Oxycontin Extended-release Tablets 10 mg (Oxycodone Hydrochloride)

Adult dosage

This medicine must be swallowed one tablet at a time. Take this medicine orally at 12-hour intervals. For most patients, the dosing times are set symmetrically at 12-hour intervals (the same time in the morning and evening), but for some patients, it may be preferable to set asymmetric dosing intervals according to their pain pattern. In general, it is preferable to treat a patient with only one opioid analgesic for 24-hour around-the-clock therapy. In general, the lowest dose that is effective for pain should be selected. If a higher dose is needed, the dose may be increased, whenever possible, by 25~50% of the current dose. The dose of this medicine should be increased for patients who need rescue medication more than 2 times a day. Take this medicine consistently either with food or on an empty stomach. - Patients who have not previously taken opioid analgesics; the recommended initial dose for these patients is 10 mg of oxycodone hydrochloride every 12 hours. - Patients who have been taking combination products containing an opioid analgesic/aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug; for patients who have been taking 1∼5 units per day (tablets/capsules, etc.) of a usual-dose combination product containing an opioid analgesic/aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug, the recommended initial dose is 10∼20 mg of oxycodone hydrochloride every 12 hours. For patients who have been taking 6∼9 units per day (tablets/capsules, etc.) of a usual-dose combination product containing an opioid analgesic/aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug, the recommended initial dose is 20∼30 mg of oxycodone hydrochloride every 12 hours; for patients who have been taking 10∼12 units per day (tablets/capsules, etc.), the recommended initial dose is 30∼40 mg of oxycodone hydrochloride every 12 hours. - Patients who have been taking opioid analgesics; ·The usual initial dose for patients with severe pain that is not controlled by a weak opioid analgesic is 10mg every 12 hours. ·Use the standard conversion ratio assessment table (Table 1) and multiply the previous opioid analgesic dose in mg/day by the appropriate conversion factor to calculate the equivalent total daily dose of oral oxycodone. ·Divide this daily oxycodone dose into 2 doses to determine the dose to be given every 12 hours. ·Select the dose according to the oxycodone content of the formulation (10, 15, 20, 30, 40, 60 and 80 mg per tablet). Table 1. Standard conversion ratio assessment table for converting the daily dose of an opioid analgesic being taken to the daily dose of oral oxycodone* (dose of current medication in mg/day × conversion factor = dose of oral oxycodone in 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 - Conversion between oral and parenteral oxycodone: The dose is based on the following ratio: 2mg of oral oxycodone is equivalent to 1mg of parenteral oxycodone. -Conversion from morphine: ⦁Oral administration: For patients who were taking oral morphine before oxycodone treatment, calculate the daily dose based on the following ratio: 10mg of oral oxycodone is equivalent to 15mg or 20mg of oral morphine. Initially, a dose lower than the equivalent dose is recommended. - Patients who have been receiving transdermal fentanyl; treatment with this medicine may be initiated 18 hours after removal of the transdermal fentanyl patch. An appropriate initial oxycodone dose is to replace each fentanyl transdermal patch delivering 25㎍/hr with approximately 10 mg of this medicine every 12 hours. - Individual dose adjustment; analgesic adjuvants may also be used. Since steady-state plasma concentrations are reached within approximately 24∼36 hours, the dose should be adjusted every 1∼2 days. During dose adjustment, it is appropriate to increase the dose of medicine given every 12 hours while maintaining the same dosing interval. There are no clinical data on dosing intervals shorter than 12 hours. Guidelines state that, except when increasing the dose from 10 mg to 20 mg every 12 hours, the total daily oxycodone dose may generally be increased by 25∼50% of the current dose at each dose increase. If adequate analgesia cannot be achieved with these dose adjustments, immediate-release oxycodone may be used as adjunctive therapy. - Dosage for 60 mg and 80 mg tablets of this medicine (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. Therefore, the 60 mg and 80 mg tablets of this medicine should be used only in patients tolerant to opioid analgesics, and sufficient caution should be exercised in such cases. - Analgesic adjuvant therapy; prescribe analgesic adjuvants at 1/4∼1/3 of the dose of this medicine given every 12 hours, as shown in Table 2. Administer rescue medication at a dose capable of treating breakthrough pain, 1 hour before the time when pain is expected to occur. If rescue medication is needed 2 or more times within 24 hours, the dose of this medicine should be increased. Table 2. Appropriate analgesic adjuvant doses Dose of this medicine given every 12 hours (mg) / Dose of rescue medication used as needed, immediate-release oxycodone (㎎) 10 / 5 20 / 5 30 / 10 40 / 10 60 / 15 80 / 20 120 / 30 160 / 40 240 / 60 3. Maintenance therapy If pain recurs, an increase in the dose of the medicine is needed to control the pain. The dose adjustment method described above also applies when readjusting the dose to control pain. During long-term treatment, it is advisable to periodically reassess whether 24-hour around-the-clock therapy is needed, particularly when the pain is not due to cancer (e.g., every 6∼12 months). For patients who no longer require opioid analgesic treatment, gradual dose reduction is recommended to prevent withdrawal symptoms. 5. 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 using opioid analgesics is 10mg) Administer with careful titration according to the individual patient's clinical condition to achieve adequate pain control.

