Generic Name and Formulations:
Tapentadol 50mg, 75mg, 100mg tabs.
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.
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 by 25–50% every 2–4 days.
<18yrs: not established.
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.
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). 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.
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. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, 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 precipitate withdrawal symptoms. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Nausea, constipation, dizziness, vomiting, headache, somnolence; respiratory depression, severe hypotension, syncope.
Hepatic (CYP2C9, 2C19, 2D6).
Tabs—100; ER tabs—60
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