Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

Table 1

Off-label medicine use categories.

Sr. number	Category	Reason for off-label use	Examples based on NFI.
1	Dose	Dose higher than recommended	Once daily dosing of gentamicin in children
2	Age	Drug not recommended in the patient below a certain age	Losartan used in children under 6 years
3	Indication	Drug prescribed for indications outside of those listed in the NFI	Diclofenac for abdominal pain
4	Route of administration	Drug administered by a route not described in the NFI	Adrenaline through inhalation route
5	Absence of pediatric information (PI)	No mention at all in the NFI regarding pediatric use	Nifedipine for hypertension

NFI: National Formulary of India, 2011 [10].