Xtampza ER

Generic name: oxycodone

Drug class: Opioids (narcotic analgesics)

Dosage form: Extended-release capsules

Root of administration: Oral

Dose: 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg capsules; typically administered every 12 hours

Mechanism of action: Oxycodone is a semi-synthetic opioid that binds to opioid receptors in the central nervous system, altering the perception and response to pain.

Drug usage cases:

• Management of severe and persistent pain requiring daily, around-the-clock, long-term opioid treatment when alternative treatments are inadequate

Drug contraindications:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity (e.g., anaphylaxis) to oxycodone

Side effects:

• Constipation
• Nausea
• Somnolence
• Vomiting
• Tiredness
• Headache
• Dizziness
• Abdominal pain

Warnings:

• Risk of addiction, abuse, and misuse, which can lead to overdose and death
• Life-threatening respiratory depression, especially during initiation or following a dosage increase
• Accidental ingestion, particularly by children, can result in a fatal overdose
• Concomitant use with benzodiazepines or other central nervous system depressants may result in profound sedation, respiratory depression, coma, and death
• Risk of neonatal opioid withdrawal syndrome if used during pregnancy
• Interaction with cytochrome P450 3A4 inhibitors may increase oxycodone plasma concentrations, leading to increased or prolonged adverse effects

Use during pregnancy or breastfeeding: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. The safety of oxycodone during breastfeeding is not established; it is not recommended during treatment with Xtampza ER.