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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pain
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)
Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to tapentadol extended release.
Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).
Renal Dose Adjustments
Mild to moderate renal impairment: No adjustment recommended
Severe renal impairment: Not recommended
Liver Dose Adjustments
Mild hepatic impairment (Child-Pugh 5 to 6): No adjustment recommended
Moderate hepatic impairment (Child-Pugh 7 to 9):
Initial dose (immediate-release): 50 mg orally no more frequently than once every 8 hours (maximum of three doses in 24 hours). Shortening or lengthening the dosing interval should be used to maintain analgesia.
Initial dose (extended-release): Manufacturer recommends reducing the initial dose.
Severe hepatic impairment Child-Pugh 10 to 15): Not recommended
Data not available
Tapentadol dose should be based on an individual patient basis according to severity of pain, previous medication treatment, and ability to monitor patient.
Once the patient is stable on immediate release tablets and no further dose adjustments are required, consideration should be given to the possibility to switching the patient to the prolonged release tablets.
Sudden discontinuation of tapentadol treatment should be avoided to reduce withdrawal symptoms. Discontinuation of tapentadol treatment should be gradual.
Tapentadol should be taken with sufficient liquid with or without food. Tapentadol prolonged release tablets should be swallowed whole and not split or chewed.
Tapentadol treatment should be reviewed on a regular basis.