Oxycodone/Naloxone Ratiopharm (Oxycodone Hydrochloride, Naloxone Hydrochloride Dihydrate)

Oxycodone/Naloxone combines a potent opioid agonist with an opioid antagonist to provide analgesia while reducing opioid‑induced constipation.

• Chronic cancer pain: improves pain control in patients with persistent malignant pain.
• Post‑operative pain: provides short‑term relief after major surgery.
• Severe non‑cancer chronic pain: offers analgesia when weaker opioids are ineffective.
• Opioid‑induced bowel dysfunction: mitigates constipation associated with chronic opioid therapy.
• Palliative care: supports comfort in end‑of‑life situations.

• Oxycodone binds to µ‑opioid receptors in the central nervous system, producing analgesia, while naloxone has low oral bioavailability and acts locally in the gut to block µ‑receptor mediated effects that cause constipation, thereby preserving bowel function without diminishing systemic pain relief.

Oxycodone/Naloxone may produce a range of adverse reactions, most of which are dose‑dependent and related to its opioid activity.

Common Side Effects

• Nausea and vomiting
• Constipation (less frequent than with oxycodone alone)
• Dizziness
• Drowsiness
• Dry mouth
• Headache

Serious or Rare Side Effects

• Respiratory depression
• Severe hypotension
• Acute adrenal dysfunction
• Allergic reactions such as rash or anaphylaxis
• Opioid dependence or withdrawal syndrome
• QT‑interval prolongation in susceptible patients

When prescribing Oxycodone/Naloxone, clinicians should consider several safety aspects.

• Assess patient history: evaluate risk factors for respiratory depression and opioid misuse.
• Monitor renal and hepatic function: dose adjustments may be required in impairment.
• Avoid concurrent CNS depressants: increased sedation risk.
• Educate on constipation management: despite naloxone, bowel regimen may be needed.
• Pregnancy: classify "."
• Store at below 25°C: keep in the original pack and protect from moisture.

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