■ Patients with severe cancer who require long-term pain control.■ Patients with chronic moderate to severe non-cancer pain who require long-term pain control and have previously taken opioids that are ineffectivepain controller·■ Children and patients who can tolerate opioids — aged 11 or older and currently receiving at least the minimum daily dose of opioids (e.g., 20 mg oral oxycodone or an equivalent dose). 【文字內容來自仿單】

Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression

■ Time to peak, plasma:4 to 5 hours.■ Duration: ?12 hours.■ Distribution: - Children 2 to 10 years: Vd 2.1 L/kg (range: 1.2 to 3.7 L/kg)- Adults: Vd 2.6 L/kg; distributed to skeletal muscle, liver, intestinal tract, lungs, spleen, and brain.■ Protein binding: 38% to 45%.■ Bioavailability: 60% to 87%■ Half-life:4.5 hours■ Elimination: - Children 2 to 10 years: 1.8 hours (range: 1.2 to 3 hours)- Adults: 3.7 hours.■ Excretion: Urine: (~10% as parent; ~65% as metabolites [noroxycodone (23%, active), oxymorphone (10%, active), noroxymorphone (14%, weakly active), reduced metabolites (?18%)]) (Kinnunen 2019).

1. Significant respiratory depression2. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment3. Known or suspected paralytic ileus or gastrointestinal obstruction4. Hypersensitivity to oxycodone (e.g., systemic allergic reactions)【文字內容來自於仿單】

Use of Oxycontin for an extended period of time during pregnancy can cause withdrawal symptoms in newborn baby that could be lifethreatening if not recognized and treated.

Not recommended during treatment with Oxycontin

■ Addiction, Abuse, and Misuse ■ Life-Threatening Respiratory Depression ■ Interactions With Benzodiazepines and Other CNS Depressants ■ Neonatal Opioid Withdrawal Syndrome ■ Opioid-Induced Hyperalgesia and Allodynia ■ Adrenal Insufficiency ■ Severe Hypotension ■ Gastrointestinal Adverse Reactions■ Seizures ■ Withdrawal

■ Opioid-naive patients: 10mg q12H■ Opioid-tolerant patientsPatients who have been receiving opioid analgesics (e.g., ?60 mg of oral morphine per day, ?25 mcg/hour of transdermal fentanyl, ?30 mg of oral oxycodone per day, ?8 mg of oral hydromorphone per day, ?25 mg of oral oxymorphone per day, ?60 mg of oral hydrocodone per day, or another opioid providing equivalent analgesia) for one week or longer are considered opioid-tolerant and may receive single doses of oxycodone exceeding 40 mg, or total daily doses exceeding 80 mg administered every 12 hours. 【文字內容來自於仿單】

Use only in pediatric patients ?11 years of age who are already receiving opioid therapy for ?5 consecutive days, tolerating a minimum daily opioid dose of ?20 mg of oxycodone orally or its equivalent at least for the 2 days immediately prior to starting extended-release oxycodone tablets, and for which alternative treatment options are inadequate. Prior to initiation, all other around-the-clock opioid therapy must be discontinued. ■ Initial dose: Based on current opioid regimen dose. ■ Initial dose of every 12 hours = (mg/day of current opioid regimen X conversion factor)/2

■ CrCl ?60 mL/minute: No dosage adjustment necessary.■ CrCl 30 to <60 mL/minute: Administer 50% to 75% of usual dose every 12 to 24 hours; if the reduced dose is less than smallest available dosage form, consider alternative analgesic.■ CrCl <30 mL/minute:should preferably be avoided in patients with severe impairment■ Hemodialysis, intermittent (thrice weekly):should preferably be avoided in patients with severe impairment ■ Peritoneal dialysis:should preferably be avoided in patients with severe impairment■ CRRT、PIRRT : Avoid use

Child-Turcotte-Pugh class A through C : Avoid use

Store at 25°C, and dispense in tight, light-resistant container.