Oxycodon-Hcl/Naloxon-Hcl Al

Active Ingredient:: Naloxone, Oxycodone
Origin:: EU

Oxycodon-Hcl/Naloxon-Hcl Al (Naloxone, Oxycodone)

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

Naloxone, the active ingredient in Oxycodon-Hcl/Naloxon-Hcl Al, is a combination opioid analgesic and opioid antagonist presented as a solid dosage form for oral use. It is used to manage moderate to severe pain while reducing the risk of opioid‑induced constipation and respiratory depression in adult patients. GNH India supplies Oxycodon-Hcl/Naloxon-Hcl Al as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

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

Manufacturer / TM Owner

Aliud Pharma Gmbh

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Indications & Clinical Uses

Naloxone/Oxycodone is a combination product that provides analgesia while mitigating opioid‑related side effects.

Acute postoperative pain: delivers effective pain relief while reducing opioid‑induced respiratory depression.
Cancer‑related chronic pain: provides sustained analgesia for patients with breakthrough pain.
Severe traumatic injury pain: offers rapid onset of strong analgesia with a built‑in safety mechanism.
Opioid rotation or tapering: assists in transitioning patients to lower‑dose opioid regimens with reduced risk of withdrawal.
Palliative care: supports comfort management in end‑of‑life settings where high‑potency analgesia is required.

How It Works

The product combines oxycodone, a μ‑opioid receptor agonist that produces analgesia by inhibiting pain signal transmission in the central nervous system, with naloxone, a peripheral opioid antagonist that blocks μ‑receptor activity in the gastrointestinal tract and limits central respiratory depression when the formulation is abused or taken intravenously. This dual action provides strong pain control while reducing common opioid‑related adverse effects.

Side Effects

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

Common Side Effects

Nausea: mild to moderate upset stomach.
Constipation: reduced bowel motility.
Dizziness: transient light‑headedness.
Sedation: feeling of sleepiness.
Dry mouth: reduced salivation.
Headache: mild cranial discomfort.

Serious or Rare Side Effects

Respiratory depression: slowed breathing, especially with high doses.
Severe hypotension: marked drop in blood pressure.
Hepatotoxicity: liver enzyme elevations.
Allergic reactions: rash, itching, or swelling.
Seizures: rare convulsive episodes.
Opioid dependence: risk of misuse with prolonged therapy.

Precautions & Warnings

When prescribing Oxycodon-Hcl/Naloxon-Hcl Al, clinicians should consider several safety measures.

Assess pain severity: ensure the combination is appropriate for the intensity of pain.
Review opioid history: evaluate prior opioid exposure and tolerance.
Monitor for respiratory depression: especially during initiation or dose changes.
Caution in hepatic impairment: adjust use if liver function is compromised.
Avoid in patients with known hypersensitivity to either component.
Store below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Oxycodon-Hcl/Naloxon-Hcl Al may interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

Benzodiazepines: additive central nervous system depression can increase risk of respiratory compromise.
MAO inhibitors: may precipitate severe hypertension or serotonin syndrome.
CNS depressants: combined effect may lead to profound sedation.

Moderate Interactions (Monitor Closely)

CYP3A4 inhibitors (e.g., ketoconazole): may raise oxycodone plasma levels.
CYP3A4 inducers (e.g., rifampicin): may reduce analgesic efficacy.
Anticholinergic agents: can exacerbate constipation.
Diuretics: may enhance hypotensive effects.
Serotonergic drugs: potential for serotonin syndrome, especially with high opioid doses.

Frequently Asked Questions

Oxycodon-Hcl/Naloxon-Hcl Al is a fixed‑dose combination of oxy‑opioid and naloxone designed to treat moderate to severe pain, such as postoperative, cancer‑related or trauma‑induced pain, while helping to limit opioid‑related constipation and respiratory depression.

Naloxone is an opioid antagonist that blocks μ‑receptor activity primarily in the gastrointestinal tract and, when the tablet is misused intravenously, in the central nervous system. This limits constipation and reduces the risk of severe respiratory depression without compromising the analgesic effect of oxycodone taken as prescribed.

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. Dosage adjustments are made individually and should follow local prescribing guidelines.

Both oxycodone and naloxone cross the placenta and are excreted in breast milk. Use during pregnancy or lactation is only justified when the potential benefit outweighs the risk to the fetus or infant, and it should be prescribed by a specialist familiar with maternal‑fetal medicine.

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 combination adds naloxone to standard oxycodone, which helps reduce opioid‑induced constipation and lowers the risk of respiratory depression if the tablet is abused intravenously. Efficacy for pain relief is comparable, but the safety profile is improved for patients at risk of opioid‑related adverse effects.

Store the tablets below 25 °C in their original packaging, protected from moisture, heat and direct sunlight. Do not expose the product to excessive humidity or temperatures above the recommended range to maintain potency.

The medication is supplied as oral tablets that should be swallowed whole with water. It is typically taken at regular intervals as prescribed, and should not be crushed, chewed, or dissolved, to preserve the intended release characteristics of both active ingredients.

Serious risks include respiratory depression, severe hypotension, hepatotoxicity, allergic reactions and the potential for opioid dependence. Patients should be monitored closely for signs of respiratory compromise, especially during dose initiation or escalation.

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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