Oxycodone CR

OXYCONTIN

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What it isControlled-release full mu-opioid agonist dosed q12h; severe chronic pain requiring continuous opioid therapy.

Why this oneThe 2010 abuse-deterrent reformulation is harder to manipulate but does not make the drug abuse-proof.

What limits itRespiratory depression and overdose worsen with benzodiazepines or other depressants; never crush the tablet.

FDA-approved for

chronic pain (around-the-clock) (1995)

FDA label

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BOXED WARNING Addiction, abuse, and misuse (can lead to overdose and death); life-threatening respiratory depression (swallow tablets whole); accidental ingestion (fatal in children); neonatal opioid withdrawal syndrome (NOWS); risk from concomitant use with benzodiazepines or other CNS depressants; CYP3A4 interactions; Opioid Analgesic REMS.

FDA dosing	Population	Start	Target	Max
Severe and persistent pain requiring daily, around-the-clock, long-term opioid treatment (not as-needed)	Adults (not opioid-tolerant)	10 mg PO every 12 hours		60/80 mg tablets, single dose >40 mg, or total daily dose >80 mg only if opioid-tolerant
Severe and persistent pain requiring daily, around-the-clock opioid treatment	Peds ≥11 yr, opioid-tolerant (already ≥20 mg/day oxycodone or equivalent)	Convert from prior opioid per Table 1; not appropriate if total daily dose would be <20 mg

Titration May adjust dosage every 1–2 days (steady state approximated in ~1 day)

Renal CrCl <60 mL/min: oxycodone concentrations ~50% higher; use conservative dose initiation and adjust to clinical situation

Hepatic Start at one-third to one-half the usual starting dosage and titrate carefully

Every-12-hour scheduled dosing; not indicated as a PRN analgesic

Instructions

Swallow tablets whole, one at a time, with enough water; do not cut, break, chew, crush, or dissolve
Do not pre-soak, lick, or wet the tablet
Administered every 12 hours; not for as-needed (PRN) use
Taper gradually to discontinue in physically dependent patients

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus

Cautions

Opioid-induced hyperalgesia and allodynia
Life-threatening respiratory depression in chronic pulmonary disease or elderly/cachectic/debilitated patients
Adrenal insufficiency
Severe hypotension (avoid in circulatory shock)
Increased intracranial pressure / head injury / impaired consciousness
Difficulty swallowing and risk of GI obstruction
Seizures in patients with seizure disorders
Serotonin syndrome with serotonergic drugs