From the Guidelines
Nucynta (tapentadol) should be dosed at 50 to 100 mg orally every 4 hours as needed, with a maximal daily dose of 500 mg per day for the ER formulation or 600 mg per day for the IR formulation. When determining the dosing for Nucynta, it is essential to consider the patient's pain severity, hepatic and renal function, and other individual characteristics. According to the NCCN clinical practice guidelines in oncology 1, tapentadol is available as ER and IR formulations and is used for treatment of moderate to severe pain as well as for neuropathic pain. Some key points to consider when dosing Nucynta include:
- Typical doses start at 50 to 100 mg orally every 4 hours as needed
- Maximal daily dose of 500 mg per day for the ER formulation or 600 mg per day for the IR formulation
- Lower doses are recommended for patients with moderate hepatic impairment
- Tapentadol should be avoided in patients with severe hepatic or renal impairment It is crucial to individualize dosing, starting at the lower end of the range for elderly patients, those with renal or hepatic impairment, or opioid-naive individuals, and to monitor patients regularly during treatment to minimize the risk of adverse effects, such as respiratory depression, sedation, physical dependence, and other opioid-related adverse effects, as noted in the guidelines 1.
From the FDA Drug Label
2 DOSAGE AND ADMINISTRATION
- 1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse
- 2 Initial Dosage Initiating Treatment with NUCYNTA Tablets Initiate treatment with NUCYNTA tablets in a dosing range of 50 mg to 100 mg every 4 to 6 hours as needed for pain.
The dosing for Nucynta (tapentadol) is:
- Initial dose: 50 mg to 100 mg every 4 to 6 hours as needed for pain
- Subsequent doses: 50 mg, 75 mg, or 100 mg every 4 to 6 hours, adjusted to maintain adequate analgesia with acceptable tolerability
- Maximum daily dose: Not more than 700 mg on the first day and 600 mg on subsequent days
- Conversion from NUCYNTA tablets to NUCYNTA ER: Use the equivalent total daily dose of NUCYNTA tablets and divide it into two equal doses of NUCYNTA ER separated by approximately 12-hour intervals
- Dosage modifications in patients with hepatic impairment:
- Moderate hepatic impairment: Initiate treatment with 50 mg no more frequently than once every 8 hours (maximum of three doses in 24 hours)
- Mild hepatic impairment: No dosage adjustment is recommended
- Severe hepatic impairment: Use is not recommended 2
From the Research
Dosing Information for Nucynta (Tapentadol)
- The dosing for Nucynta (tapentadol) is as follows:
- Tapentadol IR can be taken every 4 to 6 hours as needed for pain, with a maximum total daily dose (TDD) of 500 mg 4
- Tapentadol ER allows for twice daily dosing 3
- The median TDD administered in a study was 300.0 mg for both tapentadol IR and tapentadol ER 4
Conversion Between Tapentadol IR and ER
- Approximately equivalent TDDs of tapentadol IR and tapentadol ER provided equivalent analgesic efficacy for the relief of moderate to severe chronic low back pain and were similarly well tolerated, allowing for direct conversion between the 2 formulations 4
Comparison with Other Medications
- Tapentadol IR had comparable analgesic efficacy and overall safety to that of oxycodone IR for the relief of moderate to severe, acute low back pain and associated radicular leg pain when using flexible dosing regimens 5
- Tapentadol IR demonstrated a better gastrointestinal tolerability profile, particularly for the common opioid-related adverse events of vomiting and constipation, compared to oxycodone IR 5