NUCYNTA ER CII
Generic Name and Formulations:
Tapentadol 50mg, 100mg, 150mg, 200mg, 250mg; ext-rel tabs.
Janssen Pharmaceuticals, Inc.
Indications for NUCYNTA ER:
For use when a continuous, around-the-clock opioid analgesic is needed for an extended period of time to treat: 1) moderate to severe chronic pain; 2) neuropathic pain associated with diabetic peripheral neuropathy (DPN). Not for as-needed use.
Individualize. Swallow whole; do not break, chew, dissolve or crush tabs. Monitor for respiratory depression within the first 72hrs. ≥18yrs: Usual dose: 100–250mg twice daily (approx. every 12 hours). Opioid-naïve: initially 50mg twice daily (approx. every 12 hours); then titrate to optimal dose within therapeutic range of 100–250mg twice daily. Converting from Nucynta to Nucynta ER: divide total daily dose of Nucynta into two equal doses of Nucynta ER separated by 12 hour intervals. Nucynta ER doses >500mg: not recommended. Converting from oxycodone CR and other opioids to Nucynta ER: see literature. Moderate hepatic impairment: initially 50mg once every 24 hours; max 100mg once daily.
<18yrs: not recommended (accidental ingestion may result in fatal overdose).
Significant respiratory depression, severe asthma or hypercarbia (in unmonitored settings or in the absence of resuscitative equipment). Paralytic ileus. During or within 14 days of MAOIs.
Not for management of acute or post-op pain. Severe renal or hepatic impairment: not recommended. Moderate hepatic impairment. COPD, cor pulmonale: consider alternative non-opioid analgesics. CNS depression. Coma. Head injury. Increased intracranial pressure. Hypovolemia. Circulatory shock; avoid. Seizure disorders. GI or GU obstruction. Paralytic ileus. Biliary tract disease. Acute pancreatitis. Drug abusers; monitor. Avoid abrupt cessation. Elderly. Debilitated. Cachectic. Pregnancy (Cat.C). Monitor neonates, whose mothers have been taking Nucynta ER, for respiratory depression. Labor & delivery, nursing mothers: not recommended.
See Contraindications. Avoid concomitant alcohol or alcohol-containing medications; may cause fatal overdose. Additive CNS depression, hypotension with other CNS depressants (eg, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, alcohol); consider reducing dose. Serotonin syndrome possible with concomitant SSRIs, SNRIs, tricyclics, MAOIs, triptans, other drugs that impair metabolism of serotonin. Concomitant mixed agonists/antagonists, (butorphanol, nalbuphine, pentazocine), partial agonists (eg, buprenorphine), and anticholinergics: not recommended.
Nausea, constipation, headache, dizziness, somnolence; respiratory or CNS depression, hypotension (monitor).
Hepatic (CYP2C9, 2C19, 2D6).