"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® ER (tapentadol) is indicated for the management of:
- moderate to severe chronic pain in adults
- neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults
when a continuous, around-the-clock opioid analgesic is needed for an extended period of time [see Clinical Studies].
Limitations of Usage
NUCYNTA® ER is not intended for use:
- As an as-needed (prn) analgesic
- For pain that is mild or not expected to persist for an extended period of time
- For acute pain
- For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
DOSAGE AND ADMINISTRATION
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 72 hours of initiating therapy with NUCYNTA® ER [see WARNINGS AND PRECAUTIONS].
Consider the following factors when selecting an initial dose of NUCYNTA® ER:
- Total daily dose, potency, and kind of any prior analgesic the patient has been taking previously;
- Reliability of the relative potency estimate used to calculate the equivalent dose of tapentadol needed (Note: potency estimates may vary with the route of administration);
- Patient's degree of opioid experience and opioid tolerance;
- General condition and medical status of the patient;
- Concurrent medication;
- Type and severity of the patient's pain.
NUCYNTA® ER is administered at a frequency of twice daily (every 12 hours).
Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see Serotonin Syndrome Risk]. 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.
Use of NUCYNTA® ER as the First Opioid Analgesic
Initiate NUCYNTA® ER therapy with the 50 mg tablet twice daily (at 12 hour intervals).
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.
Conversion from other Opioids to NUCYNTA® ER
While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. As such, it is safer to underestimate a patient's 24-hour NUCYNTA® ER requirement and provide rescue medication (e.g., immediate-release opioid or non-opioid) than to overestimate and manage an adverse reaction. In general, begin with half of the estimated daily tapentadol requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release rescue medication.
Published relative potency/equianalgesia data are available and may be referred to in clinical practice guidelines such as those published by authorities in the field of pain medicine, but such ratios are approximations. Consider contacting your specific state medical or pharmacy professional societies for further information on how to safely convert patients from one opioid to another.
Titration and Maintenance of Therapy
Individually titrate NUCYNTA® ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for noncancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three days. In clinical studies, efficacy with NUCYNTA® ER was demonstrated relative to placebo in the dosage range of 100 mg to 250 mg twice daily [see Clinical Studies].
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the NUCYNTA® ER dose to decrease the level of pain.
Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid or non-opioid medication.
If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.
Discontinuation of NUCYNTA® ER
When the patient no longer requires therapy with NUCYNTA® ER tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.
Patients with Hepatic Impairment
The use of NUCYNTA® ER in patients with severe hepatic impairment (Child-Pugh Score 10-15) is not recommended.
In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), initiate treatment 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].
Patients with Renal Impairment
No dosage adjustment is recommended in patients with mild or moderate renal impairment. NUCYNTA® ER use in patients with severe renal impairment is not recommended [see WARNINGS AND PRECAUTIONS and 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 [see CLINICAL PHARMACOLOGY].
Administration of NUCYNTA® ER
Instruct patients to swallow NUCYNTA® ER tablets whole. The tablets are not to be cut, crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of tapentadol [see WARNINGS AND PRECAUTIONS].
Instruct patients to take NUCYNTA® ER one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see WARNINGS AND PRECAUTIONS, and PATIENT INFORMATION].
Dosage Forms And Strengths
NUCYNTA® ER 50 mg, 100 mg, 150 mg, 200 mg and 250 mg extended-release tablets are available in the following colors and prints:
- 50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side
- 100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side
- 150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side
- 200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and a black print “OMJ 200” on one side
- 250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and a white print “OMJ 250” on one side.
NUCYNTA® ER tablets are available in the following strengths and packages:
50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-860-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-860-02).
100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side and are available in bottles of 60 with child-resistant closure (NDC 50458-861-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-861-02).
150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side and are available in bottles of 60 with childresistant closure (NDC 50458-862-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-862-02).
200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print “OMJ 200” on one side, and are available in bottles of 60 with child-resistant closure (NDC 50458-863-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-863-02).
250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print “OMJ 250” on one side, and are available in bottles of 60 with child-resistant closure (NDC 50458-864-01) and unit dose blister packs of 100 (10 blister strips of 10 tablets each), for hospital use only (NDC 50458-864-02).
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® ER in a secure place out of reach of children.
NUCYNTA® ER 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: August 2012
Last reviewed on RxList: 10/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta ER 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.
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