Product image of Noldoxen (Naloxone Hydrochloride, Oxycodone Hydrochloride) supplied by GNH India

Noldoxen

Active Ingredient:
Naloxone Hydrochloride, Oxycodone Hydrochloride
Origin:
EU

Noldoxen (Naloxone Hydrochloride, Oxycodone Hydrochloride)

Naloxone Hydrochloride and Oxycodone Hydrochloride, the active ingredients in Noldoxen, are a combined opioid antagonist/agonist presented as an oral tablet for oral use. It is employed to reverse opioid overdose while providing analgesia in controlled clinical settings.

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

Manufacturer / TM Owner

Krka, D.D., Novo Mesto

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Indications & Clinical Uses

Noldoxen combines an opioid antagonist and agonist, acting on opioid pathways for acute overdose management and severe pain relief.

  • Acute opioid overdose: rapidly reverses respiratory depression while allowing controlled analgesia.
  • Severe postoperative pain: provides effective analgesia for moderate to severe pain.
  • Chronic cancer pain: used under strict supervision for long‑term pain control.

How It Works

  • Naloxone Hydrochloride competitively blocks mu‑opioid receptors, preventing opioid‑mediated effects, while Oxycodone Hydrochloride binds to the same receptors as an agonist, activating them to produce analgesia. The combined formulation allows simultaneous reversal of excess opioid activity and provision of controlled pain relief when administered orally.

Side Effects

Noldoxen may cause a range of adverse reactions related to both its naloxone and oxycodone components.

Common Side Effects

  • Nausea: feeling of sickness or urge to vomit.
  • Constipation: reduced bowel movements.
  • Dizziness: light‑headed sensation.
  • Drowsiness: increased sleepiness.
  • Sweating: excessive perspiration.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing.
  • Severe hypotension: marked drop in blood pressure.
  • Allergic reaction: rash, itching, swelling, or anaphylaxis.
  • Seizures: convulsive episodes.
  • Cardiac arrhythmia: irregular heart rhythm.

Precautions & Warnings

When prescribing Noldoxen, clinicians should consider several safety measures to minimize risk.

  • Assess opioid tolerance: confirm patient’s prior exposure to opioids before initiating therapy.
  • Monitor respiratory function: observe breathing rate and oxygen saturation, especially after the first dose.
  • Evaluate hepatic and renal function: adjust use in patients with liver or kidney impairment.
  • Avoid use in patients with known hypersensitivity to naloxone or oxycodone.
  • Educate patients on signs of overdose and dependence.
  • Store at ambient temperature: keep below 25°C in the original packaging, protected from moisture.

Avoid Interactions

Noldoxen can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Benzodiazepines: combined CNS depression may cause profound sedation and respiratory depression.
  • Alcohol: additive depressant effects increase risk of respiratory compromise.
  • Other opioids: additive opioid effects can lead to overdose.
  • MAO inhibitors: may potentiate opioid toxicity.
  • CNS depressants (e.g., barbiturates, antihistamines): heightened sedation and respiratory risk.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may increase oxycodone plasma levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce analgesic effect.
  • Antidepressants (e.g., SSRIs, SNRIs): monitor for serotonin syndrome.
  • Diuretics: may affect blood pressure when combined with hypotensive effects.
  • Anticholinergic agents: may exacerbate constipation.

Frequently Asked Questions

Noldoxen is a prescription oral medication that combines naloxone and oxycodone. It is used in clinical settings to reverse acute opioid overdose while simultaneously providing analgesia for severe pain, such as postoperative or cancer‑related pain, under strict medical supervision.

Naloxone Hydrochloride acts as a competitive antagonist at mu‑opioid receptors. By binding to these receptors without activating them, it displaces opioid molecules and rapidly reverses opioid‑induced effects such as respiratory depression, allowing the body to recover normal breathing function.

Oxycodone Hydrochloride is a mu‑opioid receptor agonist. When it binds to these receptors, it triggers a cascade that reduces the perception of pain and produces a sense of relief, making it effective for managing moderate to severe pain when used according to a prescriber's instructions.

The dose of Noldoxen is individualized by the prescribing clinician based on the patient’s medical condition, opioid tolerance, age, weight, renal and hepatic function, and the severity of pain or overdose situation. No standard dosing regimen is provided publicly.

Safety data for Noldoxen in pregnancy and lactation are limited. Both naloxone and oxycodone cross the placenta and may be excreted in breast milk. Clinicians should weigh potential benefits against risks and consider alternative therapies when treating pregnant or nursing patients.

To request Noldoxen, 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.

Unlike single‑component opioids, Noldoxen pairs an opioid agonist (oxycodone) with an antagonist (naloxone) in the same tablet. This design reduces the risk of accidental overdose by providing built‑in reversal capability, but it also requires careful dosing and monitoring compared with standard opioid analgesics.

Noldoxen should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight and heat sources to maintain potency and stability throughout its shelf life.

Noldoxen is taken orally, typically as a whole tablet. It should be swallowed with water and not chewed or crushed unless specifically directed by a healthcare professional. Administration should follow the prescriber’s instructions regarding timing relative to other medications.

The most serious risks include respiratory depression, severe hypotension, allergic reactions such as anaphylaxis, seizures, and cardiac arrhythmias. Patients should be monitored closely for signs of these events, especially during the initial dosing period or when combined with other CNS depressants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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