USA - engelsk - NLM (National Library of Medicine)

akorn - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), homatropine methylbromide (unii: 68jrs2hc1c) (methylhomatropine - unii:p97ogj7l1l) - hydrocodone bitartrate 5 mg in 5 ml - hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in patients 18 years of age and older. important limitations of use: hydrocodone bitartrate and homatropine methylbromide is contraindicated for: hydrocodone bitartrate and homatropine methylbromide is also contraindicated in patients with: risk summary hydrocodone bitartrate and homatropine methylbromide is not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate and homatropine methylbromide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (see data). reproductive toxicity studies have not been cond

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 10 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration [see warnings] , reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen 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. hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: -   significant respiratory depression [see warnings ] -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] -   hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see warnings, adverse reactions] controlled substance hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. abuse hydrocodone bitartrate and acetaminophen tablets contains hydrocodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings]. 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 hydrocodone bitartrate and acetaminophen tablets 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 hydrocodone bitartrate and acetaminophen tablets with alcohol and 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 hydrocodone bitartrate and acetaminophen tablets abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and acetaminophen 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. hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets abuse of hydrocodone bitartrate and acetaminophen tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and acetaminophen tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. dependence : 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 hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and acetaminophen 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, and warnings]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy].

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 2.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation ) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (see warnings ) , reserve hydrocodone bitartrate and ibuprofen 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 hydrocodone bitartrate and ibuprofen 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. hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with: - significant respiratory depression (see warnings: life-threatening respiratory depression ) . - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings: life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients ) . - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings: risks of use in patients with gastrointestinal conditions ) . - known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product (see warnings: anaphylactic reactions, serious skin reactions ) . patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients (see warnings: anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity ) . - in the setting of coronary artery bypass graft (cabg) surgery (see warnings: cardiovascular thrombotic events ) . controlled substance hydrocodone bitartrate and ibuprofen contains hydrocodone, a schedule ii controlled substance. abuse hydrocodone bitartrate and ibuprofen contains hydrocodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see warnings ) . 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 hydrocodone bitartrate and ibuprofen 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 hydrocodone bitartrate and ibuprofen with alcohol and 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 hydrocodone bitartrate and ibuprofen abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and ibuprofen 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. hydrocodone bitartrate and ibuprofen, 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 hydrocodone bitartrate and ibuprofen abuse of hydrocodone bitartrate and ibuprofen poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and ibuprofen with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. dependence 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 hydrocodone bitartrate and ibuprofen in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and ibuprofen 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 hydrocodone bitartrate and ibuprofen, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and ibuprofen 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, and   warnings ) . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see pregnancy ) .

USA - engelsk - NLM (National Library of Medicine)

pai holdings, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 7.5 mg in 15 ml - hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see  warnings ], reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen oral solution is contraindicated in patients with: • significant respiratory depression [see warnings ] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] • known or suspected gastrointestinal obstruc

USA - engelsk - NLM (National Library of Medicine)

sentynl therapeutics, inc. - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate 2 mg - levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve levorphanol tartrate 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 levorphanol tartrate tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to levorphanol or any of the formulation excipients (e.g., anaphylaxis) [see wa

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings] reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): butorphanol tartrate nasal spray 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. butorphanol tartrate nasal spray is contraindicated in: butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance. butorphanol tartrate nasal spray contains butorphanol, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings] . 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 butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray with alcohol and 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 butorphanol tartrate nasal spray abuse include those with a history of prolonged use of any opioid, including products containing butorphanol, those with a history of drug or alcohol abuse, or those who use butorphanol tartrate nasal spray 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. butorphanol tartrate nasal spray, 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 butorphanol tartrate nasal spray abuse of butorphanol tartrate nasal spray poses a risk of overdose and death. the risk is increased with concurrent use of butorphanol tartrate nasal spray with alcohol and/or other cns depressants. 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 butorphanol tartrate nasal spray in a patient physically dependent on opioids. rapid tapering of butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray, gradually taper the dosage using a patient-specific plan that considers the following: the dose of butorphanol tartrate nasal spray 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, and warnings] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy] .

USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings), reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) butorphanol tartrate nasal spray is contraindicated in: butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance. butorphanol tartrate nasal spray contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. butorphanol tartrate nasal spray can be abused and is subject to misuse, addiction, and criminal diversion (see warnings). all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of

USA - engelsk - NLM (National Library of Medicine)

apotex corp. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use : because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see warnings] reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia butorphanol tartrate nasal spray 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. butorphanol tartrate nasal spray is contraindicated in: - patients with significant respiratory depression [see warnings] - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - patients with hypersensitivity to butorphanol tartrate, the preservative benzethonium chloride, or any of the formulation excipients (e.g., anaphylaxis) [see warnings]) controlled substance butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance.   abuse butorphanol tartrate nasal spray contains butorphanol tartrate, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings].   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 butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray with alcohol and 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 butorphanol tartrate nasal spray abuse include those with a history of prolonged use of any opioid, including products containing butorphanol tartrate, those with a history of drug or alcohol abuse, or those who use butorphanol tartrate nasal spray 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.     butorphanol tartrate nasal spray, 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 butorphanol tartrate nasal spray abuse of butorphanol tartrate nasal spray poses a risk of overdose and death. the risk is increased with concurrent use of butorphanol tartrate nasal spray with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv.   dependence 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 butorphanol tartrate nasal spray in a patient physically dependent on opioids. rapid tapering of butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray, gradually taper the dosage using a patient-specific plan that considers the following: the dose of butorphanol tartrate nasal spray 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, and warnings].   infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see  pregnancy].

USA - engelsk - NLM (National Library of Medicine)

mikart, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 7.5 mg in 15 ml - hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen oral solution is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see

USA - engelsk - NLM (National Library of Medicine)

acella pharmaceuticals, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - hydrocodone bitartrate 5 mg in 5 ml - hydrocodone bitartrate and chlorpheniramine maleate oral solution is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. important limitations of use not indicated for pediatric patients under 18 years of age [see use in specific populations ( 8.4)] . hydrocodone bitartrate and chlorpheniramine maleate oral solution is contraindicated in: - patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine maleate or any of the inactive ingredients of hydrocodone bitartrate and chlorpheniramine maleate oral solution. - patients receiving maoi therapy or within 14 days of stopping such therapy. - patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of hydrocodone bitartrate and chlorpheniramine maleate oral solut