1 diabetes after off-label use of otic ciprofloxacin/dexamethasone drops in the nasal passage and reviews previous reports of adverse endocrine effects from intranasal corticosteroids in pediatric patients. Methods: We describe the clinical case and conducted a literature review of MEDLINE (PubMed) and EMBASE. Results: A 9-month-old female with a history of Type 1 diabetes who underwent unilateral choanal atresia repair was started on 1 week of ciprofloxacin 0.3%/dexamethasone 0.1% otic drops twice a day for choanal obstruction with granulation tissue. While the patient’s airway patency improved, average daily blood glucose increases by 40 to 50 points were noted on the patient’s continuous glucose monitor. The hyperglycemia resolved within 2 days after switching to mometasone furoate 0.05% spray. We also review 21 pediatric otolaryngology cases of iatrogenic Cushing’s syndrome associated with on- and off-label use of topical steroid suspensions in the airway. Patients ranged from 3 months to 16 years in age and used doses of 50 μg/day to 2 mg/day. Conclusion: This is the first reported pediatric case of increased blood glucose levels associated with intranasal steroid suspensions, to the best of our knowledge. Counseling families on precise dose administration and potential endocrine disturbances is critical when prescribing these medications for off-label use in infants and small children, particularly among patients with underlying endocrine disorders such as diabetes.

Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists

“…Ben-Dov et al reported the use of CPD off-label to prevent postoperative granulation after choanal atresia repair in an infant. 15 One potential explanation for the limited data on the use of CPD or other nebulized antibiotic-steroid combinations may be that because these medications are so effective that clinicians may not feel comfortable omitting their use solely for research purposes. Given this, our survey results provide insights into the numerous indications for which pediatric otolaryngologists are commonly using CPD off-label.…”

“…The second most common indication was choanal atresia, reported by 82.1% of respondents. Ben‐Dov et al reported the use of CPD off‐label to prevent postoperative granulation after choanal atresia repair in an infant 15 . One potential explanation for the limited data on the use of CPD or other nebulized antibiotic‐steroid combinations may be that because these medications are so effective that clinicians may not feel comfortable omitting their use solely for research purposes.…”

“…In reviewing the safety of intranasal steroid drops and sprays in children, Ben-Dov et al found that most AEs involved hyperglycemia and Cushing's syndrome. 15 These were more likely to occur in very young children or in those who received a prolonged course (months to years) of steroid application. Nasal drops can have some systemic absorption that may be increased in young children, especially when drops are administered lying down because the drops are not only absorbed in the respiratory tract but also swallowed.…”

“…Nasal drops can have some systemic absorption that may be increased in young children, especially when drops are administered lying down because the drops are not only absorbed in the respiratory tract but also swallowed. 15 Ben One challenge in accessing off-label CPD that the authors encountered at our institution was pharmacy's concern regarding the preservative benzalkonium chloride (BAC), which has been found to cause bronchoconstriction and may have a potential risk of pneumonia and UTIs. However, in our review of the literature, a study of BAC found that the concentration required to decrease FEV 1 by 20% was 6.93 mg/mL.…”

“…-Dov et al discuss hyperglycemia as a rare, but potential complication in the literature; they describe one infant with type 1 diabetes whose blood glucose increased by 40-50 points while on intranasal CPD drops (1 drop twice daily for 1 week; FDA labeling 5 states four drops of CPD (0.14 mL) comprises 0.42 mg ciprofloxacin and 0.14 mg dexamethasone) 15. Ben-Dov et al did not investigate tracheal or nebulized CPD.…”