tapentadol hydrochloride
tapentadol hydrochloride is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Nucynta ER, Nucynta. Available dosage forms: tablet, film coated, extended release, tablet, film coated.
Drug Details
- Generic Name
- tapentadol hydrochloride
- Brand Names
- Nucynta ER, Nucynta
- Application Number
- NDA200533
- Sponsor
- Collegium Pharmaceutical, Inc.
- NDC Codes
- 8
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- TAPENTADOL HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1) ] , reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Tapentadol tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Tapentadol tablets are an opioid analgesic indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1 ), reserve tapentadol tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Tapentadol tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.