Europe — EMA
Noldoxen (Naloxone Hydrochloride, Oxycodone Hydrochloride)
GNH USA supplies Noldoxen (Naloxone/Oxycodone), an opioid analgesic for chronic pain and opioid‑induced constipation. Request a quote for global supply.
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What is 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 USA supplies Noldoxen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Naloxone Hydrochloride, Oxycodone Hydrochloride used for?
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.
What are the side effects of Naloxone Hydrochloride, Oxycodone Hydrochloride?
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.
What precautions apply to Naloxone Hydrochloride, Oxycodone Hydrochloride?
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.
What does Naloxone Hydrochloride, Oxycodone Hydrochloride interact with?
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.



