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NUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS … 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS … 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require HIGHLIGHTS OF PRESCRIBING INFORMATION • DISCUSS 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION • DISCUSS 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION • DISCUSS 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CIISEE MORE ONNUCYNTA.COM
NUCYNTA® (TAPENTADOL) TABLETS, CII NUCYNTA ® (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. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) IMMEDIATE-RELEASE TABLETS, CII NUCYNTA ® (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.. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (eg, non NUCYNTA® (TAPENTADOL) INDICATIONS AND USAGE WARNING Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if MAKING THE MOST OF YOUR TREATMENT 6 POSSIBLE SIDE EFFECTS NUCYNTA and NUCYNTA ER can cause the following: – dizzinessconstipation – nausea – headachesleepiness – vomiting – tiredness – abdominal pain Call your healthcare provider if you have any of these symptoms and they are severe. MEDICATION GUIDE NUCYNTA (NEW-SINN-TAH) OR HERBAL Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
HIGHLIGHTS OF PRESCRIBING INFORMATION 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION ORALLY TWICE DAILYNUCYNTA ER COUPONNUCYNTA ER DOSESNUCYNTA ER MORPHINE EQUIVALENT DOSENUCYNTA ER VSOXYCODONE
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 NUCYNTA (NEW-SINN-TAH) (TAPENTADOL) TABLETS, CII NUCYNTA 11 Medication Guide NUCYNTA (new-SINN-tah) (tapentadol) tablets, CII NUCYNTA tablets are: • A strong prescription pain medicine thatcontains an opioid
NUCYNTA ER (TAPENTADOL) INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: • Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® TABLETS safely andeffectively.
NUCYNTA® ER (TAPENTADOL) EXTENDED-RELEASE TABLETS, CII NUCYNTA® ER (tapentadol) extended-release tablets, CII HIGHLIGHTS OF PRESCRIBING INFORMATION • DISCUSS 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® ER safely and effectively. See full prescribing information for NUCYNTA® ER NUCYNTA® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008 MEDICATION GUIDE NUCYNTA ER (NEW-SINN-TAH E-R) (TAPENTADOL 13 Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended- release oral tablets, CII NUCYNTA ER is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require NUCYNTA® ER (tapentadol) extended-release tablets, CII & NUCYNTA® (tapentadol) tablets, CII | Patient Homepage* Menu
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INDICATIONS AND USAGE NUCYNTA ER (tapentadol) is indicated for the management of: * Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options areinadequate
* Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options areinadequate
NUCYNTA ER (tapentadol) is indicated for the management of: * Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options areinadequate
* Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options areinadequate
Limitations of Use
* Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate‑release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. * NUCYNTA ER is not indicated as an as-needed (prn) analgesic. IMPORTANT SAFETY INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNSDEPRESSANTS
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHERCNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE NUCYNTAÂ 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 NUCYNTAÂ ER, and monitor all patients regularly for the development of these behaviorsand conditions.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)PROGRAM
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS‑compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: * complete a REMS‑compliant education program, * counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, * emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by theirpharmacist, and
* consider other tools to improve patient, household, and communitysafety.
LIFE-THREATENING RESPIRATORY DEPRESSION Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTAÂ ER. Monitor for respiratory depression, especially during initiation of NUCYNTAÂ ER or following a dose increase. Instruct patients to swallow NUCYNTAÂ ER tablets whole; crushing, chewing, or dissolving NUCYNTAÂ ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol. ACCIDENTAL INGESTION Accidental ingestion of even one dose of NUCYNTAÂ ER, especially by children, can result in a fatal overdose of tapentadol. NEONATAL OPIOID WITHDRAWAL SYNDROME Prolonged use of NUCYNTAÂ ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. INTERACTION WITH ALCOHOL Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking NUCYNTAÂ ER. The co-ingestion of alcohol with NUCYNTAÂ ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNSDEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. * Reserve concomitant prescribing of NUCYNTAÂ ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. * Limit dosages and durations to the minimum required. * Follow patients for signs and symptoms of respiratory depressionand sedation.
