Life-Threatening Respiratory Depression

ROXICODONE may cause serious, life-threatening, or deadly respiratory depression. Keep an eye out for respiratory depression, especially when starting ROXICODONE or increasing the dose.

Consumption by Accident

Accidental ROXICODONE ingestion, particularly by youngsters, can result in a lethal ROXICODONE overdose.

Syndrome of Neonatal Opioid Withdrawal

Prolonged use of ROXICODONE during pregnancy can result in newborn opioid withdrawal syndrome, which can be fatal if not diagnosed and treated promptly, and needs therapy according to neonatology-specific procedures. If prolonged opioid use is necessary in a pregnant woman, inform her about the danger of neonatal opioid withdrawal syndrome and ensure that proper therapy is available.

Interaction with Cytochrome P450 3A4

Concurrent usage of ROXICODONE and all cytochrome P450 3A4 inhibitors may result in an increase in plasma oxycodone concentrations, which may exacerbate or prolong unpleasant responses and may result in potentially deadly respiratory depression. Additionally, stopping a concurrently utilized cytochrome P450 3A4 inducer may result in a rise in the plasma levels of oxycodone. Patients receiving ROXICODONE and any CYP3A4 inhibitor or inducer should be closely monitored.

Consequences of Concurrent Use with Benzodiazepines or Other Central Nervous System Depressants

Concurrent use of opioids with benzodiazepines or other CNS depressants, such as alcohol, may result in extreme drowsiness, respiratory depression, coma, or death.

Concurrent administration of ROXICODONE with benzodiazepines or other CNS depressants should be reserved for individuals who do not respond to alternate therapeutic alternatives.
Keep dosages and durations to a minimum.
Maintain an eye out for signs and symptoms of respiratory depression and sedation in patients.