Product image of Oxycodon/Naloxon Al (Naloxone, Oxycodone) supplied by GNH India

Oxycodon/Naloxon Al

Active Ingredient:
Naloxone, Oxycodone
Origin:
EU

Oxycodon/Naloxon Al (Naloxone, Oxycodone)

Naloxone, the active ingredient in Oxycodon/Naloxon Al, is an opioid antagonist presented as a combination formulation for oral use. It is used together with oxycodone to manage moderate to severe pain while reducing the risk of opioid‑induced constipation and respiratory depression in adult patients. GNH India supplies Oxycodon/Naloxon Al as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

GNH India supplies Oxycodon/Naloxon Al as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Aliud Pharma Gmbh

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Indications & Clinical Uses

Oxycodon/Naloxon Al combines oxycodone and naloxone and acts on the opioid pathway:

  • Acute pain: provides rapid relief of moderate‑to‑strong pain following surgery or trauma.
  • Chronic cancer pain: maintains long‑term analgesia for patients with malignant disease.
  • Severe non‑cancer pain: offers sustained pain control when weaker opioids are insufficient.
  • Opioid‑induced constipation: the naloxone component counteracts opioid‑related bowel effects while preserving analgesia.
  • Break‑through pain episodes: allows supplemental dosing for sudden pain spikes.
  • Post‑operative recovery: facilitates early mobilization by controlling pain without excessive sedation.

How It Works

  • The combination works by delivering oxycodone, a μ‑opioid receptor agonist that produces analgesia, together with naloxone, a peripheral μ‑opioid receptor antagonist that limits opioid‑induced gastrointestinal effects. Naloxone has low oral bioavailability, so it acts mainly in the gut, while oxycodone is absorbed systemically to provide central pain relief.

Side Effects

Side‑effect profiles reflect both opioid agonist and antagonist actions.

Common Side Effects

  • Nausea and vomiting: mild to moderate gastrointestinal upset.
  • Constipation: reduced bowel motility despite naloxone’s partial protection.
  • Dizziness or light‑headedness: transient vestibular effects.
  • Drowsiness or somnolence: sedation common with opioid therapy.
  • Dry mouth: reduced salivary secretion.
  • Headache: tension‑type or migraine‑like pain.

Serious or Rare Side Effects

  • Respiratory depression: marked reduction in breathing rate.
  • Severe hypotension: sudden drop in blood pressure.
  • Allergic reactions: rash, pruritus, or anaphylaxis.
  • Opioid dependence or withdrawal: signs of physical dependence.
  • Hepatic impairment: elevated liver enzymes.
  • Urinary retention: difficulty initiating urination.

Precautions & Warnings

When prescribing Oxycodon/Naloxon Al, clinicians should consider several safety measures:

  • Assess renal and hepatic function: adjust use in patients with significant impairment.
  • Evaluate respiratory status: avoid in uncontrolled respiratory depression.
  • Review concomitant CNS depressants: increased sedation risk.
  • Monitor for signs of opioid dependence: educate patients on proper use.
  • Pregnancy and lactation: weigh benefits against potential fetal/neonatal risks.
  • Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Oxycodon/Naloxon Al may interact with a range of medicines; careful review is required:

Major Interactions (Avoid)

  • Concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may increase oxy‑c‑c‑c.
  • MAO‑inhibitors: risk of severe serotonin syndrome.
  • Central nervous system depressants (benzodiazepines, barbiturates): heightened respiratory depression.
  • Other opioid agonists: additive opioid effects and overdose risk.
  • Alcohol: potentiates sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, quinidine): may alter oxycodone metabolism.
  • Diuretics: can enhance hypotensive effects.
  • Anticholinergic agents: may worsen constipation.
  • Antihistamines: increase drowsiness.
  • Herbal supplements (St. St           ...

Frequently Asked Questions

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GNH India Pharmaceuticals Limited

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