Oxycodone HCl 80 mg

Descrizione Del Prodotto

Oxycodone Hydrochloride 80 mg extended-release oral tablets deliver a high concentration of a semi-synthetic $\mu$-opioid receptor agonist designed to provide sustained 12-hour analgesia. Indicated solely for opioid-tolerant patients managing persistent, severe chronic pain—such as advanced cancer pain or intractable non-malignant chronic conditions—the formulation maintains stable plasma drug concentrations over an extended dosing interval, minimizing breakthrough pain episodes.

Clinical Profile & Physical Identification

• Active Ingredient: Oxycodone Hydrochloride (80 mg)

• Appearance & Imprint: Round, green, biconvex tablet debossed with “OC” on one side and “80” on the reverse.

• Mechanism of Action: Acts as a full agonist at central nervous system $\mu$-opioid receptors. Receptor binding couples to inhibitory G-proteins, inhibiting adenylyl cyclase, closing voltage-gated calcium channels, and opening inwardly rectifying potassium channels. This hyperpolarizes ascending pain projection neurons, dampening nociceptive signal transmission across the spinal dorsal horn and thalamic pathways.

• Pharmacokinetics & Release Profile: Provides a biphasic release pattern with an initial absorption phase followed by prolonged systemic delivery over 12 hours. Peak concentrations occur within 4.5 to 5 hours, with hepatic biotransformation governed predominantly by CYP3A4 (forming noroxycodone) and CYP2D6 (forming oxymorphone).

Opioid Tolerance Requirement & Prescribing Guidelines

• Opioid-Tolerant Restriction: Single doses greater than 40 mg or total daily doses greater than 80 mg are restricted strictly to opioid-tolerant patients. Patients are considered opioid-tolerant if they have received at least 60 mg oral morphine daily, 30 mg oral oxycodone daily, or an equianalgesic dose of another opioid continuously for one week or longer.

• Fatal Risk in Opioid-Naive Patients: Administration of an 80 mg oxycodone dose to an opioid-naive individual can precipitate immediate, fatal respiratory arrest.

• Administration Integrity: Tablets must be swallowed whole. Chewing, crushing, splitting, snorting, or dissolving the tablet destroys the extended-release mechanism, leading to rapid systemic dumping of a potentially lethal dose of oxycodone.

Important Safety Information & Boxed Warnings

• Addiction, Abuse, and Misuse: Oxycodone is a Schedule II controlled substance carrying high risks of psychological and physical dependence, severe misuse, and diversion, which can lead to fatal overdose.

• Life-Threatening Respiratory Depression: Severe, potentially fatal respiratory depression can occur at any stage of therapy, with highest vulnerability present during dosage adjustments or improper ingestion.

• Concomitant Use with Benzodiazepines & CNS Depressants: Concurrent administration with benzodiazepines, tranquilizers, sedatives, or alcohol can cause profound lethargy, respiratory collapse, coma, and death.

• Accidental Ingestion: Ingestion of a single tablet by a child or unauthorized person