Generic name: tapentadol hydrochloride
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Nucynta safely and effectively. See full prescribing information for Nucynta.
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As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity.
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 not recommended.
NUCYNTA® may be given with or without food [see Clinical Pharmacology (12.3)].
No dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
No dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® should be used with caution in patients with moderate hepatic impairment. Treatment in these patients should be initiated at 50 mg with the interval between doses no less than every 8 hours (maximum of three doses in 24 hours). Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.