BB is now older (6 months corrected age) and his mother calls the clinic and tells you that her son is "just miserable" with a runny nose, cough, and a fever (axillary temperature) of 38.3°C (101°F). She wanted to know if she could use baby aspirin instead of the acetaminophen, which doesn't seem to help. She also wanted to know which cough and cold preparation would be most appropriate for BB.
What additional information would you need to help BB and his mom?
What is your recommendation regarding use of aspirin for BB?
What cough and cold preparation would you recommend for BB?
Currently, there is a lack of pediatric dosing, safety, and efficacy information for over 75% of drugs approved in adults. Off-label use occurs in both outpatient and inpatient settings. About 80% of hospitalized pediatric patients receive at least one offlabel medication.42 It is appropriate to use a drug off-label when no alternatives are available; however, clinicians should refer to published studies and case reports for available safety, efficacy, and dosing information. FDA regulatory changes, such as patent exclusivity, provide incentives for a pharmaceutical manufacturer to market drugs for pediatric patients.
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