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Addition, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Cytochrome P450 3A4 Interaction

Addiction, Abuse, and Misuse

  • TROXYCA ER 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 TROXYCA ER, and monitor all patients regularly for the development of these behaviors and conditions [seeWARNINGS AND PRECAUTIONS (5.1)].
  • Consider prescribing naloxone for the emergency treatment of opioid overdose

Life-threatening Respiratory Depression

  • Serious, life-threatening, or fatal respiratory depression may occur with use of TROXYCA ER. Monitor for respiratory depression, especially during initiation of TROXYCA ER or following a dose increase. Instruct patients to swallow TROXYCA ER capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving TROXYCA ER can cause rapid release and absorption of a potentially fatal dose of oxycodone [see WARNINGS AND PRECAUTIONS (5.2)].
  • Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper.

Accidental Ingestion

  • Accidental ingestion of even one dose of TROXYCA ER, especially by children, can result in a fatal overdose of oxycodone [see WARNINGS AND PRECAUTIONS (5.2)].

Neonatal Opioid Withdrawal Syndrome

  • Prolonged use of TROXYCA ER 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 AND PRECAUTIONS (5.3)].

Cytochrome P450 3A4 Interaction

  • The concomitant use of TROXYCA ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentrations. Monitor patients receiving TROXYCA ER and any CYP3A4 inhibitor or inducer [seeWARNINGS AND PRECAUTIONS (5.4)DRUG INTERACTIONS (7)CLINICAL PHARMACOLOGY (12.3)].

FDA and Industry Communications

Index to FDA Drug Safety Information

Approved Risk Evaluation and Mitigation Strategies (REMS)

TROXYCA ER (Oxycodone/Natrexone) Capsule

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Updated April 2021