Oxycodone/Naloxone Stada Arzneimittel Ag (Naloxone, Oxycodone)

Oxycodone/Naloxone is indicated for moderate to severe pain where opioid treatment is required and constipation is a concern.

• Chronic non‑cancer pain: provides effective analgesia while mitigating opioid‑induced bowel dysfunction.
• Cancer‑related pain: delivers strong pain relief with reduced risk of constipation.
• Post‑operative pain: manages acute pain after surgery and helps maintain bowel regularity.
• Severe musculoskeletal pain: controls intense pain episodes while limiting gastrointestinal side effects.
• Palliative care pain: offers comfort in end‑of‑life settings with lower constipation risk.

• The combination works by pairing oxycodone, a μ‑opioid receptor agonist that produces analgesia, with naloxone, a peripheral opioid antagonist that blocks μ‑receptors in the gastrointestinal tract. Oral naloxone has limited systemic absorption, so it counteracts opioid‑induced constipation without diminishing central pain relief provided by oxycodone.

Adverse reactions may range from mild to serious and should be monitored during therapy.

Common Side Effects

• Nausea and vomiting
• Constipation (when naloxone effect is insufficient)
• Dizziness or light‑headedness
• Dry mouth
• Headache
• Fatigue

Serious or Rare Side Effects

• Respiratory depression
• Severe hypotension
• Acute withdrawal syndrome
• Hepatotoxicity
• Allergic reactions such as rash or angio‑edema
• Cardiac arrhythmias

When prescribing Oxycodone/Naloxone, clinicians should consider patient‑specific factors and follow safe use guidelines.

• Assess pain severity: confirm that opioid therapy is appropriate.
• Evaluate bowel function: monitor for signs of constipation or opioid‑induced bowel dysfunction.
• Review concomitant CNS depressants: adjust dosing if sedatives or alcohol are used.
• Check hepatic or renal impairment: dose may need adjustment.
• Pregnancy and lactation: use only if benefits outweigh risks.
• Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Oxycodone/Naloxone can interact with several drug classes; awareness helps prevent adverse events.

Major Interactions (Avoid)

• Other opioids: risk of additive respiratory depression.
• Benzodiazepines or barbiturates: heightened CNS depression and sedation.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): increase oxy‑dose exposure.

Moderate Interactions (Monitor Closely)

• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may alter oxycodone metabolism.
• Anticholinergic agents: may worsen constipation if naloxone effect is insufficient.
• Diuretics: can enhance hypotensive effects.
• MAO inhibitors: may increase risk of serotonin syndrome.
• Herbal supplements such as St St  St