Oxycodon-Hcl/Naloxon-Hcl Beta (Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur.)

Oxycodone/Naloxone is used primarily for pain management within the opioid pathway.

• Chronic non‑cancer pain: provides sustained analgesia while reducing opioid‑induced constipation.
• Cancer‑related pain: delivers strong opioid relief for breakthrough and background pain.
• Post‑operative pain: offers effective short‑term analgesia after surgical procedures.
• Acute severe pain: rapidly controls intense pain episodes such as trauma or renal colic.
• Palliative care: improves comfort in end‑of‑life settings by managing severe pain.
• Opioid rotation : facilitates switch to a different opioid regimen with lower gastro‑intestinal side‑effects.

• Oxycodone binds to µ‑opioid receptors in the central nervous system, producing analgesia, sedation and respiratory depression. Naloxone has low oral bioavailability but, when present in the gastrointestinal tract, it antagonises peripheral µ‑receptors, counteracting opioid‑induced constipation without affecting central analgesia. The fixed‑dose combination therefore provides pain relief while limiting one of the most common opioid side effects.

Side effects are reported across a range of severities.

Common Side Effects

• Nausea and vomiting: mild to moderate gastrointestinal upset.
• Constipation: reduced bowel motility despite naloxone presence.
• Dizziness or light‑headedness: transient vestibular effects.
• Somnolence: increased sleepiness or fatigue.
• Dry mouth: reduced salivary flow.
• Pruritus: mild skin itching.

Serious or Rare Side Effects

• Respiratory depression: significant reduction in breathing rate.
• Severe hypotension: marked drop in blood pressure.
• Allergic reactions: rash, urticaria, or anaphylaxis.
• Opioid dependence or withdrawal: signs of physical dependence.
• Hepatic impairment: elevated liver enzymes.
• Seizures: rare neurologic events.

When prescribing Oxycodon‑Hcl/Naloxon‑Hcl Beta, clinicians should consider several safety measures.

• Assess pain severity: confirm that opioid therapy is appropriate.
• Review medical history: identify respiratory, hepatic or renal conditions.
• Monitor for dependence: watch for signs of misuse or addiction.
• Avoid abrupt discontinuation: taper dose to prevent withdrawal.
• Concomitant CNS depressants: use with caution alongside benzodiazepines or alcohol.
• Store at ambient temperature: keep in the original packaging, protect from moisture and light.

• Oxycodon‑HCl & Naloxone‑HCl combination may inter act with several medications.
• Major Interactions (Avoid):
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• - M ​  ​   ​  ​  ​ ​ ​ ​ ​  ​
• - O ​  
• - S 
• - T 
• Moderate Moderate ... 
• - C 
• - D 
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