CONTRAINDICATIONS:
NUCYNTAÂ 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, includingparalytic ileus
* Hypersensitivity (e.g. anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product * Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days WARNINGS AND PRECAUTIONS: ADDICTION, ABUSE, AND MISUSE NUCYNTAÂ ER contains tapentadol, a Schedule II controlled substance. As an opioid, NUCYNTAÂ ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as NUCYNTAÂ ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount oftapentadol present.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTAÂ ER. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing NUCYNTAÂ ER, and monitor all patients receiving NUCYNTAÂ ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of NUCYNTAÂ ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as NUCYNTAÂ ER, but use in such patients necessitates intensive counseling about the risks and proper use of NUCYNTAÂ ER along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of NUCYNTAÂ ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of tapentadol and can result in overdose and death. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing NUCYNTAÂ ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact the local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: * Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support ofPatients with Pain.
* Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG.
* Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. * Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1‑800‑503‑0784, or log on to www.opioidanalgesicrems.com . The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.
LIFE-THREATENING RESPIRATORY DEPRESSION Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of NUCYNTAÂ ER, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression especially within the first 24-72 hours of initiating therapy with and following dosage increases of NUCYNTAÂ ER. To reduce the risk of respiratory depression, proper dosing and titration of NUCYNTAÂ ER are essential. Overestimating the NUCYNTAÂ ER dosage when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental ingestion of even one dose of NUCYNTAÂ ER, especially by children, can result in respiratory depression and death due to an overdose of tapentadol. NEONATAL OPIOID WITHDRAWAL SYNDROME Prolonged use of NUCYNTAÂ ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNSDEPRESSANTS
Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on NUCYNTAÂ ER therapy. The co-ingestion of alcohol with NUCYNTAÂ ER may result in increased plasma tapentadol levels and a potentially fatal overdose oftapentadol.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of NUCYNTAÂ ER with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs withopioid analgesics.
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when NUCYNTAÂ ER is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressants have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs. RISK OF LIFE-THREATENING RESPIRATORY DEPRESSION IN PATIENTS WITH CHRONIC PULMONARY DISEASE OR IN ELDERLY, CACHECTIC, OR DEBILITATEDPATIENTS
The use of NUCYNTAÂ ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. _PATIENTS WITH CHRONIC PULMONARY DISEASE:_ NUCYNTAÂ ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of NUCYNTAÂ ER. _ELDERLY, CACHECTIC, OR DEBILITATED PATIENTS_: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Alternatively, consider the use of non-opioid analgesics in thesepatients.
Monitor such patients closely, particularly when initiating and titrating NUCYNTA ER and when NUCYNTA ER is given concomitantly with other drugs that depress respiration. SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of tapentadol with serotonergic drugs. Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5‑HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including MAO inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). This may occur within the recommended dosage range. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue NUCYNTA ER if serotonin syndrome is suspected. ADRENAL INSUFFICIENCY Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non‑specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenalinsufficiency.
SEVERE HYPOTENSION
NUCYNTAÂ ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of NUCYNTAÂ ER. In patients with circulatory shock, NUCYNTAÂ ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of NUCYNTAÂ ER in patients with circulatory shock. RISKS OF USE IN PATIENTS WITH INCREASED INTRACRANIAL PRESSURE, BRAIN TUMORS, HEAD INJURY, OR IMPAIRED CONSCIOUSNESS In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), NUCYNTAÂ ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with NUCYNTAÂ ER. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of NUCYNTAÂ ER in patients with impaired consciousness or coma. RISKS OF USE IN PATIENTS WITH GASTROINTESTINAL CONDITIONS NUCYNTAÂ ER is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The tapentadol in NUCYNTAÂ ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, forworsening symptoms.
INCREASED RISK OF SEIZURES IN PATIENTS WITH SEIZURE DISORDERS The tapentadol in NUCYNTAÂ ER may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during NUCYNTAÂ ER therapy.WITHDRAWAL
Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including NUCYNTAÂ ER. In these patients, mixed agonists/antagonists and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. When discontinuing NUCYNTAÂ ER, gradually taper the dose. Do not abruptly discontinue NUCYNTAÂ ER. RISKS OF DRIVING AND OPERATING MACHINERY NUCYNTAÂ ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of NUCYNTAÂ ER and know how they will react to the medication. RISK OF TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT A study with an immediate-release formulation of tapentadol in subjects with hepatic impairment showed higher serum concentrations of tapentadol than in those with normal hepatic function. Avoid use of NUCYNTAÂ ER in patients with severe hepatic impairment. Reduce the dose of NUCYNTAÂ ER in patients with moderate hepatic impairment. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression when initiating and titrating NUCYNTAÂ ER. RISK OF TOXICITY IN PATIENTS WITH RENAL IMPAIRMENT Use of NUCYNTAÂ ER in patients with severe renal impairment is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.ADVERSE REACTIONS:
In clinical studies, the most common (≤10%) adverse reactions were nausea, constipation, dizziness, headache, and somnolence. PLEASE SEE FULL PRESCRIBING INFORMATION FOR MORE INFORMATIONABOUT NUCYNTA ER.
