Oxycodone/Naloxone Stada

Active Ingredient:: Naloxone, Oxycodone
Origin:: EU

Oxycodone/Naloxone Stada (Naloxone, Oxycodone)

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

Oxycodone, the active ingredient in Oxycodone/Naloxone Stada, is an opioid analgesic presented as a combination tablet for oral use. It treats moderate to severe pain in adult patients when an opioid is required. Naloxone, the second active ingredient, is an opioid antagonist included to reduce opioid‑induced constipation and bowel dysfunction.

GNH India supplies Oxycodone/Naloxone 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 Stada is used in the management of pain conditions that involve opioid pathways. It provides balanced analgesia while mitigating opioid‑related gastrointestinal effects.

Chronic cancer pain: improves pain control while reducing constipation risk.
Post‑operative pain: offers strong analgesia after major surgery with a lower incidence of bowel dysfunction.
Severe chronic non‑cancer pain: delivers long‑term relief for patients who need high‑potency opioids.

How It Works

The formulation combines oxycodone, a µ‑opioid receptor agonist that mimics endogenous opioids to inhibit pain signalling in the central nervous system, with naloxone, a peripheral µ‑opioid receptor antagonist that remains largely confined to the gastrointestinal tract, counteracting opioid‑induced reduction of gut motility without diminishing central analgesia.

Side Effects

Adverse reactions may occur with Oxycodone/Naloxone Stada and should be monitored during therapy.

Common Side Effects

Nausea: mild to moderate upset stomach.
Constipation: reduced bowel movements despite naloxone.
Dizziness: light‑headed sensation, especially on standing.
Somnolence: increased sleepiness or fatigue.
Dry mouth: reduced salivary flow.
Headache: mild to moderate cranial pain.

Serious or Rare Side Effects

Respiratory depression: slowed breathing that can be life‑threatening.
Severe hypotension: marked drop in blood pressure.
Hepatic impairment: elevated liver enzymes or liver dysfunction.
Allergic reactions: rash, itching, swelling, or anaphylaxis.
Opioid dependence or withdrawal: signs of physical dependence with abrupt discontinuation.

Precautions & Warnings

When prescribing Oxycodone/Naloxone Stada, clinicians should consider several safety aspects.

Assess pain severity: confirm that opioid therapy is appropriate for the patient.
Monitor for respiratory depression: especially during initiation and dose escalation.
Evaluate liver function: naloxone metabolism is hepatic; adjust if impaired.
Caution in the elderly: increased sensitivity to sedative and hypotensive effects.
Avoid concurrent CNS depressants: limit additive sedation or respiratory risk.
Store at ambient temperature: keep below 25°C in the original container, protected from moisture.

Avoid Interactions

Oxycodone/Naloxone Stada can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

Benzodiazepines: combined use can cause profound respiratory depression.
CNS depressants: alcohol, barbiturates, or other sedatives increase risk of sedation and respiratory compromise.
MAO inhibitors: may precipitate severe hypertension or serotonin syndrome.

Moderate Interactions (Monitor Closely)

CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): can raise oxycodone plasma levels.
CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce analgesic effect.
Diuretics: may enhance hypotensive response.
Anticholinergics: can worsen constipation despite naloxone's protective effect.

Frequently Asked Questions

Oxycodone/Naloxone Stada is indicated for the management of moderate to severe pain, including chronic cancer pain, post‑operative pain and severe chronic non‑cancer pain, where strong opioid therapy is required and the risk of opioid‑induced constipation is a concern.

Oxycodone activates µ‑opioid receptors in the central nervous system to block pain signals, while naloxone acts as a peripheral µ‑opioid antagonist that remains largely confined to the gastrointestinal tract, helping to preserve normal bowel motility and reduce constipation without diminishing central analgesia.

The dosage of Oxycodone/Naloxone Stada is individualized and must be determined by a qualified prescriber based on the patient’s pain severity, prior opioid exposure, renal and hepatic function, and overall clinical condition.

Both oxycodone and naloxone cross the placenta and can be excreted in breast milk. Use during pregnancy or lactation is only justified if the potential benefit outweighs the potential risk to the fetus or infant, and it should be decided by the treating physician.

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 provides comparable analgesic potency while reducing the incidence of opioid‑induced constipation and bowel dysfunction, offering a more balanced safety profile for patients who require long‑term opioid therapy.

Store the tablets at ambient temperature, below 25 °C, in the original packaging to protect from moisture and light. Keep out of reach of children and unauthorized personnel.

The product is supplied as oral tablets that should be swallowed whole with water. It is typically taken every 12 hours, but exact timing and frequency are determined by the prescribing clinician.

Serious risks include respiratory depression, severe hypotension, hepatic impairment, opioid dependence or withdrawal, and rare allergic reactions such as anaphylaxis. Immediate medical attention is required if any of these events occur.

Patients with known hypersensitivity to oxycodone, naloxone or any excipients, those with severe respiratory insufficiency, acute or severe asthma, paralytic ileus, or uncontrolled severe hepatic impairment should avoid using this medication.

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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