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NUCYNTA ER
Narcotic analgesics
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Drug Name:

NUCYNTA ER CII

Generic Name and Formulations:
Tapentadol 50mg, 100mg, 150mg, 200mg, 250mg; ext-rel tabs.

Company:
Depomed, Inc.

Therapeutic Use:

Indications for NUCYNTA ER:

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 opioid therapies 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.

Adult:

Individualize. Swallow whole. Monitor for respiratory depression within the first 72hrs. ≥18yrs: Usual dose: 100–250mg twice daily (approx. every 12hrs). Opioid-naïve: initially 50mg twice daily (approx. every 12hrs); 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 12hr intervals. Nucynta ER doses >500mg daily: not recommended. Converting from oxycodone CR and other opioids to Nucynta ER: see full labeling. Moderate hepatic impairment: initially 50mg once every 24hrs; max 100mg once daily.

Children:

<18yrs: not established.

Contraindications:

Significant respiratory depression. Acute or severe bronchial asthma or hypercarbia (in unmonitored settings or in the absence of resuscitative equipment). Known or suspected paralytic ileus. During or within 14 days of MAOIs.

Warnings/Precautions:

Increased risk of fatal respiratory depression (esp. when initiating therapy and during dose increases); monitor. Abuse potential (monitor routinely). Accidental exposure may result in fatal overdose (esp. children). Risk of neonatal opioid withdrawal syndrome. Pulmonary disease (eg, COPD, cor pulmonale); monitor for respiratory depression (esp. within the first 24–72hrs of initiating therapy and after dose increases); consider alternative non-opioid analgesic. Head injury. Impaired consciousness, coma, shock; avoid. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. GI obstruction. Biliary tract disease. Acute pancreatitis. Drug abusers; monitor. Avoid abrupt cessation. Severe renal or hepatic impairment: not recommended. Moderate hepatic impairment. Elderly. Debilitated. Cachectic. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant alcohol or alcohol-containing medications; may cause fatal overdose. Avoid mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Increased risk of respiratory depression with concomitant CNS depressants (eg, sedatives, hypnotics, anxiolytics, neuroleptics, tranquilizers, anesthetics, phenothiazines, other opioids, alcohol); consider reducing dose for one or both drugs. Potentiates muscle relaxants; monitor. Serotonin syndrome possible with concomitant SSRIs, SNRIs, tricyclics, MAOIs, triptans, other drugs that impair metabolism of serotonin. Increased risk of urinary retention and/or severe constipation with anticholinergics.

Pharmacological Class:

Opioid.

Adverse Reactions:

Nausea, constipation, headache, dizziness, somnolence; respiratory or CNS depression, hypotension (monitor), neonatal opioid withdrawal syndrome.

Metabolism:

Hepatic (CYP2C9, 2C19, 2D6).

Elimination:

Renal.

REMS:

YES

Generic Availability:

NO

How Supplied:

Tabs—60

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