Product image of Oxicodona/Naloxona Stada (Naloxone, Oxycodone) supplied by GNH India

Oxicodona/Naloxona Stada

Active Ingredient:
Naloxone, Oxycodone
Origin:
EU

Oxicodona/Naloxona Stada (Naloxone, Oxycodone)

International sale not permitted. Listed for the domestic market and B2B only.

Naloxone, the active ingredient in Oxicodona/Naloxona Stada, is an opioid antagonist presented as a combination formulation for oral use. It is paired with oxycodone, an opioid analgesic, to manage moderate to severe pain while reducing abuse potential. GNH India supplies Oxicodona/Naloxona Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

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

Manufacturer / TM Owner

Laboratorio Stada, S.L.

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Indications & Clinical Uses

Oxicodona/Naloxona Stada combines an opioid analgesic with an antagonist to treat pain while deterring misuse. Indications include:

  • Acute pain: Provides rapid relief of moderate to severe pain following surgery or injury.
  • Chronic cancer pain: Maintains long‑term analgesia for patients with malignant disease.
  • Severe musculoskeletal pain: Controls persistent pain from conditions such as severe osteoarthritis or back pain.
  • Post‑operative pain: Manages pain after major surgical procedures.
  • Pain requiring opioid rotation: Offers an alternative when switching from other opioid regimens.
  • Break‑through pain: Addresses episodic spikes in pain for patients already on scheduled opioid therapy.

How It Works

  • The combination works by oxycodone activating mu‑opioid receptors in the central nervous system to produce analgesia, while naloxone, with low oral bioavailability, blocks these receptors if the formulation is tampered with or injected, thereby reducing the risk of opioid‑induced respiratory depression and abuse.

Side Effects

Side effects are reported across a range of frequencies and severities.

Common Side Effects

  • Nausea: Mild to moderate stomach upset.
  • Constipation: Reduced bowel movements.
  • Dizziness: Light‑headed sensation, especially when standing.
  • Sedation: Feeling of drowsiness or reduced alertness.
  • Dry mouth: Reduced salivation.
  • Headache: Mild to moderate head pain.

Serious or Rare Side Effects

  • Respiratory depression: Shallow or slowed breathing.
  • Severe hypotension: Marked drop in blood pressure.
  • Allergic reactions: Rash, itching, swelling, or anaphylaxis.
  • Hepatotoxicity: Liver enzyme elevations or injury.
  • Seizures: Uncontrolled convulsions.
  • Opioid dependence: Potential for misuse despite naloxone component.

Precautions & Warnings

When prescribing Oxicodona/Naloxona Stada, clinicians should consider several safety measures.

  • Assess pain severity: Confirm that opioid therapy is appropriate for the patient’s level of pain.
  • Monitor respiratory function: Observe for signs of slowed breathing, especially after dose initiation.
  • Evaluate liver function: Check hepatic enzymes in patients with known liver disease.
  • Review concomitant medications: Identify other central nervous system depressants.
  • Educate patients: Instruct on proper use, risks of misuse, and signs of overdose.
  • Store at ambient temperature: Keep below 25°C in the original packaging, protected from moisture.

Avoid Interactions

Oxicodona/Naloxona Stada may interact with other medicines, altering its safety or effectiveness.

Major Interactions (Avoid)

  • Benzodiazepines: Combined CNS depression can cause profound sedation and respiratory failure.
  • CNS depressants: Alcohol, barbiturates, or other sedatives increase risk of respiratory depression.
  • MAO inhibitors: May potentiate opioid effects and precipitate hypertensive crisis.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors: Ketoconazole, erythromycin, and similar agents can raise oxycodone levels.
  • CYP3A4 inducers: Rifampicin, carbamazepine may lower oxycodone concentrations, reducing analgesia.
  • Anticholinergics: May worsen constipation associated with opioid use.

Frequently Asked Questions

Oxicodona/Naloxona Stada is a fixed‑dose combination of oxy‑pain relief and naloxone designed to treat moderate to severe acute or chronic pain while providing an abuse‑deterrent mechanism that limits opioid‑related adverse effects when the product is misused.

Naloxone is an opioid antagonist with very low oral bioavailability; it remains largely inactive when the tablet is taken as prescribed but blocks mu‑opioid receptors if the formulation is crushed or injected, rapidly reversing opioid effects and reducing the risk of respiratory depression.

The specific dose and dosing schedule are determined by the prescribing clinician based on the patient’s pain intensity, prior opioid exposure, renal and hepatic function, and overall clinical condition. No universal dosing regimen is provided here.

Opioid analgesics, including oxycodone, are generally classified as Category C or D for pregnancy, indicating potential risk to the fetus, while naloxone’s safety data are limited. Breastfeeding mothers should consult a healthcare professional, as opioids can pass into breast milk and affect the infant.

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.

Compared with single‑component opioids, this combination adds naloxone to deter misuse and reduce the likelihood of severe respiratory depression if tampered with. It offers similar analgesic potency to oxycodone alone but includes an added safety layer absent in non‑antagonist formulations.

Store the tablets at ambient temperature, preferably below 25 °C, in the original container to protect from moisture and light. Keep out of reach of children and do not use if the packaging is damaged.

The medication is taken orally, usually with water, and may be administered with or without food according to the prescribing clinician’s guidance. Patients should follow the exact dosing instructions provided on the prescription label.

The most serious risks include respiratory depression, severe hypotension, opioid dependence, and rare allergic reactions such as anaphylaxis. Prompt medical attention is required if any signs of these conditions appear.

Individuals with known hypersensitivity to oxycodone, naloxone, or any excipients, as ​​​​   

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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International sale not permitted. Listed for the domestic market and B2B only.

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