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Limitations of Use Because of the risks of addiction, abuse, and misusewith opioids, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e, u01 white round. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen.

If you are a consumer or patient please visit this version. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS. Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. It has the following structural formula:.

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If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Cytochrome P 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all Cytochrome P 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P 3A4 inducer may result in an increase in hydrocodone plasma concentrations. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS.

There is no consensus on the best method of managing withdrawal.

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If you are a consumer or patient please visit this version. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ].

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This medicine is known as cyclobenzaprine. Blood tests, imaging tests and more are used to diagnose musculoskeletal disorders. Here's an overview of the tests and procedures used.

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The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Employ other supportive measures including oxygen and vasopressors in the management of circulatory shock and pulmonary edema as indicated. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Call your doctor for medical advice about side effects. The risk of acute liver failure is higher in individuals who ingest alcohol while taking acetaminophen. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.. Instruct patients to take steps to store hydrocodone bitartrate and acetaminophen tablets securely and to dispose of unused Hydrocodone Bitartrate and Acetaminophen Tablets by flushing down the toilet. Drug Interactions Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants including alcohol concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication. Opioids may also obscure the clinical course in a patient with a head injury. Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help right away in the event of a known or suspected overdose [see WARNINGS, Life Threatening Respiratory Depression ]. A Schedule C-II controlled drug subs tan ce.

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Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Follow patients with a history of seizure disorders for worsened seizure control during hydrocodone bitartrate and acetaminophen tablet therapy. Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Call your doctor for medical advice about side effects. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors SSRIs , serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system e. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.