* Access and Support* Co‑pay Card
* Patient Site
-->
SAVE WITH THE
NUCYNTA® ER (TAPENTADOL)/ NUCYNTA® (TAPENTADOL)SAVINGS CARD
Eligible patients pay as little as $35* for each prescription of* NUCYNTAÂ ER
* NUCYNTA
DOWNLOAD AND PRINT A SAVINGS CARD *Offer valid for commercially insured patients only. Maximum savings limit applies; patient out‑of‑pocket expense may vary. Please see Program Terms, Conditions, and Eligibility Criteria, below.HOW YOU CAN SAVE:
* Present your Co-pay Card to your pharmacist along with your NUCYNTA ER or NUCYNTA prescription to receive instant savings * Most eligible commercially insured patients will pay as little as $35 (maximum benefit amount of $100) for NUCYNTA ER or NUCYNTAtablets
* If you have questions about the NUCYNTA ER or NUCYNTA savings offer please call 1‑844‑807‑0348 For Indications and Usage and Important Safety Information for NUCYNTA ER, click here. Please see full Prescribing Information , including Boxed Warning and Medication Guide, for more informationabout NUCYNTA ER.
------------------------- PROGRAM TERMS, CONDITIONS, AND ELIGIBILITY Offer is valid for commercially insured patients only. Most eligible commercially insured patients will pay as little as $35 (maximum benefit amount of $100) for Nucynta ER or Nucynta tablets. Any remaining out-of-pocket expense will be the patient's responsibility. This offer is valid in the United States. Some restrictions may apply. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, Tricare or other federal or state health programs (such as medical assistance programs). Cash Discount Cards and other non-insurance plans are not valid as primary under this offer. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she will comply with any terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. This offer is not valid for cash paying patients. Offer not valid for patients under 18 years of age. PROGRAM NOT VALID IN MASSACHUSETTS OR IN ANY OTHER STATE OR JURISDICTION WHERE PROHIBITED OR RESTRICTED BY LAW. PATIENT INSTRUCTIONS: To redeem this offer, you must have a valid prescription for Nucynta ER or Nucynta and follow the dosage instructions provided by your healthcare provider with a valid Prescriber ID# (e.g. NPI or DEA). This offer may not be redeemed for cash. Patients with questions about the Nucynta ER or Nucynta savings offer should call 1‑844‑807‑0348. PHARMACIST: When you apply this offer, you are certifying that you have not submitted a claim for reimbursement under any federal, state, or other governmental programs for this prescription. Participation in this program must comply with all applicable laws and regulations as apharmacy provider.
PHARMACIST INSTRUCTIONS FOR A PATIENT WITH AN ELIGIBLE THIRD PARTY PAYER: Submit the claim to the primary Third Party Payer first, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code (E.G. 8). Most eligible commercially insured patients will pay as little as $35 (maximum benefit amount of $100) for Nucynta® ER or Nucynta® tablets. Reimbursement will be received from CHANGE HEALTHCARE. Valid Other Coverage Code required. For any questions regarding CHANGE HEALTHCARE online processing, please call the Help Desk at 1‑800‑433‑4893. PROGRAM EXPIRES 06/30/2020. This offer is not transferable and is limited to one offer per person. Not valid if reproduced. Void where prohibited by law. Program managed by ConnectiveRx on behalf of Collegium Pharmaceutical. The parties reserve the right to rescind, revoke or amend this offer withoutnotice at any time.
