Europe — EMA
Oxycodon-Hcl/Naloxon-Hcl Stada (Naloxone, Oxycodone)
GNH USA supplies Oxycodon-Hcl/Naloxon-Hcl Stada (Naloxone/Oxycodone), a combination opioid analgesic and antagonist for moderate to severe pain.
International sale not permitted. Listed for the domestic market and B2B only.
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What is Naloxone, Oxycodone?
Naloxone, the active ingredient in Oxycodon-Hcl/Naloxon-Hcl Stada, is a combination opioid analgesic and opioid antagonist presented as a tablet for oral use. It is used to manage moderate to severe pain while reducing the risk of opioid‑induced respiratory depression in adult patients. GNH USA supplies Oxycodon-Hcl/Naloxon-Hcl Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
GNH USA supplies Oxycodon-Hcl/Naloxon-Hcl Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
What is Naloxone, Oxycodone used for?
Oxycodone/Naloxone is indicated for pain management in patients requiring strong opioid therapy while mitigating opioid‑induced constipation.
- Moderate to severe acute pain: provides effective analgesia while limiting opioid‑related bowel effects. - Chronic cancer‑related pain: maintains pain control with reduced risk of constipation. - Post‑operative pain: delivers postoperative analgesia with a built‑in antagonist to lessen gastrointestinal side effects. - Severe musculoskeletal pain: offers strong pain relief with a lower incidence of opioid‑induced constipation. - Palliative care pain: supports comfort in end‑of‑life care while managing opioid side effects.
What are the side effects of Naloxone, Oxycodone?
Side effects are reported from clinical use of the oxycodone/naloxone combination.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Constipation: reduced bowel movements despite antagonist effect. - Dizziness: light‑headed sensation. - Headache: transient cranial pain. - Dry mouth: decreased salivation. - Fatigue: feeling of tiredness.
Serious or Rare Side Effects: - Respiratory depression: slowed breathing requiring medical attention. - Severe hypotension: marked drop in blood pressure. - Hepatic impairment: liver function abnormalities. - Allergic reactions: rash, itching, swelling, or anaphylaxis. - Opioid withdrawal: symptoms if naloxone is systemically absorbed in high amounts. - Seizures: rare neurologic events.
What precautions apply to Naloxone, Oxycodone?
When prescribing Oxycodone/Naloxone, clinicians should consider several safety measures.
- Assess pain severity: ensure opioid therapy is appropriate for the level of pain. - Monitor for respiratory depression: watch for slowed breathing, especially after dose changes. - Evaluate liver function: adjust use in patients with hepatic impairment. - Caution in the elderly: start with lower doses and monitor for sedation. - Avoid concurrent strong CNS depressants: limit use with benzodiazepines or alcohol. - Store below 25°C: keep in the original packaging, protect from moisture and direct sunlight.
What does Naloxone, Oxycodone interact with?
Oxycodone/Naloxone may interact with several drug classes, requiring careful management.
Major Interactions (Avoid):\n- Benzodiazepines: increased risk of profound sedation and respiratory depression. - CNS depressants: additive central nervous system depression. - MAO inhibitors: heightened opioid effects and possible serotonin syndrome.
Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): may raise oxycodone plasma levels. - CYP3A4 inducers (e.g., rifampicin): may reduce analgesic efficacy. - Anticholinergics: may worsen constipation despite naloxone component. - Diuretics: potential for enhanced hypotensive effect. - Serotonergic agents: monitor for serotonin syndrome signs.
