Related Experiment Video
Updated: Apr 25, 2026

A Minimally Invasive Method for Intratracheal Instillation of Drugs in Neonatal Rodents to Treat Lung Disease
Published on: August 4, 2021
Off-label use of drugs in neonatal intensive care units
Suksham Jain1, Shiv Sajan Saini, Deepak Chawla
1Departments of Pediatrics, Government Medical College Hospital, Chandigarh; and *Post Graduate institute of Medical Education and Research, Chandigarh; India. Correspondence to: Dr Suksham Jain, Associate Professor Paediatrics, GMCH, Chandigarh, India. dr.sukshamj@gmail.com.
Objective:
To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications.
Methods:
Chart audit in neonatal intensive care units of two institutions in Chandigarh, India.
Results:
Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates.
Conclusion:
Use of off-label drugs is common in sick neonates.
Related Concept Videos
Drug Dosing: Infants and Children
Pharmacokinetics in Pediatric Patients: Drug Excretion
Prescription, Nonprescription and Orphan Drugs
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Pharmacokinetics in Pediatric Patients: Drug Distribution
Factors Affecting Drug Response: Overview
Drug Delivery: Parenteral Route
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...

