संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

collegium pharmaceutical, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - 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 and pediatric patients aged 6 years and older with a body weight of at least 40kg. limitations of use because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see warnings and precautions (5.1)] , reserve nucynta tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia nucynta tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. nucynta tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.8)] - known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see warnings and precautions (5.12)] - hypersensitivity to tapentadol (e.g., anaphylaxis, angioedema) or to any other ingredients of the product [see adverse reactions (6.2)] - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days [see drug interactions (7)] risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] . available data with nucynta tablets are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. there are risks to the mother and infant associated with use of nucynta tablets for an extended period of time during pregnancy (see clinical considerations). in animal reproduction studies, embryofetal mortality and structural malformations were observed with subcutaneous administration of tapentadol during organogenesis to rabbits and delays in skeletal maturation were observed in rats at exposures equivalent to and less than the maximum recommended human dose (mrhd), respectively. when administered to pregnant rats during organogenesis and through lactation, increased pup mortality was noted following oral tapentadol exposures to doses equivalent to the mrhd [see data] . based on animal data, advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse reaction. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.4)] . labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. nucynta tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including nucynta tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data tapentadol hcl was evaluated for teratogenic effects in pregnant rats and rabbits following subcutaneous exposure during organogenesis. when tapentadol was administered twice daily by the subcutaneous route in rats at dose levels of 10, 20, or 40 mg/kg/day [producing up to 1 times the plasma exposure at the maximum recommended human dose (mrhd) of 700 mg/day based on an area under the time-curve (auc) comparison], no teratogenic effects were observed. evidence of embryofetal toxicity included transient delays in skeletal maturation (i.e. reduced ossification) at the 40 mg/kg/day dose which was associated with significant maternal toxicity. administration of tapentadol hcl in rabbits at doses of 4, 10, or 24 mg/kg/day by subcutaneous injection [producing 0.2, 0.6, and 1.85 times the plasma exposure at the mrhd based on an auc comparison] revealed embryofetal toxicity at doses ≥10 mg/kg/day. findings included reduced fetal viability, skeletal delays and other variations. in addition, there were multiple malformations including gastroschisis/thoracogastroschisis, amelia/phocomelia, and cleft palate at doses ≥10 mg/kg/day and above, and ablepharia, encephalopathy, and spina bifida at the high dose of 24 mg/kg/day. embryofetal toxicity, including malformations, may be secondary to the significant maternal toxicity observed in the study. in a study of pre- and postnatal development in rats, oral administration of tapentadol at doses of 20, 50, 150, or 300 mg/kg/day to pregnant and lactating rats during the late gestation and early postnatal period [resulting in up to 1.7 times the plasma exposure at the mrhd on an auc basis] did not influence physical or reflex development, the outcome of neurobehavioral tests or reproductive parameters. treatment-related developmental delay was observed, including incomplete ossification, and significant reductions in pup body weights and body weight gains at doses associated with maternal toxicity (150 mg/kg/day and above). at maternal tapentadol doses ≥150 mg/kg/day, a dose-related increase in pup mortality was observed through postnatal day 4. risk summary there are no data on the presence of tapentadol in human milk, the effects on the breastfed infant, or the effects on milk production. tapentadol is present in animal milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. infants exposed to nucynta tablets through breast milk should be monitored for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nucynta tablets and any potential adverse effects on the breastfed infant from nucynta tablets or from the underlying maternal condition. