Europe — EMA
Oxycodon-Hcl/Naloxon-Hcl Beta
Oxycodone Hydrochloride, the active ingredient in Oxycodon-Hcl/Naloxon-Hcl Beta, is an opioid analgesic presented as a combination product for oral use.
International sale not permitted. Listed for the domestic market and B2B only.
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What is Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur.?
Oxycodone Hydrochloride, the active ingredient in Oxycodon-Hcl/Naloxon-Hcl Beta, is an opioid analgesic presented as a combination product for oral use. It is indicated for the management of moderate to severe pain in adult patients. GNH USA supplies Oxycodon-Hcl/Naloxon-Hcl Beta as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
GNH USA supplies Oxycodon-Hcl/Naloxon-Hcl Beta as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.
What is Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur. used for?
Oxycodone/Naloxone is used primarily for pain management within the opioid pathway.
- Chronic non‑cancer pain: provides sustained analgesia while reducing opioid‑induced constipation. - Cancer‑related pain: delivers strong opioid relief for breakthrough and background pain. - Post‑operative pain: offers effective short‑term analgesia after surgical procedures. - Acute severe pain: rapidly controls intense pain episodes such as trauma or renal colic. - Palliative care: improves comfort in end‑of‑life settings by managing severe pain. - Opioid rotation : facilitates switch to a different opioid regimen with lower gastro‑intestinal side‑effects.
What are the side effects of Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur.?
Side effects are reported across a range of severities.
Common Side Effects: - Nausea and vomiting: mild to moderate gastrointestinal upset. - Constipation: reduced bowel motility despite naloxone presence. - Dizziness or light‑headedness: transient vestibular effects. - Somnolence: increased sleepiness or fatigue. - Dry mouth: reduced salivary flow. - Pruritus: mild skin itching.
Serious or Rare Side Effects: - Respiratory depression: significant reduction in breathing rate. - Severe hypotension: marked drop in blood pressure. - Allergic reactions: rash, urticaria, or anaphylaxis. - Opioid dependence or withdrawal: signs of physical dependence. - Hepatic impairment: elevated liver enzymes. - Seizures: rare neurologic events.
What precautions apply to Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur.?
When prescribing Oxycodon‑Hcl/Naloxon‑Hcl Beta, clinicians should consider several safety measures.
- Assess pain severity: confirm that opioid therapy is appropriate. - Review medical history: identify respiratory, hepatic or renal conditions. - Monitor for dependence: watch for signs of misuse or addiction. - Avoid abrupt discontinuation: taper dose to prevent withdrawal. - Concomitant CNS depressants: use with caution alongside benzodiazepines or alcohol. - Store at ambient temperature: keep in the original packaging, protect from moisture and light.
What does Naloxone Hydrochloride Dihydrate, Oxycodone Hydrochloride Ph. Eur. interact with?
Oxycodon‑HCl & Naloxone‑HCl combination may inter act with several medications.
Major Interactions (Avoid): - C - M - O - S - T Moderate Moderate ... - C - D - """"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""
Product details
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