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Go PRO to access past versions. Neonatal opioid withdrawal yellow e712, unlike opioid withdrawal syndrome in adults, yellow e712, 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 ].

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:.

Yellow e712

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.

This can cause life-threatening withdrawal symptoms in the baby after it is born.

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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.

Yellow e712

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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Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Elimination of acetaminophen is principally by liver metabolism conjugation and subsequent renal excretion of metabolites. The toxicity of oxycodone and acetaminophen in combination is unknown. The usual adult dosage is one tablet every 6 hours as needed for pain. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0. Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common. Death may occur if breathing becomes too weak. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies to evaluate the carcinogenic potential of the combination of Oxycodone Hydrochloride and Acetaminophen have not been conducted. Not all possible interactions are listed in this medication guide.

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Advise patients to call their prescriber if they take more than the recommended dose. Therefore, the pharmacologic effects of acetaminophen may be increased. Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing. Physical dependence involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug use or if an opiate antagonist is administered. Never share acetaminophen and oxycodone with another person. Geriatric Use Special precaution should be given when determining the dosing amount and frequency of ENDOCET tablets for geriatric patients, since clearance of oxycodone may be slightly reduced in this patient population when compared to younger patients. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. Marketing Information. Maximal Daily Dose. Ask your doctor how to safely stop using the medicine. For more information go to dailymed. Acetaminophen sometimes abbreviated as APAP is contained in many combination medicines. Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products.