Oxycodonhydrochlorid/Naloxonhydrochlorid Stada

Active Ingredient:: Naloxone, Oxycodone
Origin:: EU

Oxycodonhydrochlorid/Naloxonhydrochlorid Stada (Naloxone, Oxycodone)

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

Naloxone, the active ingredient in Oxycodonhydrochlorid/Naloxonhydrochlorid Stada, is a combination opioid analgesic and opioid antagonist presented as a fixed‑dose combination for oral use. It is used to manage moderate to severe pain while reducing the risk of opioid‑induced respiratory depression in adult patients.

GNH India supplies Oxycodonhydrochlorid/Naloxonhydrochlorid Stada 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 a fixed‑dose combination that acts on the opioid pathway to provide analgesia while mitigating opioid‑related side effects.

Chronic moderate to severe pain: provides effective pain relief while reducing the incidence of opioid‑induced constipation.
Post‑operative pain: maintains analgesia after surgery with a lower risk of respiratory depression.
Cancer‑related pain: offers sustained pain control for patients requiring strong opioids, with built‑in opioid‑antagonist protection.

How It Works

The combination pairs oxycodone, a μ‑opioid receptor agonist that produces analgesia, with naloxone, a peripheral opioid receptor antagonist that remains largely inactive when taken orally but blocks opioid receptors in the gastrointestinal tract, thereby reducing opioid‑induced constipation and other peripheral effects while preserving central analgesia.

Side Effects

Adverse reactions may occur with the Oxycodone/naloxone combination. Monitoring and appropriate management are essential.

Common Side Effects

Nausea: mild to moderate stomach upset.
Constipation: reduced bowel motility, though less frequent than with oxycodone alone.
Dizziness: transient light‑headedness.
Headache: mild to moderate intensity.
Dry mouth: reduced salivation.
Fatigue: feeling of tiredness.

Serious or Rare Side Effects

Respiratory depression: slowed breathing, potentially life‑threatening.
Severe hypotension: marked drop in blood pressure.
Hepatotoxicity: liver enzyme elevations.
Allergic reactions: rash, itching, or anaphylaxis.
Seizures: rare neurologic events.
Withdrawal syndrome: signs of opioid withdrawal if naloxone effect predominates.

Precautions & Warnings

When prescribing Oxycodone/naloxone, clinicians should consider patient‑specific factors and follow safety guidelines.

Assess pain severity: ensure the combination is appropriate for moderate to severe pain.
Evaluate respiratory function: monitor patients with compromised breathing.
Review hepatic function: adjust use in patients with liver impairment.
Monitor for dependence: watch for signs of opioid misuse or addiction.
Educate on constipation: advise patients on diet, hydration, and bowel regimen.
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 careful management.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may reduce oxycodone analgesic effect.
Diuretics: can enhance hypotensive effects.
Anticholinergics: may worsen constipation despite naloxone component.

Frequently Asked Questions

Oxycodonhydrochlorid/Naloxonhydrochlorid Stada is a fixed‑dose combination of oxycodone and naloxone that provides strong analgesia for moderate to severe pain while reducing opioid‑related constipation and respiratory depression. It is commonly prescribed for chronic pain, post‑operative pain and cancer‑related pain in adult patients.

Naloxone is an opioid receptor antagonist that, when taken orally, acts mainly in the gastrointestinal tract. It blocks peripheral opioid receptors, limiting constipation and other gut‑related side effects without interfering with the central analgesic action of oxycodone, which activates μ‑opioid receptors in the brain and spinal cord.

The dose is individualized by the prescribing clinician based on the patient’s pain intensity, prior opioid exposure, renal and hepatic function, and overall clinical condition. The prescriber determines the appropriate strength and dosing schedule according to local guidelines and the patient’s response.

Both oxycodone and naloxone cross the placenta and may be present in breast milk. Use is generally discouraged unless the potential benefit justifies the potential risk to the fetus or infant. Clinicians should evaluate risks carefully and consider alternative therapies when possible.

To place an order, submit an enquiry on the product page at gnhindia.com specifying 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.

The addition of naloxone to oxycodone offers comparable analgesic efficacy while reducing opioid‑induced constipation and potentially lowering the risk of respiratory depression. Oxycodone alone provides pain relief but is associated with higher rates of gastrointestinal side effects and may require separate laxative therapy.

Store the tablets below 25 °C in their original container, protected from moisture and direct sunlight. Keep out of reach of children and do not use after the expiry date printed on the packaging.

The product is taken orally, usually with water. It may be administered with or without food, but consistent intake with respect to meals helps maintain stable drug levels. Patients should follow the dosing schedule prescribed by their healthcare professional.

The most serious risks include respiratory depression, severe hypotension, hepatotoxicity, allergic reactions such as anaphylaxis, and opioid withdrawal syndrome if naloxone effect predominates. Immediate medical attention is required if any of these symptoms occur.

Patients with known hypersensitivity to oxycodone, naloxone or any excipients, those with severe respiratory insufficiency, acute or severe asthma, paralytic ileus, or significant hepatic impairment should avoid this medication. It is also contraindicated in patients receiving opioid antagonists for addiction treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 10 Oct 2026

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

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