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

Naldoxxa

Active Ingredient:
Naloxone Hydrochloride, Oxycodone Hydrochloride
Origin:
EU

Naldoxxa (Naloxone Hydrochloride, Oxycodone Hydrochloride)

Naloxone Hydrochloride, the active ingredient in Naldoxxa, is an opioid antagonist presented as an oral formulation for oral use. It reverses opioid overdose effects and, when combined with oxycodone, contributes to pain management in patients requiring moderate to severe analgesia.

GNH India supplies Naldoxxa 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

Naldoxxa acts on opioid pathways to provide both analgesia and overdose reversal.

  • Moderate to severe pain: delivers oxycodone‑mediated analgesia for patients needing strong pain control.
  • Opioid overdose reversal: naloxone component rapidly displaces opioids at receptors to restore normal respiration.
  • Post‑operative pain management: used when balanced analgesia and safety monitoring are required.

How It Works

  • Naloxone Hydrochloride competitively blocks mu, kappa and delta opioid receptors, displacing opioid agonists and reversing their effects. Oxycodone Hydrochloride binds as a mu‑opioid receptor agonist, activating intracellular pathways that inhibit nociceptive transmission, producing analgesia. The combined formulation allows simultaneous provision of analgesic effect and the capacity for rapid reversal if excessive opioid activity occurs.

Side Effects

Adverse reactions may vary depending on the relative contribution of each component.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Constipation: reduced bowel motility typical of opioid therapy.
  • Dizziness: transient light‑headedness.
  • Headache: mild cranial discomfort.

Serious or Rare Side Effects

  • Respiratory depression: severe reduction in breathing, especially if oxycodone dose is high.
  • Severe hypotension: marked drop in blood pressure.
  • Seizures: rare neurologic events.
  • Allergic reactions: rash, itching, or anaphylaxis.
  • Cardiac arrhythmia: irregular heart rhythm.

Precautions & Warnings

Careful assessment and monitoring are essential when using a combined opioid antagonist/analgesic.

  • Assess opioid tolerance: ensure patient has appropriate prior exposure.
  • Monitor respiratory status: watch for signs of depression or improvement.
  • Avoid use in severe hepatic impairment: metabolism may be altered.
  • Use caution during pregnancy: potential fetal risk, discuss with obstetrician.
  • Avoid concomitant CNS depressants: increased sedation risk.
  • Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Naldoxxa may interact with several medication classes, requiring vigilance.

Major Interactions (Avoid)

  • Other opioid antagonists: may negate analgesic effect of oxycodone.
  • MAO inhibitors: risk of hypertensive crisis when combined.
  • CNS depressants (e.g., barbiturates): additive respiratory depression.

Moderate Interactions (Monitor Closely)

  • Benzodiazepines: enhanced sedation and dizziness.
  • Alcohol: increased central nervous system depression.
  • CYP3A4 inhibitors (e.g., ketoconazole): may raise oxycodone plasma levels.

Frequently Asked Questions

Naldoxxa is a prescription oral medication that combines naloxone and oxycodone. It is used to manage moderate to severe pain while also providing the ability to reverse opioid overdose if excessive opioid activity occurs.

Naloxone acts as a competitive antagonist at mu, kappa and delta opioid receptors. By binding to these receptors without activating them, it displaces opioid agonists and rapidly reverses their effects, restoring normal breathing and consciousness in an overdose situation.

The specific dose of Naldoxxa is determined by the prescribing clinician based on the patient’s pain level, opioid tolerance, and clinical condition. Dosage adjustments are made individually and should follow the prescriber’s instructions.

Safety of Naldoxxa in pregnancy or while breastfeeding has not been fully established. The potential risks and benefits should be evaluated by the healthcare provider, and alternative therapies may be considered when possible.

To order Naldoxxa, 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.

Unlike single‑component opioids, Naldoxxa pairs an analgesic (oxycodone) with an antagonist (naloxone), offering built‑in safety for overdose reversal. This dual action can be advantageous in settings where rapid reversal may be needed, though it may not be suitable for patients who require pure opioid analgesia without antagonist activity.

Naldoxxa should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture and direct sunlight to maintain stability.

Naldoxxa is taken orally as directed by the prescriber. The tablet should be swallowed whole with water and not chewed or crushed unless specifically instructed.

The most serious risks include respiratory depression from the oxycodone component, severe hypotension, seizures, and rare allergic reactions such as anaphylaxis. Immediate medical attention is required if any of these occur.

Patients with known hypersensitivity to naloxone, oxycodone, or any excipients, those with severe hepatic impairment, or individuals taking MAO inhibitors should avoid Naldoxxa unless a specialist determines it is appropriate.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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International shipment of narcotics not permitted

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