Oxycodone/Naloxone Krka

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

Oxycodone/Naloxone Krka (Naloxone Hydrochloride, Oxycodone Hydrochloride)

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

Oxycodone, the active ingredient in Oxycodone/Naloxone Krka, is a 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 mitigate opioid‑induced constipation.

GNH India supplies Oxycodone/Naloxone 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

Oxycodone/Naloxone Krka is used in the management of pain conditions that involve opioid‑mediated pathways.

Chronic non‑cancer pain: provides analgesia while reducing constipation risk.
Cancer‑related pain: offers strong opioid relief with built‑in bowel‑function protection.
Post‑operative pain: delivers effective postoperative analgesia with a lower incidence of opioid‑induced bowel dysfunction.

How It Works

The combination works by binding to μ‑opioid receptors: oxycodone acts as an agonist to produce analgesia, while naloxone remains largely inactive when taken orally but antagonises peripheral μ‑receptors in the gastrointestinal tract, reducing opioid‑induced constipation without compromising central pain relief.

Side Effects

Adverse reactions may occur with any opioid‑containing product.

Common Side Effects

Nausea: mild to moderate stomach upset.
Constipation: reduced bowel motility, though less frequent than with oxycodone alone.
Dizziness: light‑headed sensation, especially on standing.
Somnolence: increased sleepiness or fatigue.
Dry mouth: reduced salivation.
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.
Allergic reactions: rash, itching, swelling, or anaphylaxis.
Opioid dependence or withdrawal: signs of addiction or abrupt cessation symptoms.
Hepatic impairment: elevated liver enzymes or liver injury.
Seizures: rare neurologic events.

Precautions & Warnings

When prescribing Oxycodone/Naloxone Krka, clinicians should consider several safety measures.

Assess pain severity: confirm that opioid therapy is appropriate.
Monitor for respiratory depression: especially during initiation or dose changes.
Evaluate bowel function: ensure the naloxone component is effective.
Review concomitant CNS depressants: avoid additive sedation.
Adjust for renal/hepatic impairment: dose may need modification.
Store at ambient temperature: keep below 25°C in the original container, protected from moisture.

Avoid Interactions

Oxycodone/Naloxone Krka can interact with several medication classes.

Major Interactions (Avoid)

Benzodiazepines: combined use can cause profound respiratory depression.
CNS depressants: additive sedation and lowered consciousness.
MAO inhibitors: risk of severe hypertension or serotonin syndrome.

Moderate Interactions (Monitor Closely)

Antidepressants (SSRIs/SNRIs): may increase serotonin levels.
Anticholinergics: can exacerbate constipation.
CYP3A4 inhibitors (e.g., ketoconazole): may raise oxycodone plasma concentrations.

Frequently Asked Questions

Oxycodone/Naloxone Krka is indicated for the management of moderate to severe pain, including chronic non‑cancer pain, cancer‑related pain, and postoperative pain, where an opioid is required and there is a need to reduce opioid‑induced constipation.

Oxycodone is a μ‑opioid receptor agonist that provides central analgesia by mimicking endogenous opioids, reducing the perception of pain. In the combination, it delivers the primary pain‑relieving effect while naloxone limits peripheral opioid effects on the gut.

The dosage is individualized by the prescribing clinician based on the patient’s pain severity, prior opioid exposure, and overall health status. The prescriber determines the appropriate strength and dosing schedule.

Both oxycodone and naloxone cross the placenta and can be present in breast milk. Use is generally discouraged unless the potential benefit justifies the risk, and it should only be prescribed by a specialist familiar with maternal‑fetal considerations.

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, an opioid antagonist that remains largely inactive systemically but blocks peripheral opioid receptors in the gastrointestinal tract, thereby reducing the incidence of constipation commonly seen with oxycodone‑only therapy while maintaining analgesic efficacy.

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 taken orally, usually as whole tablets, with or without food as directed by the prescriber. Swallow the tablet whole; do not crush or chew, as this may affect the naloxone release profile.

The most critical risks include respiratory depression, severe hypotension, opioid dependence or withdrawal, and rare allergic reactions such as anaphylaxis. 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, and individuals taking prohibited CNS depressants should avoid this medication unless closely supervised.

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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