"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(oxycodone hydrochloride and acetaminophen) Extended-release Tablets
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and HEPATOTOXICITY
Addiction, Abuse, and Misuse
XARTEMIS XR exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing XARTEMIS XR, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of XARTEMIS XR. Monitor for respiratory depression, especially during initiation of XARTEMIS XR or following a dose increase. Instruct patients to swallow XARTEMIS XR tablets whole; crushing, chewing, or dissolving XARTEMIS XR can cause rapid release and absorption of a potentially fatal dose of oxycodone [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of XARTEMIS XR, especially in children, can result in a fatal overdose of oxycodone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of XARTEMIS XR during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized 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 AND PRECAUTIONS].
XARTEMIS XR contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limit, and often involve more than one acetaminophen-containing product [see WARNINGS AND PRECAUTIONS].
XARTEMIS XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets combine two analgesics, oxycodone hydrochloride 7.5 mg and acetaminophen 325 mg for oral administration.
Oxycodone hydrochloride, 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, is an opioid agonist which occurs as a white, odorless, crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine. The structural formula for oxycodone hydrochloride is as follows:
Acetaminophen, 4'-hydroxyacetanilide, is a white, odorless, crystalline powder, possessing a slightly bitter taste. The structural formula for acetaminophen is as follows:
XARTEMIS XR is an extended-release tablet for oral administration containing both immediate- and extended-release components. XARTEMIS XR is formulated to immediately release a portion of its oxycodone and acetaminophen doses. XARTEMIS XR is designed to swell in gastric fluid and gradually release the remainder of oxycodone and acetaminophen to the upper gastrointestinal (GI) tract.
XARTEMIS XR also contains the following inactive ingredients: polyethylene oxide (Polyox), microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, polyvinyl alcohol, magnesium stearate, titanium dioxide, polyethylene glycol, colloidal silicon dioxide, talc, pregelatinized starch, FD&C Blue #2 aluminum lake, citric acid anhydrous powder, and edentate disodium.
Last reviewed on RxList: 5/24/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Xartemis XR Information
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