Nucynta ER (Tapentadol)


Nucynta ER (Tapentadol)


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What is Nucynta ER (Tapentadol)?

NUCYNTA ER (tapentadol) is a mu-opioid receptor agonist, supplied in extendedrelease film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride.

Indications for Nucynta ER (Tapentadol)

Nucynta ER (Tapentadol) is used to manage pain or neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term analgesia for which alternative treatment options are inadequate.

Nucynta ER (Tapentadol) ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing NUCYNTA ER, and monitor all patients regularly for the development of these behaviors and conditions.


The following serious adverse reactions are discussed elsewhere in the labeling:

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.


Use lowest effective dose for shortest duration. Swallow whole. ≥18yrs: Individualize. Usual dose: 100–250mg twice daily (approx. every 12hrs). Opioid-naïve or opioid non-tolerant: initially 50mg twice daily (approx. every 12hrs); titrate to optimal dose. Max 500mg/day. Converting from Nucynta to Nucynta ER: divide total daily dose of Nucynta into two equal doses of Nucynta ER separated by 12hr intervals. Converting from other opioids: see full labeling. Moderate hepatic impairment: initially 50mg once every 24hrs; max 100mg/day. Withdraw gradually by 25–50% every 2–4 days.


<18yrs: not established.

Boxed Warning:

Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.

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