Nucynta Er

Nucynta Er Manufacturers

• Lake Erie Medical Dba Quality Care Products Llc
  

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  Nucynta Er | Lake Erie Medical Dba Quality Care Products Llc

  

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  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 72 hours of initiating therapy with NUCYNTA® ER [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of NUCYNTA® ER:

  Total daily dose, potency, and kind of any prior analgesic the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of tapentadol needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  NUCYNTA® ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].

  NUCYNTA® ER is administered at a frequency of twice daily (every 12 hours).

  Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see Serotonin Syndrome Risk (5.11)]. Although the maximum approved total daily dose of NUCYNTA® immediate-release formulation is 600 mg per day, the maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed a total daily dose of NUCYNTA® ER of 500 mg.

  Use of NUCYNTA® ER as the First Opioid Analgesic

  Initiate NUCYNTA® ER therapy with the 50 mg tablet twice daily (at 12 hour intervals).

  Conversion from NUCYNTA® to NUCYNTA® ER

  Patients can be converted from NUCYNTA® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTA® and dividing it into two equal doses of NUCYNTA® ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTA® four times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day.

  Conversion from other Opioids to NUCYNTA® ER

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. As such, it is safer to underestimate a patient's 24-hour NUCYNTA® ER requirement and provide rescue medication (e.g., immediate-release opioid or non-opioid) than to overestimate and manage an adverse reaction. In general, begin with half of the estimated daily tapentadol requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release rescue medication.

  Published relative potency/equianalgesia data are available and may be referred to in clinical practice guidelines such as those published by authorities in the field of pain medicine, but such ratios are approximations. Consider contacting your specific state medical or pharmacy professional societies for further information on how to safely convert patients from one opioid to another.

  2.2 Titration and Maintenance of Therapy

  Individually titrate NUCYNTA® ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three days. In clinical studies, efficacy with NUCYNTA® ER was demonstrated relative to placebo in the dosage range of 100 mg to 250 mg twice daily [see Clinical Studies (14)].

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the NUCYNTA® ER dose to decrease the level of pain.

  Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid or non-opioid medication.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.3 Discontinuation of NUCYNTA® ER

  When the patient no longer requires therapy with NUCYNTA® ER tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.4 Patients with Hepatic Impairment

  The use of NUCYNTA® ER in patients with severe hepatic impairment (Child-Pugh Score 10–15) is not recommended.

  In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), initiate treatment using 50 mg NUCYNTA® ER and administer no more frequently than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER once daily [see Clinical Pharmacology (12.3)].

  No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Warnings and Precautions (5.15) and Clinical Pharmacology (12.3)].

  2.5 Patients with Renal Impairment

  No dosage adjustment is recommended in patients with mild or moderate renal impairment. NUCYNTA® ER use in patients with severe renal impairment is not recommended [see Warnings and Precautions (5.16) and Clinical Pharmacology (12.3)].

  2.6 Elderly Patients

  In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses [see Clinical Pharmacology (12.3)].

  2.7 Administration of NUCYNTA® ER

  Instruct patients to swallow NUCYNTA® ER tablets whole. The tablets are not to be cut, crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of tapentadol [see Warnings and Precautions (5.1, 5.2)].

  Instruct patients to take NUCYNTA® ER one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.2), and Patient Counseling Information (17)].

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• Lake Erie Medical Dba Quality Care Products Llc
  

  ×

  Nucynta Er | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 72 hours of initiating therapy with NUCYNTA® ER [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of NUCYNTA® ER:

  Total daily dose, potency, and kind of any prior analgesic the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of tapentadol needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  NUCYNTA® ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].

  NUCYNTA® ER is administered at a frequency of twice daily (every 12 hours).

  Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see Serotonin Syndrome Risk (5.11)]. Although the maximum approved total daily dose of NUCYNTA® immediate-release formulation is 600 mg per day, the maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed a total daily dose of NUCYNTA® ER of 500 mg.

  Use of NUCYNTA® ER as the First Opioid Analgesic

  Initiate NUCYNTA® ER therapy with the 50 mg tablet twice daily (at 12 hour intervals).

  Conversion from NUCYNTA® to NUCYNTA® ER

  Patients can be converted from NUCYNTA® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTA® and dividing it into two equal doses of NUCYNTA® ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTA® four times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day.

  Conversion from other Opioids to NUCYNTA® ER

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variation in the relative potency of different opioid drugs and formulations. Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. As such, it is safer to underestimate a patient's 24-hour NUCYNTA® ER requirement and provide rescue medication (e.g., immediate-release opioid or non-opioid) than to overestimate and manage an adverse reaction. In general, begin with half of the estimated daily tapentadol requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release rescue medication.

  Published relative potency/equianalgesia data are available and may be referred to in clinical practice guidelines such as those published by authorities in the field of pain medicine, but such ratios are approximations. Consider contacting your specific state medical or pharmacy professional societies for further information on how to safely convert patients from one opioid to another.

  2.2 Titration and Maintenance of Therapy

  Individually titrate NUCYNTA® ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.

  Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three days. In clinical studies, efficacy with NUCYNTA® ER was demonstrated relative to placebo in the dosage range of 100 mg to 250 mg twice daily [see Clinical Studies (14)].

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the NUCYNTA® ER dose to decrease the level of pain.

  Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid or non-opioid medication.

  If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy regularly (e.g., every 6 to 12 months) as appropriate.

  2.3 Discontinuation of NUCYNTA® ER

  When the patient no longer requires therapy with NUCYNTA® ER tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.4 Patients with Hepatic Impairment

  The use of NUCYNTA® ER in patients with severe hepatic impairment (Child-Pugh Score 10–15) is not recommended.

  In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), initiate treatment using 50 mg NUCYNTA® ER and administer no more frequently than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER once daily [see Clinical Pharmacology (12.3)].

  No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Warnings and Precautions (5.15) and Clinical Pharmacology (12.3)].

  2.5 Patients with Renal Impairment

  No dosage adjustment is recommended in patients with mild or moderate renal impairment. NUCYNTA® ER use in patients with severe renal impairment is not recommended [see Warnings and Precautions (5.16) and Clinical Pharmacology (12.3)].

  2.6 Elderly Patients

  In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses [see Clinical Pharmacology (12.3)].

  2.7 Administration of NUCYNTA® ER

  Instruct patients to swallow NUCYNTA® ER tablets whole. The tablets are not to be cut, crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of tapentadol [see Warnings and Precautions (5.1, 5.2)].

  Instruct patients to take NUCYNTA® ER one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.2), and Patient Counseling Information (17)].

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• Janssen Pharmaceuticals, Inc.
  

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  Nucynta Er | Janssen Pharmaceuticals, Inc.

  

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  2.1 Initial Dosing

  NUCYNTA® ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with NUCYNTA® ER [see Warnings and Precautions (5.2)].

  NUCYNTA® ER tablets must be taken whole. Crushing, chewing, or dissolving NUCYNTA® ER tablets will result in uncontrolled delivery of tapentadol and can lead to overdose or death [see Warnings and Precautions (5.2)].

  NUCYNTA® ER is administered at a frequency of twice daily (every 12 hours).

  Discontinue all other tapentadol and tramadol products when beginning and while taking NUCYNTA® ER [see Warnings and Precautions (5.10)]. Although the maximum approved total daily dose of NUCYNTA® immediate-release formulation is 600 mg per day, the maximum total daily dose of NUCYNTA® ER is 500 mg. Do not exceed a total daily dose of NUCYNTA® ER of 500 mg.

  Use of NUCYNTA® ER as the First Opioid Analgesic

  Initiate treatment with NUCYNTA® ER with the 50 mg tablet orally twice daily (approximately every 12 hours).

  Use of NUCYNTA® ER in Patients who are not Opioid Tolerant

  The starting dose for patients who are not opioid tolerant is NUCYNTA® ER 50 mg orally twice daily (approximately every 12 hours). Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day or an equianalgesic dose of another opioid.

  Conversion from NUCYNTA® to NUCYNTA® ER

  Patients can be converted from NUCYNTA® to NUCYNTA® ER using the equivalent total daily dose of NUCYNTA® and dividing it into two equal doses of NUCYNTA® ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTA® four times per day (200 mg/day) may be converted to 100 mg NUCYNTA® ER twice a day.

  Conversion from Other Opioids to NUCYNTA® ER

  There are no established conversion ratios for conversion from other opioid to NUCYNTA® ER defined by clinical trials. Discontinue all other around-the-clock opioid drugs when NUCYNTA® ER therapy is initiated.

  While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral tapentadol requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral tapentadol requirements which could result in adverse reactions.

  In general, as with other opioid analgesics, begin with half of the estimated daily tapentadol requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release rescue medication.

  Conversion from Methadone to NUCYNTA® ER

  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate NUCYNTA® ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving NUCYNTA® ER to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

  Titrate patients to adequate analgesia with dose increases of 50 mg no more than twice daily every three days. In clinical studies, efficacy with NUCYNTA® ER was demonstrated relative to placebo in the dosage range of 100 mg to 250 mg twice daily [see Clinical Studies (14)].

  Patients who experience breakthrough pain may require a dose increase of NUCYNTA® ER, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the NUCYNTA® ER dose.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 Discontinuation of NUCYNTA® ER

  When the patient no longer requires therapy with NUCYNTA® ER tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient.

  2.4 Patients with Hepatic Impairment

  The use of NUCYNTA® ER in patients with severe hepatic impairment (Child-Pugh Score 10–15) is not recommended.

  In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), initiate treatment using 50 mg NUCYNTA® ER and administer no more frequently than once every 24 hours. The maximum recommended dose for patients with moderate hepatic impairment is 100 mg of NUCYNTA® ER per day [see Clinical Pharmacology (12.3)].

  No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].

  2.5 Patients with Renal Impairment

  No dosage adjustment is recommended in patients with mild or moderate renal impairment. Use of NUCYNTA® ER in patients with severe renal impairment is not recommended [see Warnings and Precautions (5.15) and Clinical Pharmacology (12.3)].

  2.6 Elderly Patients

  In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses [see Clinical Pharmacology (12.3)].

  2.7 Administration of NUCYNTA® ER

  Instruct patients to swallow NUCYNTA® ER tablets whole. The tablets are not to be cut, crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of tapentadol [see Warnings and Precautions (5.1, 5.2)].

  Instruct patients to take NUCYNTA® ER one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions (5.2), and Patient Counseling Information (17)].

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