INDICATIONS AND USAGE NUCYNTA® ER (TAPENTADOL) IS:*
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannottolerate them
*
Also used to manage pain from damaged nerves (neuropathic pain) that happens with diabetes and is severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines, do not treat your pain well enough or you cannot tolerate them*
A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death*
Not used to treat pain that is not around-the-clock pain IMPORTANT INFORMATION ABOUT NUCYNTAÂ ER:*
GET EMERGENCY HELP RIGHT AWAY IF YOU TAKE TOO MUCH NUCYNTAÂ ER (OVERDOSE). When you first start taking NUCYNTAÂ ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur*
Taking NUCYNTAÂ ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death*
Never give anyone your NUCYNTAÂ ER. They could die from taking it. Selling or giving away NUCYNTAÂ ER tablets is against the law*
Store NUCYNTAÂ ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home DO NOT TAKE NUCYNTA ER IF YOU HAVE:*
severe asthma, trouble breathing, or other lung problems*
a bowel blockage or have narrowing of the stomach or intestines BEFORE TAKING NUCYNTAÂ ER, TELL YOUR HEALTHCARE PROVIDER IF YOU HAVE AHISTORY OF:
*
head injury, seizures*
problems urinating
*
abuse of street or prescription drugs, alcohol addiction, or mentalhealth problems
*
liver, kidney, thyroid problems*
pancreas or gallbladder problems TELL YOUR HEALTHCARE PROVIDER IF YOU ARE:*
PREGNANT OR PLANNING TO BECOME PREGNANT. Prolonged use of NUCYNTAÂ ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated*
BREASTFEEDING. Not recommended during treatment with NUCYNTAÂ ER. Itmay harm your baby
*
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTAÂ ER with certain other medicines can cause serious side effects WHEN TAKING NUCYNTAÂ ER:*
Do not change your dose. Take NUCYNTAÂ ER exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed*
Take your prescribed dose every 12Â hours, at the same time every day. Do not take more than your prescribed dose in 24Â hours. If you miss a dose, take your next dose at your usual time*
Swallow NUCYNTAÂ ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject NUCYNTAÂ ER because this may cause you to overdoseand die
IMPORTANT SAFETY INFORMATION ABOUT NUCYNTAÂ ER WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHERCNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE NUCYNTAÂ 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 NUCYNTAÂ ER, and monitor all patients regularly for the development of these behaviorsand conditions.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to*
complete a REMS‑compliant education program,*
counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,*
emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist,and
*
consider other tools to improve patient, household, and communitysafety.
LIFE-THREATENING RESPIRATORY DEPRESSION Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTAÂ ER. Monitor for respiratory depression, especially during initiation of NUCYNTAÂ ER or following a dose increase. Instruct patients to swallow NUCYNTAÂ ER tablets whole; crushing, chewing, or dissolving NUCYNTAÂ ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol. ACCIDENTAL INGESTION Accidental ingestion of even one dose of NUCYNTAÂ ER, especially by children, can result in a fatal overdose of tapentadol. NEONATAL OPIOID WITHDRAWAL SYNDROME Prolonged use of NUCYNTAÂ ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. INTERACTION WITH ALCOHOL Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking NUCYNTAÂ ER. The co-ingestion of alcohol with NUCYNTAÂ ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNSDEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.*
Reserve concomitant prescribing of NUCYNTAÂ ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.*
Limit dosages and durations to the minimum required.*
Follow patients for signs and symptoms of respiratory depression andsedation.
*
CALL YOUR HEALTHCARE PROVIDER IF THE DOSE YOU ARE TAKING DOES NOTCONTROL YOUR PAIN
*
DO NOT STOP TAKING NUCYNTA ER WITHOUT TALKING TO YOUR HEALTHCAREPROVIDER
*
Dispose of expired, unwanted, or unused NUCYNTAÂ ER by promptly flushing down the toilet if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines WHILE TAKING NUCYNTAÂ ER DO NOT:*
Drive or operate heavy machinery until you know how NUCYNTAÂ ER affects you. NUCYNTAÂ ER can make you sleepy, dizzy, or lightheaded*
Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with NUCYNTAÂ ER may cause you to overdose and die THE POSSIBLE SIDE EFFECTS OF NUCYNTAÂ ER ARE:*
constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe GET EMERGENCY MEDICAL HELP IF YOU HAVE:*
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion*
agitation, hallucinations, coma, feeling overheated, or heavy sweating These are not all the possible side effects of NUCYNTA ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088 . FOR MORE INFORMATION, GO TO dailymed.nlm.nih.gov . PLEASE SEE FULL PRESCRIBING INFORMATION , INCLUDING BOXED WARNING AND MEDICATION GUIDE, OR SPEAK TO YOUR HEALTHCARE PROVIDER IF YOU HAVE QUESTIONSABOUT NUCYNTA ER.
