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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, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of yellow e712 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 ], 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.

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:. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is It may be represented by the following structural formula:. Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.

Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an yellow e712 provider of continuing education CE or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.

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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.

Yellow e712

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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Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. An overdose can be fatal, especially in a child or other person using this medicine without a prescription. Where can I get more information? Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. ENDOCET should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly. Concentration—Adverse Reaction Relationships There is a relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. Go PRO to access past versions. 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.

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The plasma half-life is 1. Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. What are the possible side effects of acetaminophen and oxycodone? Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. 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. Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration. If you miss a dose, take your next dose at your usual time. Acetaminophen Dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. Dizziness or severe drowsiness can cause falls or other accidents.