OxyContin Extended-Release Tablets 40 mg (Oxycodone Hydrochloride)

Adult dosage

1. This medicine should be taken whole; do not chew or crush it. If it is chewed or crushed, the drug may be released rapidly and an amount that could potentially cause toxicity may be absorbed. Take one tablet at a time. Place the tablet in the mouth and immediately take it with plenty of water, swallowing it completely. Regular assessment of patients receiving pain treatment is important. Review the treatment regimen regularly and adjust it based on the patient's pain and reports of adverse effects, as well as the healthcare professional's clinical judgment. This medicine is used to treat moderate to severe pain in patients who require oral opioid analgesics over several days. Take this medicine orally at 12-hour intervals. For most patients, dosing times are set symmetrically at 12-hour intervals (the same time in the morning and evening), but for some patients, an asymmetric dosing interval may be preferable depending on their pain pattern. In general, for a patient receiving continuous 24-hour therapy, it is preferable to treat with only one opioid analgesic. The dose should be determined and adjusted based on each patient's pain severity, condition, medications previously administered or currently used concomitantly, body weight, and sex (women show higher plasma concentrations), among other factors. Review the treatment regimen regularly and adjust it based on the patient's pain and reports of adverse reactions, as well as the healthcare professional's clinical judgment. In general, the lowest dose that effectively controls pain should be selected. If a higher dose is required, the dose may be increased by 25~50% of the current dose whenever possible. The dose of this medicine should be increased in patients who need rescue medication more than twice a day. This medicine should be taken consistently either with food or on an empty stomach. The appropriate dose for a patient is the dose that controls pain without causing adverse effects or while causing only tolerable adverse effects. 2. Determining the initial dose It is important to initiate treatment for each patient based on whether the patient has previously used opioid or non-opioid analgesics. Consider the patient's physical and medical condition; the type, potency, and daily dose of analgesics the patient is taking; the reliability of the conversion ratio used to calculate the oxycodone dose; the patient's history of opioid use and tolerance; and whether the benefits of analgesia outweigh the adverse effects. Use a low initial dose with caution in patients who are not opioid-tolerant, particularly those receiving concomitant muscle relaxants, sedatives, or other drugs that act on the central nervous system. - Patients who have not previously taken opioid analgesics; clinical trial results showed that patients could begin analgesic therapy with this medicine. The recommended initial dose for these patients is 10 mg of oxycodone hydrochloride every 12 hours. If the patient is taking a non-opioid analgesic [aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug], it may be continued. If the patient stops taking the currently used non-opioid analgesic, the need to increase the dose of this medicine may arise sooner. - Patients who have been taking a combination of an opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug; for patients taking 1∼5 units per day (tablets/capsules, etc.) of a combination of an opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug at the usual strength, the recommended initial dose is 10∼20 mg of oxycodone hydrochloride every 12 hours. For patients taking 6∼9 units per day (tablets/capsules, etc.) of such a combination at the usual strength, the recommended initial dose is 20∼30 mg of oxycodone hydrochloride every 12 hours; for patients taking 10∼12 units per day (tablets/capsules, etc.), the recommended initial dose is 30∼40 mg of oxycodone hydrochloride every 12 hours. The non-opioid analgesic may be taken separately, or another non-opioid analgesic may be selected. If discontinuation of the non-opioid analgesic is decided, consider that the need to increase the dose of this medicine may arise sooner. - Patients who have been taking opioid analgesics; When starting treatment with this medicine, discontinue the opioid analgesic previously administered. · The usual initial dose for patients with severe pain not controlled by a weak opioid analgesic is 10 mg every 12 hours. · Use the standard conversion ratio assessment table (Table 1) to multiply the mg/day of the previously administered opioid analgesic by the appropriate conversion factor to obtain the total equivalent daily dose of oral oxycodone. · Divide this daily oxycodone dose into 2 doses to determine the dose administered every 12 hours. · Select the dose according to the oxycodone content of the product (10, 15, 20, 30, 40, 60 and 80 mg per tablet). Drug conversion ratios are not appropriate for all patients, particularly patients who have been taking high doses of opioid analgesics. The recommended doses shown in Table 1 are initial doses; monitor patients closely and adjust the dose frequently until they adapt to the new treatment regimen. 