1.1. Adults

Tramadol is a centrally acting, opioid-type analgesic that acts as a mu-opioid receptor agonist and a weak inhibitor of serotonin and norepinephrine reuptake. The immediate-release (IR) formulation is FDA-approved for use in the management of acute or chronic moderate to moderately severe pain in adults2-4. Tramadol extended-release (ER) is FDA-approved for use in managing chronic moderate to moderately severe pain in patients requiring continuous pain management2,3,5. The tramadol/acetaminophen combination is FDA-approved for the acute (less than 5 days) management of acute pain2,3,6. 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. For tramadol ER, the recommended initial dose in tramadol IR-naïve patients is 100 mg once daily, titrated every five days in 100 mg increments until pain relief is achieved. For those patients already managed on tramadol IR, the 24-hour dose should be calculated, and the total daily tramadol ER dose should be rounded down to the closest 100 mg increment. The recommended dose for tramadol in combination with acetaminophen is 2 tablets every 4 to 6 hours as needed for pain relief2-6. Maximum recommended doses for tramadol alone and in combination with acetaminophen are summarized in Tables 1 and 2. Dosages exceeding these recommendations will be reviewed.

Table 1: Maximum Recommended Adult Oral Tramadol Dosages: Monotherapy2-5
Drug Name Dosage Forms/Strengths Maximum Recommended Dose
tramadol immediate-release (Ultram®, generics) 50 mg tablets

400 mg/day, in divided doses every 4-6 hours

elderly*: 300 mg/day, in divided doses every 4-6 hours
tramadol extended-release (generics) 100 mg, 200 mg, 300 mg tablets 300 mg/day in single daily doses
tramadol extended-release (ConZip®, generics) 100 mg, 150 mg, 200 mg, 300 mg capsules 300 mg/day in single daily doses

Legend

  • * = greater than 75 years of age
Table 2: Maximum Recommended Adult Oral Tramadol Dosages: Combination Therapy2,3,6
Drug Name Dosage Forms/Strengths Maximum Recommended Dose
tramadol/acetaminophen (Ultracet®, generics) 37.5 mg/325 mg tablets 300 mg/2600 mg per day (8 tablets per day), in divided doses every 4-6 hours