Brixadi

Potential risk for opioid overdose; strongly consider prescribing naloxone when initiating and renewing therapy. Consider prescribing naloxone if the patient has household members (eg, children) or other close contacts at risk of accidental ingestion or overdose. Not for IV, IM, or intradermal inj; risk of serious harm or death. Evaluate and treat if serious inj site reactions develop. Abuse potential (monitor). Risk of life-threatening respiratory and CNS depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Adrenal insufficiency. Risk of QT prolongation (esp. in those with hypokalemia, bradycardia, recent conversion from atrial fibrillation, CHF, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, severe hypomagnesemia). Obtain LFTs prior to initiation and during treatment; evaluate if hepatic event is suspected. Prescribe a non-opioid analgesic for managing acute pain; may use opioid therapy under physician supervision. Avoid in opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. Unintentional pediatric exposure. Acute alcoholism. Drug abusers. Latex allergy. Reevaluate periodically. Avoid abrupt cessation. Moderate to severe hepatic impairment: not recommended. Elderly. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: monitor infants.