"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
NUCYNTA® (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
DOSAGE AND ADMINISTRATION
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].
No dosage adjustment is recommended in patients with mild or moderate renal impairment [see CLINICAL PHARMACOLOGY].
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].
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].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see WARNINGS AND PRECAUTIONS].
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.
Dosage Forms And Strengths
NUCYNTA® Tablets are round, biconvex and film-coated and are available in the following strengths, colors, and debossings: 50 mg of tapentadol (yellow with “O-M” on one side and “50” on the other side), 75 mg of tapentadol (yellow-orange with “O-M” on one side and “75” on the other side), and 100 mg of tapentadol (orange with “O-M” on one side and “100” on the other side).
Storage And Handling
NUCYNTA® Tablets are available in the following strengths and packages. All tablets are round and biconvex-shaped.
50 mg tablets are yellow and debossed with “O-M” on one side and “50” on the other side, and are available in bottles of 100 (NDC 50458-820-04) and hospital unit dose blister packs of 10 (NDC 50458-820-02).
75 mg tablets are yellow-orange and debossed with “O-M” on one side and “75” on the other side, and are available in bottles of 100 (NDC 50458-830-04) and hospital unit dose blister packs of 10 (NDC 50458-830-02).
100 mg tablets are orange and debossed with “O-M” on one side and “100” on the other side, and are available in bottles of 100 (NDC 50458-840-04) and hospital unit dose blister packs of 10 (NDC 50458-840-02).
Store up to 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Keep out of reach of children.
Revised: July 2011. Manufactured by: Janssen Ortho, LLC, Gurabo, PR 00778. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Rev: July 2011
Last reviewed on RxList: 11/20/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.