This medication should be swallowed whole and not chewed or crushed. Chewing or crushing can cause rapid release of the drug, potentially resulting in serious side effects. High-dose formulations of this medication should only be used in patients already tolerant to narcotic analgesics. If a patient without this tolerance takes a high dose, it can severely depress respiration and pose risks. Caution is essential when taken with central nervous system depressants or alcohol, as it may lead to severe drowsiness, respiratory depression, coma, or even death. This medication should not be administered to patients with certain conditions or those taking specific medications; for example, it can be dangerous for patients with significantly impaired respiratory function or asthma. Patients with poor respiratory function, head injuries, low blood pressure, etc., should use this medication with particular caution and monitor for side effects closely. This medication should not be used in patients with bowel obstruction or gastrointestinal obstruction, and care should be taken when used in patients with gastrointestinal diseases. Prolonged use can lead to tolerance and physical dependence on the drug, and sudden discontinuation may cause withdrawal symptoms. Gradually tapering off the dosage is recommended for safety. Use of this medication with alcohol or other central nervous system depressants can exacerbate side effects, thus co-administration should be avoided. Avoid driving or operating machinery while taking this medication, as it may cause drowsiness or dizziness. During pregnancy, this medication should only be used when necessary, as newborns may experience respiratory depression or withdrawal symptoms after delivery. During breastfeeding, this medication may pass into breast milk and affect the infant, hence breastfeeding should be avoided. Elderly patients may have slower drug metabolism and a higher risk of side effects; therefore, dosage should be reduced and used with caution. Overdose of this medication can lead to severe respiratory depression, coma, heart problems, etc., necessitating immediate emergency treatment. Keep this medication out of reach of children and store it in the original container to prevent misuse. Take this medication according to the doctor's instructions regarding the exact dosage and method, and do not alter the dosage without consultation. This medication carries a risk of abuse and addiction, so it is important to regularly consult with a physician regarding its use and immediately report any unusual symptoms.

Respiratory depression, apnea, respiratory arrest, decreased circulatory system function, hypotension, shock, constipation, nausea, drowsiness, dizziness, itching, headache, dry mouth, sweating, weakness, loss of appetite, irritability, insomnia, fever, confusion, diarrhea, abdominal pain, indigestion, redness, anxiety, hyperkinesia, dyspnea, orthostatic hypotension, chills, single contraction, gastritis, bizarre dreams, abnormal thought processes, bronchospasm, increased cough, hiccups, inadvertent injury, chest pain, facial swelling, malaise, throat pain, pain, allergic reactions, drug dependence, mydriasis, drug tolerance, anaphylactic reaction, 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, increased liver enzymes, lymph node disorders, dehydration, edema, hyponatremia, peripheral edema, inappropriate antidiuretic hormone secretion syndrome, thirst, abnormal gait, agitation, forgetfulness, depersonalization, depression, emotional instability, hallucinations, hyperactivity, sensory impairment, hypotonia, malaise, sensory abnormalities, seizures, language abnormalities, confusion, tinnitus, tremors, withdrawal symptoms with or without seizures, convulsions, tension headaches, involuntary muscle contractions, aggression, hyperalgesia, central sleep apnea syndrome, dry skin, snowfall, hives, visual disturbances, taste disorders, amenorrhea, decreased libido, urinary disorders, hematuria, erectile dysfunction, polyuria, urinary retention, male reproductive gland hypofunction, asphyxia, nausea, reflux, throat obstruction

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, it is recommended to store it at room temperature between 1°C and 30°C. This helps maintain the effectiveness of the medication.

Appearance

White, double convex, round, extended-release film-coated tablets

Package unit

30 tablets (10 tablets/PTP packaging X 3)