NUCYNTA ER CII

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.

Adult Dose for NUCYNTA ER:

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.

Children's Dose for NUCYNTA ER:

<18yrs: not recommended (accidental ingestion may result in fatal overdose).

Pharmacological Class:

Opioid.

Contraindications:

Significant respiratory depression, severe asthma or hypercapnia (in unmonitored settings or in the absence of resuscitative equipment). Paralytic ileus. During or within 14 days of MAOIs.

Warnings/Precautions:

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.

Interactions:

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.

Adverse Reactions:

Nausea, constipation, headache, dizziness, somnolence; respiratory, CNS depression, hypotension.

Metabolism:

Hepatic (CYP2C9, 2C19, 2D6).

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

ER tabs—60