U01 white round

Limitations of Use Because of the risks of addiction, abuse, and misuseu01 white round, 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 u01 white round contains 5 mg hydrocodone bitartrate and mg acetaminophen. Each tablet contains 7.

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.

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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. Risks from concomitant use with Benzodiazepines or other CNS Depressants Concomitant use of opiods with benzodiazepines or other central nervous system CNS depressants including alcohol, may result in profound sedation, respiratory depression, coma, and death. Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

Expired, unwanted, or unused Hydrocodone Bitartrate and Acetaminophen Tablets should be disposed of by flushing the u01 white round medication down the toilet if a drug take-back option is not readily available, u01 white round. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

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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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Rapid tapering of Hydrocodone Bitartrate and Acetaminophen Tablets in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain. Hydrocodone bitartrate and acetaminophen tablets USP are, indicated for the relief of moderate to moderately severe pain. Each tablet contains 7. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Risks Specific to Abuse of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone bitartrate and acetaminophen tablets are for oral use only. Other adverse reactions include Central Nervous System Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Hydrocodone bitartrate and acetaminophen tablets can make you sleepy, dizzy, or lightheaded. Long-term studies to evaluate the carcinogenic potential of the combination of Hydrocodone Bitartrate and Acetaminophen Tablets have not been conducted. Each tablet contains 5 mg hydrocodone bitartrate and mg acetaminophen.

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Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Acetaminophen Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Acetaminophen MG Hydrocodone Bitartrate 7. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Food and Drug Administration. Taking hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death. Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Intravenous NAC may be administered when circumstances preclude oral administration. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Nursing Mothers Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known.