Oxycodon / Naloxon Krugmann

Active Ingredient:: Naloxone Hydrochloride, Oxycodone Hydrochloride
Origin:: EU

Oxycodon / Naloxon Krugmann (Naloxone Hydrochloride, Oxycodone Hydrochloride)

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

Naloxone hydrochloride / Oxycodone hydrochloride, the active ingredient in Oxycodon / Naloxon Krugmann, is an opioid analgesic and opioid antagonist presented as a combination product 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 Oxycodon / Naloxon Krugmann as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

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

Manufacturer / TM Owner

Krugmann Gmbh (Germany)

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Indications & Clinical Uses

Oxycodone/naloxone is an oral opioid analgesic formulation that acts on the central nervous system to treat pain conditions.

Chronic cancer pain: provides long‑lasting relief while limiting opioid‑related constipation.
Post‑operative pain: controls moderate to severe pain after surgery.
Severe non‑cancer chronic pain: offers sustained analgesia for patients who require strong opioids.
Acute severe pain episodes: delivers rapid pain control when other treatments are insufficient.

How It Works

The combination pairs oxy‑acetyl‑acetate (oxycodone) with naloxone, a μ‑opioid receptor antagonist. Oxycodone activates μ‑receptors in the central nervous system, producing analgesia. Naloxone remains largely inactive when taken orally because of extensive first‑pass metabolism, but it blocks peripheral μ‑receptors in the gut, reducing opioid‑induced constipation and other gastrointestinal effects while preserving central analgesia.

Side Effects

Side effects are related to both the opioid component and the peripheral opioid antagonist.

Common Side Effects

Nausea and vomiting: mild to moderate gastrointestinal upset.
Constipation: reduced bowel motility, though less severe than with oxycodone alone.
Dizziness or light‑headedness: may occur during dose adjustments.
Drowsiness or fatigue: sedation common with opioid therapy.
Dry mouth: reduced salivation.

Serious or Rare Side Effects

Respiratory depression: slowed breathing, especially with high doses or concurrent depressants.
Severe hypotension: marked drop in blood pressure.
Allergic reactions: rash, itching, swelling, or anaphylaxis.
Hepatic impairment: elevated liver enzymes in susceptible individuals.
Opioid withdrawal symptoms: rare, may occur if naloxone effect becomes systemic.

Precautions & Warnings

When prescribing Oxycodon / Naloxon Krugmann, clinicians should consider patient‑specific factors and monitor for adverse events.

Assess pain severity and opioid tolerance: ensure appropriate indication before initiating therapy.
Evaluate gastrointestinal history: patients with severe constipation may benefit most.
Monitor for respiratory depression: especially in opioid‑naïve individuals or when combined with sedatives.
Adjust dose in hepatic or renal impairment: reduced clearance may increase exposure.
Avoid use in patients with known hypersensitivity to either component.
Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Oxycodone/naloxone can interact with several drug classes, altering efficacy or safety.

Major Interactions (Avoid)

Concurrent CNS depressants (e.g., benzodiazepines, barbiturates): heightened risk of respiratory depression and profound sedation.
MAO inhibitors: may precipitate severe hypertension or serotonin syndrome.

Moderate Interactions (Monitor Closely)

CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): increase oxycodone plasma levels.
CYP3A4 inducers (e.g., rifampicin, carbamazepine): reduce analgesic effect.
Anticholinergic agents: may exacerbate constipation despite naloxone component.
Diuretics: potential for additive hypotensive effect.
Serotonergic drugs: monitor for serotonin syndrome signs.

Frequently Asked Questions

Oxycodon / Naloxon Krugmann is a fixed‑dose combination of oxycodone and naloxone designed to treat moderate to severe pain while reducing opioid‑related constipation. It is commonly prescribed for chronic cancer pain, post‑operative pain and severe non‑cancer chronic pain when strong opioid therapy is required.

Oxycodone activates μ‑opioid receptors in the central nervous system to produce analgesia. Naloxone, when taken orally, is largely metabolised before reaching the brain but blocks peripheral μ‑receptors in the gastrointestinal tract, mitigating constipation and other gut‑related opioid side effects while preserving central pain relief.

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

Safety data are limited. Opioids can cross the placenta and may cause neonatal respiratory depression, while naloxone exposure through breast milk is minimal. The product should only be used during pregnancy or lactation if the potential benefit justifies the potential risk, and under close medical supervision.

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.

Compared with oxycodone alone, the combination adds naloxone to reduce opioid‑induced constipation and gastrointestinal side effects. Unlike pure antagonists, it maintains central analgesia because naloxone’s oral bioavailability is low. This balance can improve patient comfort and adherence relative to standard opioid monotherapy.

Store the tablets at ambient temperature, preferably below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and do not use it after the expiry date indicated on the packaging.

The medication is supplied as oral tablets that should be swallowed whole with water. It is usually taken every 12 hours, but the exact schedule is determined by the prescribing clinician based on individual patient needs.

The most serious risks include respiratory depression, severe hypotension, allergic reactions such as anaphylaxis, and, rarely, opioid withdrawal symptoms if systemic naloxone exposure occurs. Patients should be monitored closely, especially when initiating therapy or adjusting the dose.

Patients with known hypersensitivity to oxycodone, naloxone or any excipients, those with severe respiratory insufficiency, uncontrolled asthma, or paralytic ileus should avoid this product. It is also contraindicated in individuals taking MAO inhibitors or in acute intoxication with other central nervous system depressants.

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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