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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 chat video other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, white oval tablet u03. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

If you are a consumer or patient please visit this version. 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. 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 adose increase [see WARNINGS ]. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets[see WARNINGS ].

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Risk cannot be ruled out during pregnancy. What is the most important information I should know about acetaminophen and hydrocodone? Keep the medication in a place where others cannot get to it. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice yellowing of your skin or eyes. Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. Hydrocodone is an opioid pain medication, sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone. What should I discuss with my healthcare provider before taking acetaminophen and hydrocodone?

Keep the medication in a place where others cannot get to it. A narcotic antagonist should not be administered in theabsence of clinically significant respiratory or cardiovascular depression.

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. Keep this and all medication out of the reach of children.

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 ].

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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.

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The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Hydrocodone bitartrate and acetaminophen tablets with benzodiazepines or other CNS depressants e. 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. Leave a Reply Cancel reply Your email address will not be published. Follow patients closely for signs and symptoms of respiratory depression and sedation. Hepatotoxicity Acetaminophenhas been associated with cases of acute liver failure, at times resulting inliver transplant and death. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Consider these risks when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets. Inactive Ingredients. The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. Hydrocodone suppresses the cough reflex;as with all narcotics, caution should be exercised when hydrocodone bitartrateand acetaminophen tablets are used postoperatively and in patients with pulmonarydisease. You should not stop using this medicine suddenly. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly.

If you are a consumer or patient please visit this version. 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.

Product Characteristics. Version Files Apr 26, 6 current download Feb 18, 5 download Nov 22, 4 download Dec 5, 3 download Feb 21, 2 download Dec 2, 1 download. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1. If you are a consumer or patient please visit this version. Accidental Ingestion Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of Hydrocodone bitartrate and acetaminophen tablets[see WARNINGS ]. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy only ifthe potential benefit justifies the potential risk to the fetus. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. Hydrocodonemay cause confusion and over-sedation in the elderly; elderly patientsgenerally should be started on low doses of hydrocodone bitartrate andacetaminophen tablets and observed closely.