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), clinical pharmacology (12.2)]. the safety and effectiveness of nucynta (tapentadol) tablets in pediatric patients ages 6 years and older who weigh at least 40 kg have been established. use of nucynta (tapentadol) tablets in pediatric patients ages 6 years and older who weigh at least 40 kg is based on one randomized, double-blind, placebo-controlled, multiple-dose efficacy and safety study of nucynta (tapentadol) oral solution in 175 pediatric patients from birth to 17 years of age who had undergone surgery that would reliably produce moderate to severe pain and supported by pharmacokinetic and safety data from three open-label, single-dose studies of nucynta (tapentadol) oral solution in 129 patients from birth to 17 years of age with moderate to severe acute pain from a surgical procedure [see clinical studies (14.2)] . the safety and effectiveness of nucynta (tapentadol) tablets in pediatric patients less than 6 years of age have not been established. in pediatric patients less than 6 years of age, nucynta (tapentadol) oral solution did not demonstrate efficacy compared to placebo when evaluated in one randomized, double-blind, placebo-controlled, multiple-dose study in 175 pediatric patients from birth to 17 years of age who had undergone surgery that would reliably produce moderate to severe pain [see clinical studies (14.2)] . the safety and effectiveness of nucynta (tapentadol) tablets in pediatric patients who weigh less than 40 kg have not been established because the recommended dosage cannot be achieved with available tablet strengths. consider use of another nucynta product, such as nucynta (tapentadol) oral solution, in patients who cannot swallow oral tablets or who weigh less than 40 kg [see dosage and administration (2.3)] . nucynta (tapentadol) tablets have not been studied in pediatric patients with hepatic or renal impairment; therefore, use in these populations is not recommended [see dosage and administration (2.4)] . of the total number of patients in phase 2/3 double-blind, multiple-dose clinical studies of nucynta tablets, 19% were 65 and over, while 5% were 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. the rate of constipation was higher in subjects greater than or equal to 65 years than those less than 65 years (12% vs. 7%). elderly patients (aged 65 years or older) may have increased sensitivity to tapentadol. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of nucynta tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.2)] . tapentadol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. administration of tapentadol resulted in higher exposures and serum levels of tapentadol in subjects with impaired hepatic function compared to subjects with normal hepatic function [see clinical pharmacology (12.3)] . use of nucynta tablets are not recommended in patients with severe hepatic impairment (child-pugh score 10 to 15) [see warnings and precautions (5.17)] . the dose of nucynta tablets should be reduced in patients with moderate hepatic impairment (child-pugh score 7 to 9) [see dosage and administration (2.5)]. no dosage adjustment is recommended in patients with mild hepatic impairment (child-pugh score 5 to 6) [see warnings and precautions (5.17), clinical pharmacology (12.3)]. use of nucynta tablets in patients with severe renal impairment (creatinine clearance less than 30 ml/minute) is not recommended. no dosage adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30-90 ml/minute) [see warnings and precautions (5.18), clinical pharmacology (12.1)] . nucynta tablets contain tapentadol, a schedule ii controlled substance. nucynta tablets contain tapentadol, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of nucynta tablets increase risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of nucynta tablets with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of nucynta tablet abuse include those with a history of prolonged use of any opioid, including products containing tapentadol, those with a history of drug or alcohol abuse, or those who use nucynta tablets in combination with other abused drugs. "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. nucynta tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of nucynta tablets abuse of nucynta tablets pose a risk of overdose and death. the risk is increased with concurrent use of nucynta tablets with alcohol and/or other central nervous system depressants. nucynta tablets are approved for oral use only. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue nucynta tablets in a patient physically dependent on opioids. rapid tapering of nucynta tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing nucynta tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of nucynta tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration (2.7), and warnings and precautions (5.13)]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - 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) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 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 [see warnings and precautions (5.1)] , 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. nucynta er is contraindicated in patients wi

