OxyContin 40mg

Product Description

OxyContin 40 mg oral tablets deliver a high-potency, semi-synthetic $\mu$-opioid agonist via an advanced extended-release (ER) delivery system. Indicated strictly for severe, chronic, around-the-clock pain profiles, this formulation allows for a 12-hour dosing interval by continuously releasing oxycodone to maintain stable therapeutic plasma levels, reducing the peak-and-trough fluctuations common with immediate-release opioids.

Clinical Profile & Physical Identification

• Active Ingredient: Oxycodone Hydrochloride (40 mg)

• Appearance & Imprint: Yellow, round, bi-convex tablet debossed with “OP” on one side and “40” on the reverse.

• Abuse-Deterrent Formulation: Manufactured using a specialized physicochemical polymer matrix designed to resist physical manipulation (crushing, grinding, or chewing) and chemical extraction. If exposed to aqueous solvents, the tablet forms a viscous hydrogel that resists syringe injection.

• Pharmacokinetics: Exhibits a biphasic absorption profile, providing an initial release of medication followed by a prolonged, steady release over 12 hours. Extensively metabolized in the liver via CYP3A4 and CYP2D6 enzymes.

Indications & Clinical Administration

• Around-the-Clock Analgesia: Indicated for severe pain requiring continuous, long-term opioid therapy where non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or would be otherwise inadequate.

• Strict Administration Protocol: Tablets MUST be swallowed whole with enough water to ensure complete swallowing immediately after placing in the mouth. Crushing, chewing, breaking, or dissolving the tablet defeats the extended-release mechanism, leading to rapid systemic absorption of a potentially fatal dose of oxycodone.

Important Safety Information & Boxed Warnings

• Addiction, Abuse, and Misuse: As a Schedule II controlled substance, OxyContin exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Peak risk occurs during initiation of therapy or following a dose increase.

• Accidental Ingestion: Accidental ingestion of even one dose of OxyContin, especially by children, can result in a fatal overdose of oxycodone.

• Risks from Concomitant Use with Benzodiazepines & CNS Depressants: Co-administration with benzodiazepines, alcohol, or other central nervous system depressants significantly increases the risk of profound sedation, respiratory depression, coma, and death.

• Cytochrome P450 3A4 Interaction: Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal increase in oxycodone plasma concentrations.