Product image of Oxycodon-Hcl/Naloxon-Hcl Stada (Naloxone, Oxycodone) supplied by GNH India

Oxycodon-Hcl/Naloxon-Hcl Stada

Active Ingredient:
Naloxone, Oxycodone
Origin:
EU

Oxycodon-Hcl/Naloxon-Hcl Stada (Naloxone, Oxycodone)

International sale not permitted. Listed for the domestic market and B2B only.

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 India supplies Oxycodon-Hcl/Naloxon-Hcl Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

GNH India supplies Oxycodon-Hcl/Naloxon-Hcl Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Stadapharm Gmbh

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Indications & Clinical Uses

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.

How It Works

  • The formulation combines oxycodone, a μ‑opioid receptor agonist that produces analgesia, with naloxone, a peripheral opioid antagonist that blocks μ‑receptors in the gastrointestinal tract. When taken orally, naloxone has limited systemic absorption, allowing oxycodil to act centrally for pain relief while counteracting opioid‑induced constipation locally in the gut.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Oxycodon-Hcl/Naloxon-Hcl Stada is a combination tablet that provides strong pain relief for moderate to severe acute, chronic or postoperative pain while helping to reduce opioid‑induced constipation through the naloxone component.

Naloxone acts as a peripheral opioid antagonist that blocks μ‑receptors in the gastrointestinal tract, limiting constipation. When taken orally, it has minimal systemic absorption, allowing oxycodone to provide central analgesia while the antagonist works locally in the gut.

The prescribed dose is individualized by the treating physician based on the patient’s pain severity, prior opioid exposure, and overall health status. Clinicians determine the appropriate strength and dosing schedule for each patient.

Use during pregnancy or lactation is only considered when the potential benefit justifies potential risk to the fetus or infant. Healthcare providers should evaluate risks carefully and discuss alternatives when possible.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Unlike pure opioid analgesics, this combination includes naloxone to mitigate opioid‑induced constipation. It offers comparable pain control to other strong opioids such as morphine or pure oxycodone, but with a lower incidence of gastrointestinal side effects.

Store the tablets below 25°C in their original packaging, protecting them from moisture and direct sunlight. Keep the container tightly closed and out of reach of children.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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International sale not permitted. Listed for the domestic market and B2B only.

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