Oxycodon/Naloxon Krka

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

Oxycodon/Naloxon Krka (Naloxone Hydrochloride, Oxycodone Hydrochloride)

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

Naloxone Hydrochloride, the active ingredient in Oxycodon/Naloxon Krka, is an opioid antagonist presented as a combination formulation for oral use. It is used together with oxycodone hydrochloride to manage moderate to severe pain while reducing opioid‑induced constipation and the risk of misuse.

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

Manufacturer / TM Owner

Krka, D.D., Novo Mesto

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Indications & Clinical Uses

Oxycodon/Naloxon Krka combines an opioid agonist with an antagonist to provide analgesia while limiting abuse potential. It is indicated for:

Acute postoperative pain: provides rapid, strong pain relief after surgery.
Cancer‑related pain: helps control moderate to severe pain in oncology patients.
Chronic non‑cancer pain: offers long‑term management of severe musculoskeletal or neuropathic pain when other treatments are insufficient.

How It Works

The formulation pairs oxycodone, a μ‑opioid receptor agonist, with naloxone, a peripheral μ‑opioid receptor antagonist that is poorly bioavailable when taken orally. Oxycodone activates central opioid receptors to produce analgesia, while naloxone remains largely in the gut, blocking opioid receptors there and reducing opioid‑induced constipation and other gastrointestinal side effects without diminishing central pain control.

Side Effects

Common Side Effects

Nausea: mild to moderate stomach upset.
Constipation: reduced bowel motility, though less frequent than with oxycodone alone.
Dizziness: light‑headed feeling, especially when standing.
Headache: transient cranial discomfort.
Dry mouth: reduced salivation.
Somnolence: mild sleepiness.

Serious or Rare Side Effects

Respiratory depression: slowed breathing, potentially life‑threatening.
Severe hypotension: marked drop in blood pressure.
Hepatotoxicity: liver enzyme elevations or injury.
Allergic reactions: rash, itching, swelling, or anaphylaxis.
Opioid dependence or withdrawal: signs of physical dependence with prolonged use.

Precautions & Warnings

Before prescribing Oxycodon/Naloxon Krka, consider the following precautions:

Assess renal and hepatic function: dosage may need adjustment in impairment.
Evaluate history of respiratory disorders: risk of respiratory depression is higher.
Monitor for signs of opioid dependence: use caution in patients with substance‑use history.
Avoid concurrent CNS depressants: increased sedation and respiratory risk.
Pregnancy and lactation: use only if benefit outweighs risk.
Store below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Oxycodon/Naloxon Krka can interact with several drug classes. Careful review of a patient’s medication list is essential.

Major Interactions (Avoid)

Other opioids: additive respiratory depression and sedation.
Benzodiazepines or barbiturates: profound CNS depression.
MAO inhibitors: risk of severe serotonin syndrome.

Moderate Interactions (Monitor Closely)

CYP3A4 inhibitors (e.g., ketoconazole): increased oxycodone levels.
CYP3A4 inducers (e.g., rifampicin): reduced analgesic effect.
Anticholinergic agents: may worsen constipation.
Diuretics: can amplify hypotensive effects.

Frequently Asked Questions

Oxycodon/Naloxon Krka is a fixed‑dose combination of oxycodone and naloxone indicated for the management of moderate to severe pain, including acute postoperative pain, cancer‑related pain and chronic non‑cancer pain, while helping to reduce opioid‑induced constipation.

Naloxone is a peripheral μ‑opioid receptor antagonist with low oral bioavailability. When taken with oxycodone, it blocks opioid receptors in the gastrointestinal tract, limiting constipation and other gut‑related side effects without interfering with the central analgesic action of oxycodone.

The dosage is individualized by the prescribing clinician based on pain severity, patient tolerance, renal and hepatic function, and prior opioid exposure. The prescriber determines the appropriate strength and dosing schedule for each patient.

Use during pregnancy or lactation is only recommended when the potential benefit justifies the potential risk to the fetus or infant. Clinicians should evaluate maternal pain needs against possible adverse effects and consider alternative therapies when possible.

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‑agent opioids, the oxycodone‑naloxone combo offers comparable analgesia while reducing the incidence of opioid‑induced constipation. It provides a built‑in strategy to mitigate a common side effect, which can improve patient adherence and quality of life versus opioids without an antagonist.

Store the product below 25 °C in its original packaging, protecting it from moisture and direct sunlight. Ensure the container is tightly closed to maintain tablet integrity and potency throughout its shelf life.

The medication 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 prescribing clinician’s instructions regarding timing and frequency.

The most serious risks include respiratory depression, severe hypotension, hepatotoxicity, and the potential for opioid dependence or withdrawal. Immediate medical attention is required if signs of respiratory compromise, extreme drowsiness, or allergic reactions occur.

Patients with known hypersensitivity to oxycodone, naloxone or any excipients, those with severe respiratory insufficiency, uncontrolled asthma, or significant gastrointestinal obstruction should avoid this product. It is also contraindicated in individuals taking monoamine oxidase inhibitors.

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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