Nucynta ER Dosage
Generic name: tapentadol hydrochloride
Dosage form: tablet, film coated, extended release
This dosage information does not include all the information needed to use Nucynta ER safely and effectively. See full prescribing information for Nucynta ER.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Selection of patients for treatment with NUCYNTA® ER is governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization and Federation of State Medical Boards Model Guidelines.
NUCYNTA® ER tablets must be swallowed whole and must not be split, broken, chewed, dissolved, or crushed. Taking split, broken, chewed, dissolved, or crushed NUCYNTA® ER Tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol.
NUCYNTA® ER tablets must be taken one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].
Initiating Therapy with NUCYNTA® ER
It is critical to initiate the dosing regimen for each patient individually giving attention to:
- risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression;
- the age, general condition and medical status of the patient;
- the patient's opioid exposure and opioid tolerance (if any);
- the daily dose, potency, and kind of the analgesic(s) the patient has been taking;
- the balance between pain management and adverse reactions.
Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see Serotonin Syndrome Risk (5.10)]. Although the maximum approved total daily dose of NUCYNTA® immediate-release formulation is 600 mg per day, the maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed a total daily dose of NUCYNTA® ER of 500 mg.
Once therapy with NUCYNTA® ER is initiated, assess pain intensity and adverse reactions frequently.
Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three days.
During periods of changing analgesic requirements, including initial titration, maintain frequent contact between the healthcare provider and the patient.
Patients Currently Not Taking Opioid Analgesics
The starting dose of NUCYNTA® ER in patients currently not taking opioid analgesics is 50 mg twice a day (approximately every 12 hours). Individually titrate the dose within the therapeutic range of 100 mg to 250 mg twice daily.
Patients Currently Taking Opioid Analgesics
There are no adequate data on the direct conversion from other opioids to NUCYNTA® ER.
The initial dose of NUCYNTA® ER in patients previously taking other opioids is 50 mg titrated to an effective and tolerable dose within the therapeutic range of 100 mg to 250 mg twice daily.
In the dose selection of NUCYNTA® ER in patients currently taking opioids, give attention to the following:
- There is a substantial patient variation in the relative potency of different opioid drugs and formulations;
- It is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
- The recommended doses are only a starting point, and close observation and titration are indicated until a satisfactory dose is obtained on the new therapy.
Conversion from NUCYNTA® to NUCYNTA® ER
Patients can be converted from NUCYNTA® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTA® and dividing it into two equal doses of NUCYNTA® ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTA® four times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day.
Cessation of Therapy
Periodically reassess the continued need for NUCYNTA® ER during chronic therapy. When discontinuing NUCYNTA® ER, potential withdrawal symptoms may be reduced by tapering the dose of NUCYNTA® ER [see Withdrawal (5.11, 9.3)].
NUCYNTA® ER has not been studied in patients with severe renal impairment; therefore, the use of NUCYNTA® ER in this population is not recommended. No dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® ER has not been studied in patients with severe hepatic impairment. The use of NUCYNTA® ER in this population is not recommended.
Use NUCYNTA® ER with caution in patients with moderate hepatic impairment. Initiate treatment in these patients using 50 mg NUCYNTA® ER and administer no more frequently than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER once daily [see Clinical Pharmacology (12.3)].
No dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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.