OxyContin Extended-Release Tablets 80mg (Oxycodone Hydrochloride)

Adult dosage

This medication is taken orally at 12-hour intervals. If a higher dose is required, the dose may be increased, where possible, by 25~50% of the current dose. The dose of this medication should be increased in patients who require rescue medication more than 2 times a day. Patients who have not previously taken opioid analgesics: The recommended initial dose is 10 mg of oxycodone hydrochloride every 12 hours. Patients taking 1∼5 units per day (tablets/capsules, etc.) of a combination of a standard dose opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug: The recommended initial dose is 10∼20 mg of oxycodone hydrochloride every 12 hours. Patients taking 6∼9 units per day (tablets/capsules, etc.) of a combination of a standard dose opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug: The initial dose is 20∼30 mg of oxycodone hydrochloride every 12 hours. Patients taking 10∼12 units per day (tablets/capsules, etc.) of a combination of a standard dose opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug: The recommended initial dose is 30∼40 mg of oxycodone hydrochloride every 12 hours. The usual initial dose for patients with severe pain not controlled by a weak opioid analgesic is 10 mg every 12 hours. Using the standard conversion ratio assessment table (Table 1), multiply the appropriate conversion factor by the mg/day of the opioid analgesic previously administered to calculate the total equivalent daily dose of oral oxycodone. Divide this daily oxycodone dose into 2 doses to determine the dose to be administered every 12 hours. Determine the dose according to the oxycodone content of the formulation (10, 15, 20, 30, 40, 60 and 80 mg per tablet). Dose of current medication mg/day × conversion factor = oral oxycodone dose mg/day Current oral medication / Current parenteral medication Oxycodone: 1 / - Codeine: 0.15 / - Fentanyl TTS: see below / see below Hydrocodone: 0.9 / - Hydromorphone: 4 / 20 Levorphanol: 7.5 / 15 Meperidine: 0.1 / 0.4 Methadone: 1.5 / 3 Morphine: 0.5 / 3 For patients receiving high doses of parenteral morphine, use a conversion factor of 1.5 instead of 3. 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. Oral administration: 10 mg of oral oxycodone is equivalent to 15 mg or 20 mg of oral morphine. It is recommended that the initial dose be lower than the equivalent dose. Treatment with this medication may be initiated 18 hours after removal of a transdermal fentanyl patch. For each fentanyl transdermal patch delivering 25㎍/hr, substitute approximately 10 mg of this medication every 12 hours. Pain relief and the effects of other opioid medications should be assessed frequently, and the dose should be adjusted to achieve an adequate effect (typically using an analgesic adjunct about 2 times over 24 hours, with mild or no pain). Since plasma drug concentrations reach steady state within approximately 24∼36 hours, the dose should be adjusted every 1∼2 days. Guidelines suggest that, except when increasing the dose from 10 mg to 20 mg every 12 hours, the total daily dose of oxycodone may generally be increased by 25∼50% of the current dose with each dose increase. Dosage for 60 mg and 80 mg tablets of this medication (for use only in patients tolerant to opioid analgesics): Oxycodone doses exceeding 40 mg per dose or 80 mg per day may be used only in patients tolerant to opioid analgesics. Adjunctive analgesia: As shown in Table 2, an analgesic adjunct should be prescribed at 1/4∼1/3 of the dose of this medication administered every 12 hours. Administer the rescue medication at a dose sufficient to treat breakthrough pain, 1 hour before the predicted onset of pain. If rescue medication is needed more than 2 times within 24 hours, the dose of this medication should be increased. Dose of this medication administered every 12 hours (mg) / Dose of immediate-release oxycodone used as rescue medication as needed (㎎) 10 / 5 20 / 5 30 / 10 40 / 10 60 / 15 80 / 20 120 / 30 160 / 40 240 / 60 During long-term treatment, it is advisable to periodically reassess whether 24-hour continuous therapy is necessary, particularly when the pain is not due to cancer (e.g., every 6∼12 months). Patients with renal impairment and patients with hepatic impairment: The recommended initial dose in adult patients should be reduced by up to 50%. (e.g., the total daily oral dose for patients not taking opioid analgesics is 10mg) Titrate cautiously according to each patient's clinical condition to achieve adequate pain control.

