"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
- Patient Information:
Details with Side Effects
NUCYNTA® (tapentadol) is indicated for the management of moderate to severe acute pain in adults.
DOSAGE AND ADMINISTRATION
Individualization of Dosage
As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of tapentadol, give attention to the following:
- the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
- the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed;
- the patient's degree of opioid tolerance;
- the general condition and medical status of the patient;
- concurrent medications;
- the type and severity of the patient's pain;
- risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving tapentadol is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy.
During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family. Monitor the patient for signs of respiratory or central nervous system depression.
Initiation of Therapy
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.
The safety and efficacy of NUCYNTA® has not been studied in patients with severe hepatic impairment (Child-Pugh Score 10-15) and use in this population is not recommended [see WARNINGS AND PRECAUTIONS].
Initiate treatment of patients with moderate hepatic impairment (Child-Pugh Score 7 to 9) with 50 mg no more frequently than once 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].
No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see CLINICAL PHARMACOLOGY].
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.
Cessation of Therapy
When the patient no longer requires therapy with tapentadol, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient [see WARNINGS AND PRECAUTIONS].
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) [see DESCRIPTION and 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).
Storage and Handling
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 NUCYNTA® in a secure place out of reach of children.
NUCYNTA® tablets that are no longer needed should be destroyed by flushing down the toilet.
Manufactured by: Janssen Ortho, LLC Gurabo, PR 00778. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Revised: July 2013
Last reviewed on RxList: 7/24/2013
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.