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Nucynta Er Generic Name & Formulations
Legal Class
CII
General Description
Tapentadol 50mg, 100mg, 150mg, 200mg, 250mg; ext-rel tabs.
Pharmacological Class
Opioid agonist.
See Also
How Supplied
Tabs—100; ER tabs—60
Manufacturer
Generic Availability
NO
Nucynta Er Indications
Indications
Management of pain or neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term analgesia for which alternative treatment options are inadequate.
Limitations of Use
Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Nucynta Er Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Swallow whole. ≥18yrs: Individualize. Usual dose: 100–250mg twice daily (approx. every 12hrs). Opioid-naïve or opioid non-tolerant: initially 50mg twice daily (approx. every 12hrs); titrate to optimal dose. Max 500mg/day. Converting from Nucynta to Nucynta ER: divide total daily dose of Nucynta into two equal doses of Nucynta ER separated by 12hr intervals. Converting from other opioids: see full labeling. Moderate hepatic impairment: initially 50mg once every 24hrs; max 100mg/day. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
Children
<18yrs: not established.
Nucynta Er Contraindications
Contraindications
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.
Nucynta Er Boxed Warnings
Boxed Warning
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
Nucynta Er Warnings/Precautions
Warnings/Precautions
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Severe renal or hepatic impairment: not recommended. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants if used; for ER tabs: not recommended.
REMS
Nucynta Er Pharmacokinetics
See Literature
Nucynta Er Interactions
Interactions
See Contraindications. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Nucynta Er Adverse Reactions
Adverse Reactions
Nausea, constipation, dizziness, vomiting, headache, somnolence; respiratory depression, severe hypotension, syncope.
Nucynta Er Clinical Trials
See Literature
Nucynta Er Note
Not Applicable
Nucynta Er Patient Counseling
See Literature
