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

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, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see ]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused ENDOCET should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available.

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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. You should not use this medicine if you are allergic to acetaminophen Tylenol or oxycodone, or if:. Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

NAC therapy should be withheld if the acetaminophen level is below the lower line. Addiction can occur yellow e712 recommended dosages and if the drug is misused or abused. The principal therapeutic action of oxycodone is analgesia.

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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.

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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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Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. Product Characteristics. This effect appears to be drug, concentration and system dependent. What happens if I miss a dose? Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. Vigorous supportive therapy is required in severe intoxication. Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus. The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. The frequency of this possible cross-sensitivity is unknown. Follow patients closely for signs and symptoms of respiratory depression and sedation.

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Product Information. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the ENDOCET dosage. 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 ENDOCET. Monitor patients for respiratory depression and sedation at frequent intervals. Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. These effects appear to increase with the duration of treatment. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Oxycodone is an opioid agonist of the morphine-type. In addition, abuse of opioids can occur in the absence of true addiction. In addition, the 7. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia.