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Go PRO to access past versions. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, yellow e712, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant yellow e712 using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see ], yellow e712.

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. Oxycodone, hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:.

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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.

Clinical and laboratory yellow e712 of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Acetaminophen is relatively uniformly distributed throughout most body fluids.

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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 ]. Cytochrome P 3A4 Interaction The concomitant use of ENDOCET with all cytochrome P 3A4 inhibitors may result in an increase in oxycodone 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 oxycodone plasma concentration.

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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:.

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If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the ENDOCET dosage. Oxycodone should be used with caution in patients with renal impairment. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Oxycodone is an opioid pain medication. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Acetaminophen Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon.

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If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Advise patients to call their prescriber if they take more than the recommended dose. Physical dependence and tolerance are not unusual during chronic opioid therapy. The site and mechanism for the analgesic effect of acetaminophen has not been determined. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Mutagenesis The combination of Oxycodone Hydrochloride and Acetaminophen has not been evaluated for mutagenicity. Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. Dizziness or severe drowsiness can cause falls or other accidents.