Off Label Medication

Pharmacotherapy in pediatric patients often includes use of approved and unapproved (off-label) drugs. Off-label use of medication is the use of a drug outside of its approved labeled indication. This includes the use of a medication in the treatment of illnesses not listed on the manufacturer's package insert, use outside the licensed age range, dosing outside those recommended, or use of a different route of administra-tion.41 Such off-label use in infants and children is frequently based on limited data.

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