Product image of Oxykodón/Naloxón Stada Arzneimittel (Naloxone, Oxycodone) supplied by GNH India

Oxykodón/Naloxón Stada Arzneimittel

Active Ingredient:
Naloxone, Oxycodone
Origin:
EU

Oxykodón/Naloxón Stada Arzneimittel (Naloxone, Oxycodone)

Naloxone, the active ingredient in Oxykodón/Naloxón Stada Arzneimittel, is an opioid antagonist presented as a combination formulation for oral use. It is used together with oxycodone to manage moderate to severe pain in adults when a balanced analgesic effect and opioid‑overdose protection are desired.

GNH India supplies Oxykodón/Naloxón Stada Arzneimittel as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Oxycodone/naloxone is indicated for pain management within the opioid analgesic pathway, providing relief while reducing abuse potential.

  • Chronic cancer pain: improves analgesia while lowering opioid‑induced constipation.
  • Severe postoperative pain: offers strong pain control with built‑in opioid antagonism.
  • Chronic non‑cancer pain requiring long‑term opioid therapy: maintains pain relief and mitigates bowel side effects.
  • Acute severe trauma pain: delivers rapid analgesia with reduced risk of respiratory depression.
  • Palliative care pain: ensures comfort while protecting against opioid‑related adverse events.

How It Works

  • The combination pairs oxycodone, a µ‑opioid receptor agonist that produces analgesia, with naloxone, a µ‑opioid receptor antagonist that is poorly absorbed orally. When taken together, oxycodone activates central opioid receptors for pain relief, while naloxone acts locally in the gastrointestinal tract to block opioid receptors, reducing constipation and other peripheral opioid effects without diminishing central analgesia.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: mild to moderate gastrointestinal upset.
  • Constipation: reduced bowel motility despite naloxone's protective effect.
  • Dizziness or light‑headedness: transient vestibular sensations.
  • Headache: mild cranial discomfort.
  • Dry mouth: decreased salivation.
  • Fatigue: general sense of tiredness.

Serious or Rare Side Effects

  • Respiratory depression: severe reduction in breathing rate.
  • Severe hypotension: marked drop in blood pressure.
  • Hepatotoxicity: liver enzyme elevations or injury.
  • Allergic reactions: rash, pruritus, or anaphylaxis.
  • Seizures: rare neurologic events.
  • Urinary retention: difficulty emptying the bladder.

Precautions & Warnings

When prescribing Oxykodón/Naloxón Stada Arzneimittel, clinicians should consider several safety aspects.

  • Assess renal and hepatic function: adjust therapy if impairment is present.
  • Monitor for signs of opioid dependence: watch for misuse behaviors.
  • Evaluate respiratory status: especially in opioid‑naïve patients.
  • Use caution in the elderly: increased sensitivity to sedative effects.
  • Avoid abrupt discontinuation: taper to prevent withdrawal.
  • Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Oxycodone/naloxone may interact with several drug classes, requiring vigilance.

Major Interactions (Avoid)

  • CNS depressants (e.g., benzodiazepines, barbiturates): heightened risk of respiratory depression.
  • MAO inhibitors: can precipitate severe hypertension or serotonin syndrome.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase oxycodone plasma levels.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine): may alter oxycodone metabolism.
  • Diuretics: can exacerbate hypotension.
  • Anticholinergic agents: increase risk of constipation despite naloxone.

Frequently Asked Questions

Oxykodón/Naloxón Stada Arzneimittel is a fixed‑dose combination of oxycodone and naloxone used to treat moderate to severe pain, particularly when long‑term opioid therapy is needed and there is a desire to reduce opioid‑related constipation and other peripheral side effects.

Naloxone is an opioid receptor antagonist that is poorly absorbed when taken orally. In the combination, it blocks µ‑opioid receptors in the gastrointestinal tract, preventing constipation and other peripheral opioid effects while allowing oxycodone to act centrally for pain relief.

The specific dose is determined by the prescribing clinician based on the patient’s pain severity, prior opioid exposure, renal and hepatic function, and overall clinical condition. Dosage adjustments are made individually and are not standardized in public literature.

Safety in pregnancy and lactation has not been fully established. The drug should only be used if the potential benefit justifies the potential risk to the fetus or infant, and it is prescribed under close medical supervision.

To place an order, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Unlike single‑component opioids, this combination adds naloxone to mitigate opioid‑induced constipation and some peripheral side effects. It offers comparable analgesic potency to oxycodone alone while providing a built‑in safety feature that many clinicians prefer for chronic therapy.

Store the product below 25 °C in its original packaging, protecting it from moisture and direct sunlight. Do not expose the tablets to excessive heat or humidity, and keep them out of reach of children.

The medication is taken orally, usually as a whole tablet, with water. It is typically administered every 12 hours, but the exact schedule should follow the prescribing clinician’s instructions.

Serious risks include respiratory depression, severe hypotension, hepatotoxicity, allergic reactions such as anaphylaxis, seizures, and urinary retention. Patients should be monitored closely for these events, especially during treatment initiation or dose changes.

Individuals with known hypersensitivity to oxycodone, naloxone or any excipients, those with severe respiratory insufficiency, uncontrolled narrow‑angle glaucoma, or significant hepatic impairment should avoid this medication unless specifically directed by a qualified healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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