Xartemis XR
Generic name:oxycodone hydrochloride and acetaminophen
Dosage form: tablet, coated
Drug class:Narcotic analgesic combinations
Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Clinical Studies
- Drug Interactions
- Use In Specific Populations
- Drug Abuse and Dependence
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
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
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 and conditions [see Warnings and Precautions (5.1)].
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 (5.2)].
Accidental Ingestion
Accidental ingestion of Xartemis XR, especi
