United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - acetaminophen 325 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, even at recommended doses [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 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] • hypersensitiv

United States - English - NLM (National Library of Medicine)

epic pharma, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate 5 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. 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 acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 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: hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, 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 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. abuse of hydrocodone bitartrate and acetaminophen tablets pose 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. both tolerance and physical dependence can develop during chronic 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 ].

United States - English - NLM (National Library of Medicine)

par pharmaceutical - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - acetaminophen 325 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 warnings ] - hypersensitivity to hydrocodon

United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - 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, even at recommended doses (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 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., anaphyla

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - acetaminophen 325 mg - hydrocodone bitartrate and acetaminophen tablets, usp are indicated for the management of moderate to moderately severe 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 tablets, usp for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): hydrocodone bitartrate and acetaminophen tablets, usp are contraindicated in patients with:

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - acetaminophen 325 mg in 15 ml - hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. misuse abuse and diversion of opioids hydrocodone bitartrate oral solution contains hydrocodone, an opioid agonist, and is a schedule ii controlled substance. hydrocodone bitartrate oral solution, and other opioids used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a t

United States - English - NLM (National Library of Medicine)

direct rx - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets, usp are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen, or any other component of this product. patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. misuse, abuse, and diversion of opioids hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule iii controlled substance. hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and crav

United States - English - NLM (National Library of Medicine)

directrx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate and acetaminophen tablets, usp 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, even at recommended doses [see warnings], reserve hydrocodone bitartrate and acetaminophen tablets, usp 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 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

United States - English - NLM (National Library of Medicine)

direct_rx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - 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, even at recommended doses [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 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

United States - English - NLM (National Library of Medicine)

direct_rx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - 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, even at recommended doses [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 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