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Go PRO to access past yellow e712. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

If you are a consumer or patient please visit this version. Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:. Oxycodone Hydrochloride, USP 7. All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 7.

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This medicine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share acetaminophen and oxycodone with another person. Oxycodone can slow or stop your breathing, and may be habit-forming. Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice yellowing of your skin or eyes. 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. Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Acetaminophen Dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. The potential for these risks should not, yellow e712, however, prevent the proper management of pain in any given patient.

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Acetaminophen and oxycodone is a combination medicine used to relieve moderate to severe pain. Acetaminophen and oxycodone may also be used for purposes not listed in this medication guide. Acetaminophen and oxycodone contains an opioide medicine and may be habit-forming. You should not use this medicine if you are allergic to acetaminophen or oxycodone, or if you have:. If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks. Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

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If you are a consumer or patient please visit this version. 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. Neonatal Opioid Withdrawal Syndrome Prolonged use of ENDOCET 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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Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels moderate to excessive of acetaminophen. Bottles of NDC 7. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Boxed Warning Section. Concentration—Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Abuse ENDOCET contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation. If there is no take-back program, flush any unused pills or liquid medicine down the toilet. This can cause life-threatening withdrawal symptoms in the baby after it is born. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Oxymorphone, is formed by the O-demethylation of oxycodone.

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Oxycodone should be used with caution in patients with renal impairment. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. This can cause life-threatening withdrawal symptoms in the baby after it is born. Prolonged use of ENDOCET during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Advise patients not to adjust the medication dose themselves and to consult with their healthcare provider prior to any dosage adjustment. Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. In addition, discontinuation of a concomitantly used cytochrome P 3A4 inducer may result in an increase in oxycodone plasma concentration. Opioid analgesics, including ENDOCET, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Opioid use increases the risk of CSA in a dose-dependent fashion.