Indications for: NUCYNTA
Acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Use only if alternative treatment options (eg, non-opioid analgesics, opioid combination products) are ineffective, not tolerated, or otherwise inadequate to provide sufficient analgesia.
Orthopedic Surgery – Bunionectomy
The efficacy and safety of Nucynta was evaluated in a randomized, double-blind, parallel-group, active- and placebo-controlled, multiple-dose study in patients 18 to 80 years of age who were experiencing moderate to severe pain after unilateral, first metatarsal bunionectomy surgery. Patients received placebo or Nucynta 50mg, 75mg, and 100mg every 4 to 6 hours for 72 hours.
At each dose, Nucynta achieved a greater reduction in pain based on SPID48 values compared with placebo. A greater proportion of patients achieved a reduction in pain intensity at 48 hours of 30% or greater, or 50% or greater were significantly higher in patients treated with Nucynta tablets at each dose vs placebo.
End-Stage Degenerative Joint Disease
The efficacy and safety of Nucynta was evaluated in a randomized, double-blind, parallel-group, active- and placebo-controlled, multiple-dose study in patients 18 to 80 years of age who were experiencing moderate to severe pain from end stage degenerative joint disease of the hip or knee. Patients received placebo or Nucynta 50mg and 75mg every 4 to 6 hours during waking hours for 10 days.
At each dose, Nucynta achieved improvement in pain based on the 5-day SPID vs placebo. A greater proportion of patients achieved a reduction in pain intensity at 5 days of 30% or greater, or 50% or greater were significantly higher in patients treated with Nucynta tablets at each dose vs placebo.
Use lowest effective dose for shortest duration. ≥18yrs: initially 50–100mg every 4–6 hrs as needed. First day of dosing: may give second dose one hour after first dose if pain relief is inadequate; subsequent doses should be given every 4–6 hrs. Max 700mg/day on the first day, 600mg/day on subsequent days. Moderate hepatic impairment: initially 50mg every 8 hours; max 3 doses/24 hours. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
<6yrs (<40kg): not recommended. Use lowest effective dose for shortest duration. Swallow whole. ≥6yrs (40–59kg): 50mg (max per single dose) every 4hrs, if inadequate, use oral soln; (60–79kg): initially 50mg every 4hrs, may increase to max 75mg per single dose every 4hrs; (≥80kg): initially 50mg every 4hrs, may increase to 75mg every 4hrs or if needed, up to max 100mg per single dose every 4hrs. Max 7.5mg/kg/day. Treatment duration: max 3 days. Hepatic or renal impairment, daily doses >600mg (or >100mg per dose): not recommended.
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.
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.
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. Hepatic or renal impairment in children: not recommended. Severe renal or hepatic impairment in adults: not recommended. Consider reducing current opioid analgesic dose or rotating opioid if opioid-induced hyperalgesia is suspected. 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.
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.
Nausea, constipation, dizziness, vomiting, headache, somnolence; respiratory depression, severe hypotension, syncope, opioid-induced hyperalgesia. Also in children: pruritus, pyrexia.
Renal (99%). Half-life: 4 hours. Clearance: 1530 +/- 177 mL/min.
Generic Drug Availability:
Tabs—100; ER tabs—60