1.2. Pediatrics

Tramadol IR is FDA-approved for use to manage acute and chronic moderate to moderately severe pain in adolescents 17 years of age and older. Following a titration phase, recommended IR tramadol regimens for pain management include doses of 50 mg to 100 mg administered every 4 to 6 hours as needed. Tramadol ER and tramadol/acetaminophen combination therapy are not FDA-approved for use in pediatric patients as safety and efficacy have not been established and the potential exists for an increased risk of fatal respiratory depression. Pediatric tramadol dosages are summarized in Table 3.