Nucynta ER 250 mg/1
tapentadol hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Collegium Pharmaceutical, Inc.
Nucynta ER is a tablet, film coated, extended release containing tapentadol hydrochloride at 250 mg/1, taken oral. Manufactured by Collegium Pharmaceutical, Inc..
Key Facts
- Brand Name
- Nucynta ER
- Generic Name
- tapentadol hydrochloride
- NDC Code (Product)
24510-291- Manufacturer
- Collegium Pharmaceutical, Inc.
- Strength
- 250 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA200533
- Marketing Start
- 04/19/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including NUCYNTA ER, for…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION NUCYNTA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of NUCYNTA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks ( 2.1 ). Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment, and response, and risk factors for addiction, abuse, and misuse. ( 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with NUCYNTA ER. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with NUCYNTA ER, e…
Contraindications
4 CONTRAINDICATIONS NUCYNTA ER is contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Hypersensitivity (e.g., anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product [see Adverse Reactions (6.2) ] . Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Drug Interactions (7) ]. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma ( 4 ) Known or suspected paralytic ileus ( 4 ) Hypersensitivity to tapentadol or to any other ingredients of the product ( 4 ) Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with NUCYNTA ER. Table 3. Clinically Significant Drug Interactions with NUCYNTA ER Alcohol Clinical Impact: Concomitant use of alcohol with NUCYNTA ER can result in an increase of tapentadol plasma levels and potentially fatal overdose of tapentadol. Intervention: Instruct patients not to consume alcoholic beverages or use prescription or non- prescription products containing alcohol while on NUCYNTA ER therapy [see Warnings and Precautions (5.3) ] . Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3) ] . Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (incl…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interaction with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] The most common (≥10%) adverse reactions were nausea, constipation, dizziness, headache, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-855-331-5615 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under w…
Frequently Asked Questions
What is Nucynta ER used for?
Nucynta ER contains tapentadol hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Nucynta ER a controlled substance?
Yes, Nucynta ER is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Nucynta ER?
The generic name for Nucynta ER is tapentadol hydrochloride. There are 9 other brand versions of tapentadol hydrochloride.
What is the NDC code for Nucynta ER 250 mg/1?
The NDC (National Drug Code) for Nucynta ER 250 mg/1 is 24510-291, listed by Collegium Pharmaceutical, Inc..