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

collegium pharmaceutical, inc. - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - nucynta er (tapentadol) is indicated for the management of: - severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. - severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (dpn) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions (5.1)] , 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. nucynta er is contraindicated in patients with: - significant respiratory depression - acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment - known or suspected gastrointestinal obstruction, including paralytic ileus - hypersensitivity (e.g., anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product [see adverse reactions (6.2)] . - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days [see drug interactions (7)]. risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)]. available data with nucynta er are insufficient to inform a drug- associated risk for major birth defects and miscarriage or adverse maternal outcomes. in animal reproduction studies, embryofetal mortality and structural malformations were observed with subcutaneous administration of tapentadol during organogenesis to rabbits and delays in skeletal maturation were observed in rats at exposures equivalent to and less than the maximum recommended human dose (mrhd), respectively. when administered to pregnant rats during organogenesis and through lactation, increased pup mortality was noted following oral tapentadol exposures to doses equivalent to the mrhd [see data] . based on animal data, advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse reaction. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.4)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psychophysiological effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. nucynta er is not recommended for use in pregnant women during and immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including nucynta er, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data tapentadol hcl was evaluated for teratogenic effects in pregnant rats and rabbits following intravenous and subcutaneous exposure during the period of embryofetal organogenesis. when tapentadol was administered twice daily by the subcutaneous route in rats at dose levels of 10, 20, or 40 mg/kg/day [producing up to 1.36 times the plasma exposure at the maximum recommended human dose (mrhd) of 500 mg/day for nucynta er based on an area under the time-curve (auc) comparison], no teratogenic effects were observed. evidence of embryofetal toxicity included transient delays in skeletal maturation (i.e., reduced ossification) at the 40 mg/kg/day dose which was associated with significant maternal toxicity. administration of tapentadol hcl in rabbits at doses of 4, 10, or 24 mg/kg/day by subcutaneous injection [producing 0.3, 0.8, and 2.5 times the plasma exposure at the mrhd based on an auc comparison, respectively] revealed embryofetal toxicity at doses ≥10 mg/kg/day. findings included reduced fetal viability, skeletal delays and other variations. in addition, there were multiple malformations including gastroschisis/thoracogastroschisis, amelia/phocomelia, and cleft palate at doses ≥10 mg/kg/day and above, and ablepharia, encephalopathy, and spina bifida at the high dose of 24 mg/kg/day. embryofetal toxicity, including malformations, may be secondary to the significant maternal toxicity observed in the study. in a study of pre- and postnatal development in rats, oral administration of tapentadol at doses of 20, 50, 150, or 300 mg/kg/day to pregnant and lactating rats during the late gestation and early postnatal period [resulting in up to 2.28 times the plasma exposure at the mrhd on an auc basis] did not influence physical or reflex development, the outcome of neurobehavioral tests or reproductive parameters. at maternal tapentadol doses ≥150 mg/kg/day, a dose-related increase in pup mortality was observed to postnatal day 4. treatment-related developmental delay was observed in the dead pups, including incomplete ossification. in addition, significant reductions in pup body weights and body weight gains at doses associated with maternal toxicity (150 mg/kg/day and above) were seen throughout lactation. risk summary there is insufficient/limited information on the excretion of tapentadol in human or animal breast milk. physicochemical and available pharmacodynamic/toxicological data on tapentadol point to excretion in breast milk and risk to the breastfeeding child cannot be excluded. because of the potential for serious adverse reactions including excess sedation and respiratory depression in a breastfed infant, advise patients that breast feeding is not recommended during treatment with nucynta er. clinical considerations monitor infants exposed to nucynta er through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), nonclinical toxicology (13.1)] . the safety and efficacy of nucynta er in pediatric patients less than 18 years of age have not been established. of the total number of patients in phase 2/3 double-blind, multiple-dose clinical studies of nucynta er, 28% (1023/3613) were 65 years and over, while 7% (245/3613) were 75 years and over. no overall differences in effectiveness or tolerability were observed between these patients and younger patients. elderly patients (aged 65 or older) may have increased sensitivity to tapentadol. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)] . respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of nucynta er slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.8)] . tapentadol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. 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), dosage reduction of nucynta er is recommended [see dosage and administration (2.5)]. no dosage adjustment is recommended in patients with mild hepatic impairment (child-pugh score 5 to 6) [see warnings and precautions (5.16), clinical pharmacology (12.3)] . use of nucynta er in patients with severe renal impairment (creatinine clearance less than 30 ml/minute) is not recommended. no dosage adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30-90 ml/minute) [see warnings and precautions (5.17), clinical pharmacology (12.3)] . nucynta er contains tapentadol, a schedule ii controlled substance. nucynta er contains tapentadol, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of nucynta er increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of nucynta er with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of nucynta er abuse include those with a history of prolonged use of any opioid, including products containing tapentadol, those with a history of drug or alcohol abuse, or those who use nucynta er in combination with other abused drugs. "drug-seeking" behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). "doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. nucynta er, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of nucynta er abuse of nucynta er poses a risk of overdose and death. this risk is increased with the concurrent use of nucynta er with alcohol and/or other cns depressants [see warnings and precautions (5.1, 5.3), drug interactions (7)] . nucynta er is approved for oral use only. with parenteral abuse, the inactive ingredients in nucynta er can result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury, embolism and death. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue nucynta er in a patient physically dependent on opioids. rapid tapering of nucynta er in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing nucynta er, gradually taper the dosage using a patient-specific plan that considers the following: the dose of nucynta er the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration (2.6), warnings and precautions (5.3)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

quality care products, llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - 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 [see warnings and precautions (5.1)] , reserve nucynta tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia nucynta tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - known or suspected gastrointestinal obstruction, including suspected paralytic ileus [see warnings and precautions (5.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

quality care products, llc - tapentadol hydrochloride (unii: 71204kii53) (tapentadol - unii:h8a007m585) - 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-term opioid treatment and for which alternative treatment options are inadequate. 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 [see warnings and precautions (5.1)] , 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. nucynta er is contraindicated in patients with: - sign

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tapentadol - prolonged-release tablet - 100 milligram(s) - tapentadol

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tapentadol - prolonged-release tablet - 50 milligram(s) - tapentadol

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

neuraxpharm ireland limited - tapentadol phosphate - prolonged-release tablet - tapentadol

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

neuraxpharm ireland limited - tapentadol phosphate - prolonged-release tablet - tapentadol

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

neuraxpharm ireland limited - tapentadol phosphate - prolonged-release tablet - tapentadol