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oxycodone hydrochloride and acetaminophen
Overview
What is Xartemis?
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 edetate disodium.
What does Xartemis look like?
What are the available doses of Xartemis?
Extended-release tablets (oxycodone hydrochloride/acetaminophen): 7.5 mg/325 mg (
)
What should I talk to my health care provider before I take Xartemis?
How should I use Xartemis?
XARTEMIS XR is indicated for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses
, reserve XARTEMIS XR for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
XARTEMIS XR is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration.
XARTEMIS XR is given orally. Instruct patients to swallow XARTEMIS XR tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in mouth
. Do not break, chew, crush, cut, dissolve or split the tablets. Breaking, chewing, crushing, cutting, dissolving or splitting XARTEMIS XR tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death
.
The total daily dose of acetaminophen from all drug products should not exceed 4,000 milligrams.
What interacts with Xartemis?
Sorry No Records found
What are the warnings of Xartemis?
Sorry No Records found
What are the precautions of Xartemis?
Sorry No Records found
What are the side effects of Xartemis?
Sorry No records found
What should I look out for while using Xartemis?
XARTEMIS XR tablets are contraindicated in patients with
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
What might happen if I take too much Xartemis?
Clinical Presentation
Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
Oxycodone
Acute overdosage with XARTEMIS XR is often characterized by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, sometimes, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations
.
Acetaminophen
In acetaminophen overdosage, dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Treatment of Overdose
A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, assisted ventilation, and other supportive measures should be employed as indicated.
Oxycodone
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists naloxone or nalmefene are specific antidotes to respiratory depression resulting from opioid overdose.
For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in XARTEMIS XR, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
Acetaminophen
Gastric decontamination with activated charcoal should be administered just prior to N‑acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.
How should I store and handle Xartemis?
XARTEMIS XR (oxycodone hydrochloride and acetaminophen) extended-release tablets are oval shaped tablets with a blue coating, debossed with “M” in a box over “115” on one side of the tablet. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen and is packaged in bottles and blister packs.Bottles of 60 NDC 43063-531-60Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].XARTEMIS XR (oxycodone hydrochloride and acetaminophen) extended-release tablets are oval shaped tablets with a blue coating, debossed with “M” in a box over “115” on one side of the tablet. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen and is packaged in bottles and blister packs.Bottles of 60 NDC 43063-531-60Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].XARTEMIS XR (oxycodone hydrochloride and acetaminophen) extended-release tablets are oval shaped tablets with a blue coating, debossed with “M” in a box over “115” on one side of the tablet. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen and is packaged in bottles and blister packs.Bottles of 60 NDC 43063-531-60Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
Acetaminophen is a non-opioid, non-salicylate analgesic, and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.
Non-Clinical Toxicology
XARTEMIS XR tablets are contraindicated in patients withWARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor, as compared to 0.7% reported to occur with labetalol hydrochloride alone. The contribution of each of the treatments to this adverse reaction is unknown, but the possibility of a drug interaction cannot be excluded.
Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses greater than the normal anti-asthmatic dose of beta-agonist bronchodilator drugs may be required.
Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride. Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.
Synergism has been shown between halothane anesthesia and intravenously administered labetalol hydrochloride. During controlled hypotensive anesthesia using labetalol hydrochloride in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. The anesthesiologist should be informed when a patient is receiving labetalol hydrochloride.
Labetalol hydrochloride blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effect. If labetalol hydrochloride is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.
Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
XARTEMIS XR contains oxycodone, a Schedule II controlled substance. As an opioid, XARTEMIS XR exposes users to the risks of addiction, abuse, and misuse .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed XARTEMIS XR. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing XARTEMIS XR, and monitor all patients receiving XARTEMIS XR for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as XARTEMIS XR, but use in such patients necessitates intensive counseling about the risks and proper use of XARTEMIS XR along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing XARTEMIS XR. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity . 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.
Abuse or misuse of XARTEMIS XR by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxycodone and can result in overdose and death .
The following serious adverse reactions are described, or described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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