This medication should be swallowed whole without chewing or crushing. If crushed or chewed, the drug may be released suddenly in a high dose, which can be dangerous. This drug should only be used in patients who are tolerant to opioid analgesics, as those without tolerance may experience severe respiratory depression. When taken with central nervous system depressants or alcohol, it can lead to severe sedation, respiratory depression, coma, or even death, so caution is imperative when combining these treatments. This medication should not be administered to patients with hypersensitivity to oxycodone, severe respiratory impairment, acute asthma, or suspected or confirmed bowel obstruction. Patients with impaired respiratory function, head injuries, hypotension, or severe liver or kidney impairment should use this drug with special caution. Long-term use may lead to tolerance to the medication, and suddenly stopping it may cause withdrawal symptoms, so the dosage must be gradually reduced. Taking this medication with alcohol or other central nervous system depressants can exacerbate side effects, so they should not be taken together. During pregnancy, it should only be used when necessary, and it is advisable to avoid its use immediately before or during childbirth due to the risk of respiratory depression in neonates. Breastfeeding should be avoided as this medication can be transmitted in breast milk, possibly causing sedation or respiratory depression in the infant. This medication is not used in children under 18 years of age, as safety and efficacy have not been established. In elderly patients, the dosage should be reduced and administered cautiously, especially as the risk of respiratory depression is greater. Patients should adhere to the prescribed dosage, swallow the tablets whole without cutting or crushing, and keep the medication out of reach of children. In case of overdose, severe respiratory depression and coma may occur, requiring immediate medical attention and potentially the administration of an antidote. This medication may impair the ability to drive or operate machinery, so caution is advised post-administration. There is a risk of drug abuse and dependency, so it should only be taken according to a doctor's instructions, avoiding any misuse or abuse.

Respiratory depression, apnea, respiratory arrest, cardiovascular depression, hypotension, shock, constipation, nausea, drowsiness, dizziness, itching, headache, dry mouth, sweating, weakness, loss of appetite, irritability, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, redness, anxiety, hyperesthesia, dyspnea, orthostatic hypotension, chills, single contraction, gastritis, strange dreams, abnormal thoughts, bronchospasm, increased cough, hiccups, accidental injury, chest pain, facial swelling, malaise, throat pain, pain, allergic reaction, drug dependence, mydriasis, drug tolerance, anaphylaxis, neonatal drug withdrawal syndrome, migraine, syncope, vasodilation, palpitations, supraventricular tachycardia, dysphagia, belching, abdominal distension, gastrointestinal disorders, increased appetite, stomatitis, biliary pain, intestinal obstruction, dental caries, cholestasis, elevated liver enzymes, lymphadenopathy, dehydration, edema, hyponatremia, peripheral edema, inappropriate antidiuretic hormone secretion syndrome, thirst, abnormal gait, agitation, amnesia, depersonalization, depression, emotional instability, hallucinations, hyperactivity, sensory decline, hypotonia, malaise, paresthesia, seizures, language difficulties, confusion, tinnitus, tremors, withdrawal symptoms without or with seizures, spasms, tension headaches, involuntary muscle contractions, aggression, hyperalgesia, central sleep apnea syndrome, skin dryness, snowfall, urticaria, visual disturbances, dysgeusia, amenorrhea, decreased libido, urination disorders, hematuria, erectile dysfunction, polyuria, urinary retention, male reproductive gland hypofunction, asphyxia, nausea, reflux, throat obstruction, dysphagia, drowsiness, skeletal muscle relaxation, cold, sticky skin, miosis, pulmonary edema, bradycardia, partial or complete airway obstruction, irregular snoring, death, toxic white matter encephalopathy

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is advisable to maintain storage temperatures between 1°C and 30°C at room temperature. Proper storage will help retain the drug's efficacy for a longer period.

Appearance

Green, round, biconvex, extended-release film-coated tablet

Package unit

30 tablets (10 tablets in PTP packaging x 3)