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 / Oxycodone Hydrochloride, the active ingredient in Noldoxen, is a combination opioid analgesic and opioid antagonist presented as an oral tablet for oral use. It provides pain relief for moderate to severe chronic pain while the naloxone component helps reduce opioid‑induced constipation and lowers abuse potential. The formulation is intended for prescription use under medical supervision and is classified as a Schedule II controlled substance in the EU.

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 agonist and an antagonist to address pain pathways and opioid‑related gastrointestinal effects.

  • Moderate to severe chronic pain: provides effective analgesia while limiting constipation.
  • Acute severe pain: delivers rapid pain relief for short‑term management.
  • Opioid‑induced constipation: naloxone component counteracts constipation without reducing analgesic effect.
  • Cancer‑related pain: offers controlled pain management with reduced risk of opioid‑induced bowel dysfunction.

How It Works

  • Oxycodone binds to mu‑opioid receptors in the central nervous system, activating G‑protein pathways that inhibit nociceptive neurotransmission and produce analgesia. Naloxone, when administered orally, has limited systemic absorption but antagonizes opioid receptors in the gastrointestinal tract, blocking the constipating effects of oxycodone and decreasing the potential for abuse by precipitating withdrawal if the formulation is tampered with.

Side Effects

Noldoxen may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: feeling of sickness or urge to vomit.
  • Dizziness: light‑headed sensation or loss of balance.
  • Headache: mild to moderate head pain.
  • Dry mouth: reduced salivation causing throat discomfort.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing requiring medical attention.
  • Severe hypotension: marked drop in blood pressure that may cause fainting.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Opioid withdrawal syndrome: symptoms of agitation, sweating, or abdominal cramps if naloxone precipitates withdrawal.

Precautions & Warnings

Before prescribing Noldoxen, clinicians should evaluate patient-specific factors and monitor for potential risks.

  • Assess pain severity: ensure opioid therapy is appropriate for the level of pain.
  • Monitor gastrointestinal function: watch for signs of constipation or diarrhea.
  • Evaluate hepatic function: adjust use in patients with liver impairment.
  • Use caution in pregnancy: category C; weigh benefits against potential risks.
  • Avoid in patients with known hypersensitivity to oxycodone or naloxone.
  • Store below 25°C: keep in the original packaging, protect from moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Concomitant use with MAO inhibitors: risk of severe serotonin syndrome.
  • Co‑administration with other central nervous system depressants (e.g., benzodiazepines): may cause profound respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may increase oxycodone plasma levels.
  • CYP3A4 inducers (e.g., rifampin): may reduce analgesic effect.
  • Anticholinergic agents: may exacerbate constipation or dry mouth.

Frequently Asked Questions

Noldoxen is prescribed to manage moderate to severe chronic pain and to treat opioid‑induced constipation. The combination of oxycodone for analgesia and naloxone to counteract gastrointestinal side effects allows clinicians to provide effective pain control while reducing the risk of constipation associated with opioid therapy.

Oxycodone activates mu‑opioid receptors in the brain and spinal cord, decreasing the transmission of pain signals and producing analgesia. Naloxone, when taken orally, remains largely confined to the gut where it blocks opioid receptors, preventing the constipating effect of oxycodone and lowering the potential for abuse if the tablet is altered.

The specific dose of Noldoxen is individualized by the prescribing healthcare professional based on the patient’s pain intensity, previous opioid exposure, renal and hepatic function, and overall clinical condition. No fixed dosing regimen is provided here; the prescriber will select the appropriate strength and frequency according to medical judgment.

Noldoxen is classified as pregnancy category C, indicating that risk to the fetus cannot be ruled out and the drug should only be used if the potential benefit justifies the potential risk. Limited data are available for breastfeeding; therefore, clinicians should assess the risk‑benefit ratio before prescribing to nursing mothers.

To request Noldoxen, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, and will ask for trade or institutional credentials. The sales team will then respond with pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Standard oxycodone provides potent analgesia but is frequently associated with opioid‑induced constipation. Noldoxen adds naloxone, which antagonizes opioid receptors in the gastrointestinal tract, thereby reducing constipation without compromising pain relief. This combination also lowers the abuse potential compared with oxycodone monotherapy, offering a safety advantage for long‑term opioid therapy.

Noldoxen should be stored below 25 °C in a dry environment. Keep the tablets in the original packaging to protect them from moisture and light. Do not store in a bathroom or near a heat source, and keep out of reach of children.

Noldoxen is taken orally, usually as a whole tablet. It should be swallowed with a full glass of water and may be taken with or without food, as directed by the prescriber. The exact timing and frequency are determined by the treating physician based on the individual’s pain management plan.

The most serious risks include respiratory depression, severe hypotension, allergic reactions such as anaphylaxis, and opioid withdrawal syndrome if naloxone precipitates abrupt antagonism. Patients should be monitored closely for signs of breathing difficulty, sudden drops in blood pressure, rash, or withdrawal symptoms, and seek immediate medical attention if they occur.

Noldoxen is contraindicated in individuals with known hypersensitivity to oxycodone, naloxone, or any component of the formulation. It should also be avoided in patients who have taken monoamine oxidase inhibitors within the past 14 days, as well as in those with severe respiratory depression, paralytic ileus, or uncontrolled asthma without appropriate medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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