Estados Unidos - inglés - NLM (National Library of Medicine)

redpharm drug - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - 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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia 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 ) significant respiratory depression ( see warnings ) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 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 ) known or suspected gastrointestinal obstruction, including paralytic ileus ( see warnings ) - hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see warnings  and adverse reactions ) hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see warnings  and adverse reactions ) controlled substance hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. abuse hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol,  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 opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “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 drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. hydrocodone bitartrate and acetaminophen tablets, like other opioids, can be diverted for non-medical 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 re-evaluation 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 hydrocodone bitartrate and acetaminophen tablets are for oral use only. hydrocodone bitartrate and acetaminophen tablets pose a risk of overdose and death. the risk is increased with concurrent abuse of hydrocodone bitartrate and acetaminophen tablets with alcohol and other central nervous system 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 chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), 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 opioid usage. 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 a long duration 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, warnings ). infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs ( see precautions, pregnancy ).

Estados Unidos - inglés - NLM (National Library of Medicine)

redpharm drug, inc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - 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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia 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 ) significant respiratory depression ( see warnings ) -

Estados Unidos - inglés - NLM (National Library of Medicine)

bausch health us llc - hydrocodone (unii: 6yks4y3wq7) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine (unii: 3u6io1965u) (chlorpheniramine - unii:3u6io1965u) - hydrocodone 10 mg - tussicaps® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules are indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older. tussicaps® extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine. the use of tussicaps® extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression. tussicaps® extended-release capsules are schedule ii narcotics. psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, tussicaps® extended-release capsules should be prescribed and administered with caution. however, psychic dependence is unlikely to develop when tussicaps® extended-release capsules are used for a short time for the treatment of cough. physical dependence, the condition in which continued adminis

Estados Unidos - inglés - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - diphenoxylate hydrochloride (unii: w24od7yw48) (diphenoxylate - unii:73312p173g), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: - pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (cns) depression (see warnings ). - patients with diarrhea associated with pseudomembranous enterocolitis (clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (gi) complications, including sepsis (see warnings ). - patients with known hypersensitivity to diphenoxylate or atropine. - patients with obstructive jaundice. diphenoxylate hydrochloride and atropine sulfate tablets are classified as a schedule v controlled substance by federal regulation. diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. in doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate h

Estados Unidos - inglés - NLM (National Library of Medicine)

american health packaging - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 15 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy attention deficit disorder with hyperactivity – as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poo

Estados Unidos - inglés - NLM (National Library of Medicine)

bryant ranch prepack - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 30 mg - morphine sulfate extended-release tablets are 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. 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 morphine sulfate extended-release tablets 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. - morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. morphine sulfate extended-release tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial

Estados Unidos - inglés - NLM (National Library of Medicine)

shionogi inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg in 5 ml - methylin is indicated for the treatment of: - attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years of age and older - narcolepsy methylin is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylin. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylin, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary published studies

Estados Unidos - inglés - NLM (National Library of Medicine)

bryant ranch prepack - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see  warnings ). - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see  warnings ). acetaminophen and codeine phosphate tab

Estados Unidos - inglés - NLM (National Library of Medicine)

bryant ranch prepack - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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/long-acting opioid formulations [see warnings and precautions (5.1)] , reserve fentanyl transdermal system 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 o

Estados Unidos - inglés - NLM (National Library of Medicine)

bryant ranch prepack - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. 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/long-acting opioid formulations [see warnings and precautions (5.1)] , reserve fentanyl transdermal system 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 o