INDICATIONS AND USAGE NUCYNTA® (TAPENTADOL) TABLETS ARE:*
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain in adults when other pain treatments, such as non-opioid pain medicines, do not treat your pain well enough or you cannot tolerate them*
An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death IMPORTANT INFORMATION ABOUT NUCYNTAÂ TABLETS:*
GET EMERGENCY HELP RIGHT AWAY IF YOU TAKE TOO MUCH NUCYNTA (OVERDOSE) TABLETS. When you first start taking NUCYNTAÂ tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur*
Taking NUCYNTAÂ tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death*
Never give anyone else your NUCYNTAÂ tablets. They could die from taking it. Selling or giving away NUCYNTAÂ tablets is against the law*
Store NUCYNTAÂ tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to thehome
DO NOT TAKE NUCYNTAÂ TABLETS IF YOU HAVE:*
severe asthma, trouble breathing, or other lung problems*
a bowel blockage or have narrowing of the stomach or intestines BEFORE TAKING NUCYNTAÂ TABLETS, TELL YOUR HEALTHCARE PROVIDER IF YOUHAVE A HISTORY OF:
*
head injury, seizures*
problems urinating
*
abuse of street or prescription drugs, alcohol addiction, or mentalhealth problems
*
liver, kidney, thyroid problems*
pancreas or gallbladder problems TELL YOUR HEALTHCARE PROVIDER IF YOU ARE:*
PREGNANT OR PLANNING TO BECOME PREGNANT. Prolonged use of NUCYNTAÂ tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized andtreated
*
BREASTFEEDING. NUCYNTAÂ tablets pass into breast milk and may harmyour baby
*
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTAÂ tablets with certain other medicines can cause serious side effects that could lead to death WHEN TAKING NUCYNTAÂ TABLETS:*
Do not change your dose. Take NUCYNTAÂ tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed*
Take your prescribed dose every 4-6Â hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time*
Call your healthcare provider if the dose you are taking does notcontrol your pain
*
If you have been taking NUCYNTAÂ tablets regularly, do not stop taking NUCYNTAÂ tablets without talking to your healthcare provider IMPORTANT SAFETY INFORMATION ABOUT NUCYNTAÂ TABLETS WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE NUCYNTAÂ tablets expose 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 NUCYNTAÂ tablets, and monitor all patients regularly for the development of these behaviors and conditions. OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to*
complete a REMS‑compliant education program,*
counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,*
emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist,and
*
consider other tools to improve patient, household, and communitysafety.
LIFE-THREATENING RESPIRATORY DEPRESSION Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTAÂ tablets. Monitor for respiratory depression, especially during initiation of NUCYNTAÂ tablets or following a doseincrease.
ACCIDENTAL INGESTION Accidental ingestion of even one dose of NUCYNTAÂ tablets, especially by children, can result in a fatal overdose of tapentadol. NEONATAL OPIOID WITHDRAWAL SYNDROME Prolonged use of NUCYNTAÂ tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNSDEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.*
Reserve concomitant prescribing of NUCYNTAÂ tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.*
Limit dosages and durations to the minimum required.*
Follow patients for signs and symptoms of respiratory depression andsedation.
*
Dispose of expired, unwanted, or unused NUCYNTAÂ tablets by promptly flushing down the toilet if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines WHILE TAKING NUCYNTAÂ TABLETS, DO NOT:*
Drive or operate heavy machinery until you know how NUCYNTAÂ tablets affect you. NUCYNTAÂ tablets can make you sleepy, dizzy, orlightheaded
*
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with NUCYNTAÂ tablets may cause you to overdose and die THE POSSIBLE SIDE EFFECTS OF NUCYNTAÂ TABLETS:*
constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe GET EMERGENCY MEDICAL HELP IF YOU HAVE:*
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion These are not all the possible side effects of NUCYNTA tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088 . FOR MORE INFORMATION, GO TO dailymed.nlm.nih.gov . PLEASE SEE FULL PRESCRIBING INFORMATION , INCLUDING BOXED WARNING AND MEDICATION GUIDE, OR SPEAK TO YOUR HEALTHCARE PROVIDER IF YOU HAVE QUESTIONS ABOUT NUCYNTA TABLETS.Top
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NUCYNTAÂ ER and NUCYNTA are trademarks of Assertio Therapeutics, Inc.or
its related companies. © 2019 Collegium Pharmaceutical, Inc. All rights reserved. PP-NUER-US-0399 10/19 I AM A HEALTHCARE PROFESSIONAL This site contains information for licensed healthcare professionals in the United States. By entering this website you acknowledge that you are a licensed healthcare professional practicing in the UnitedStates.
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