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If you are a consumer or u01 white round 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.

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. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7. Each tablet contains 10 mg hydrocodone bitartrate and mg acetaminophen. Dispense in a tight, light-resis tan t container as defined in the USP with a child-resis tan t closure.

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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:. Hydrocodone bitartrate and acetaminophen tablets USP, for oral administration, are available in a variety of strengths as described in the following table. Each hydrocodone bitartrate and acetaminophen tablet contains:. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined.

Cough Reflex Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised u01 white round hydrocodone bitartrate and acetaminophen tablets are used postoperatively and in patients with pulmonary disease. In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

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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.

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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. Exercise has many benefits for older adults and can help you to live a longer and healthier life. Here are 6 benefits of exercise for older adults and seniors. Natural home remedies and over-the-counter OTC products can be used to temporarily relieve toothache pain until you can visit your dentist. Fibromyalgia is a condition characterized by pain in your muscles and fibrous tissues, accompanied by fatigue, low mood, and sleep problems. Facebook Twitter Email Print. Musculoskeletal disorders - what to know about tests and diagnostic procedures Blood tests, imaging tests and more are used to diagnose musculoskeletal disorders.

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Clinical studies of hydrocodone bitartrate 5 mg and acetaminophen mg did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Nonteratogenic Effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion. In general, dose selection for an elderly patient should be cautious, 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. Instruct patients to seek medical attention immediately upon ingestion of more than 4, milligrams of acetaminophen per day, even if they feel well. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. 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. Intravenous NAC may be administered when circumstances preclude oral administration. The usual adult dosage is one or two tablets every four to six hours as needed for pain. These are not all the possible side effects of hydrocodone bitartrate and acetaminophen tablets. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. 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. Follow patients for respiratory depression and sedation at frequent intervals.

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Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Discontinue hydrocodone bitartrate and acetaminophen tablets if serotonin syndrome is suspected. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with hydrocodone bitartrate and acetaminophen tablets. Do not prescribe hydrocodone bitartrate and acetaminophen tablets for patients with acetaminophen allergy. Hydrocodone Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was Addiction, Abuse, and Misuse Inform patients that the use of hydrocodone bitartrate and acetaminophen tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. Hydromorphone is formed from the O-demethylation of hydrocodone and may contribute to the total analgesic effect of hydrocodone. Hydrocodone bitartrate and acetaminophen tablets USP are, indicated for the relief of moderate to moderately severe pain. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Opioids can cause sleep-related breathing disorders including central sleep apnea CSA and sleep-related hypoxemia. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.