Dosing and Administration

NUCYNTA® ER Dosing and Administration

NUCYNTA® ER is available in 50-mg, 100-mg, 150-mg, 200-mg, and 250-mg tablets


NUCYNTA® ER maintenance dose range of 100 mg to 250 mg twice daily
  • NUCYNTA® ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
  • The maintenance dose is 100 mg to 250 mg twice daily, taken approximately every 12 hours.
  • Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every 3 days.
  • Maximum 24-hour dose is 500 mg. Do not exceed a total daily dose of 500 mg
  • Dosing regimen for NUCYNTA® ER may be individualized according to: patient’s prior analgesic treatment experience; general condition and medical status; concurrent medications; and risk factors for addiction, abuse, and misuse.
  • Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions as well as monitor for the development of addiction, abuse, or misuse.
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NUCYNTA® ER may be administered with or without food.

*Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day or an equianalgesic dose of another opioid.

 

Learn about the dosing and titration of NUCYNTA® ER


 

NUCYNTA® ER (tapentadol) is indicated for the management of:

  • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Usage

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA® ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

  • NUCYNTA® ER is not indicated as an as-needed (prn) analgesic.

NUCYNTA® ER IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL

Addiction, Abuse, and Misuse: NUCYNTA® ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing NUCYNTA® ER, and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTA® ER. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole; crushing, chewing, or dissolving NUCYNTA® ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol.

Accidental Ingestion: Accidental ingestion of even one dose of NUCYNTA® ER, especially by children, can result in a fatal overdose of tapentadol.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Interaction With Alcohol: Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking NUCYNTA® ER. The co-ingestion of alcohol with NUCYNTA® ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol.

  • After abrupt discontinuation or a significant dose reduction of NUCYNTA® ER in physically dependent patients. When discontinuing NUCYNTA® ER, gradually taper the dose.
  • If mixed agonist/antagonist (e.g., butorphanol, nalbuphine, pentazocine) and partial agonist (e.g., buprenorphine) analgesics are used in patients who have received or are receiving NUCYNTA® ER. Avoid use with mixed agonists/antagonists and partial agonists.
  • If opioid antagonists (e.g., naloxone, nalmefene) are administered in physically dependent patients. Administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

 

NUCYNTA® (tapentadol) is indicated for the management of moderate to severe acute pain in adults.

NUCYNTA® IMPORTANT SAFETY INFORMATION

Contraindications: Significant respiratory depression; acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity to tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.

  • After abrupt discontinuation or a significant dose reduction of NUCYNTA® in physically dependent patients. When discontinuing NUCYNTA®, gradually taper the dose.
  • If mixed agonists/antagonists (e.g., butorphanol, nalbuphine, pentazocine) and partial agonists (e.g., buprenorphine) are used in patients who have received or are receiving NUCYNTA®. Avoid the use of mixed agonists/antagonists and partial agonists with NUCYNTA®.
  • If opioid antagonists (e.g., naloxone, nalmefene) are administered in physically dependent patients. Administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
  • Renal: Use of NUCYNTA® in patients with severe renal impairment (CLCR <30 mL/min) is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.
  • Hepatic: Avoid use of NUCYNTA® in patients with severe hepatic impairment (Child-Pugh Score 10-15); reduce the dose in patients with moderate impairment (Child-Pugh Score 7-9).

Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients in the lower range of recommended doses.

 

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Please see full Prescribing Information for NUCYNTA®.