Oxycodone Hydrochloride

What it is and how it works

Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown.

Indications

Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration , reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Oxycodone hydrochloride are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Dosage and administration (summary)

Oxycodone hydrochloride should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of oxycodone hydrochloride for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.

Contraindications

Oxycodone hydrochloride are contraindicated in patients with: Significant respiratory depression . Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia . Known or suspected gastrointestinal obstruction, including paralytic ileus . Known hypersensitivity (e.g., anaphylaxis) to oxycodone .

Warnings and precautions

Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration.

Pregnancy

Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome . Available data with oxycodone hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes.

Storage and supply

Oxycodone Hydrochloride Tablets, USP 5 mg: white, round, convex, scored tablets, debossed "4810" on one side and debossed "V" on the reverse side, are supplied as follows: Bottles of 10: NDC 76420-362-10 (repackaged from NDC 64380-259-XX) Bottles of 30: NDC 76420-362-30 (repackaged from NDC 64380-259-XX) Bottles of 60: NDC 76420-362-60 (repackaged …

Source: Oxycodone Hydrochloride (Oxycodone Hydrochloride) — US FDA prescribing information, 2025-12-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.