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 = oral oxycodone dose 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 * Use only to convert doses to oral oxycodone. Greater caution is required when switching medications in patients who have been taking high doses of parenteral opioid analgesics. For example, use a conversion factor of 1.5 instead of 3 for a patient who has been receiving high doses of parenteral morphine. In any case, immediate-release oral oxycodone or another appropriate short-acting analgesic may be used as an adjunctive analgesic. This medicine may be used safely with usual doses of non-opioid analgesics or adjuvant analgesics, provided care is taken to determine an appropriate initial dose. - Switching between oral and parenteral oxycodone: The dose should follow this ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It should be emphasized that this is a guide to the required dose. Careful dose titration is necessary to determine the appropriate dose, taking into account differences between patients. - Switching from morphine: ⦁ Oral administration: For patients who took oral morphine before oxycodone treatment, calculate the daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 15 mg or 20 mg of oral morphine. It should be emphasized that this is a guide to the required dose. Careful dose titration is necessary to determine the appropriate dose, taking into account differences between patients. It is recommended that the initial dose be lower than the equivalent dose. - Patients who have been using transdermal fentanyl; treatment with this medicine may be initiated 18 hours after removal of the transdermal fentanyl patch. Although this medication switch has not been systematically evaluated, an appropriate initial oxycodone dose is approximately 10 mg of this medicine every 12 hours for each fentanyl transdermal patch delivering 25㎍/hr. Because there is limited clinical experience with this medication switch, adjust the dose early. - Individual dose adjustment; once treatment has started, frequently assess pain relief and the effects of other opioid drugs, and adjust the dose to achieve an appropriate response (generally requiring use of an analgesic adjunct about twice in 24 hours, with mild or no pain). Analgesic adjuncts may also be used. Plasma drug concentrations reach steady state in approximately 24∼36 hours, so the dose should be adjusted every 1∼2 days. During dose adjustment, it is appropriate to increase the dose administered every 12 hours while keeping the dosing interval unchanged. There is no clinical information on dosing intervals shorter than 12 hours. Except when increasing the dose from 10 mg to 20 mg every 12 hours, the guideline suggests that the total daily oxycodone dose may generally be increased by 25∼50% from the current dose with each dose increase. If opioid-related adverse effects are observed to be too severe, the next dose may be reduced. If adequate analgesia cannot be achieved with these dose adjustments, immediate-release oxycodone may be used as adjunctive therapy. A non-opioid analgesic may also be used as an adjunct. Dose adjustment aims to achieve an appropriate balance between pain relief and opioid-related adverse effects. - Dosage for 60 mg and 80 mg tablets of this medicine (use only in opioid-tolerant patients): Oxycodone doses exceeding 40 mg as a single dose or 80 mg per day may be taken only by opioid-tolerant patients. Therefore, the 60 mg and 80 mg tablets of this medicine should be used only in opioid-tolerant patients, and sufficient caution should be exercised in these cases. - Adjuvant analgesic therapy; cancer patients receiving 24-hour treatment with a controlled-release opioid analgesic may use an immediate-release medicine as rescue therapy for breakthrough pain or to prevent predictable pain during periods of activity. Immediate-release oxycodone may be used alone as a rescue medicine or in combination with acetaminophen, aspirin, or other nonsteroidal anti-inflammatory drugs as adjuvant analgesics. As shown in Table 2, the adjuvant analgesic should be prescribed at a dose of 1/4∼1/3 of the dose of this medicine administered every 12 hours. Administer the rescue medicine at a dose sufficient to treat breakthrough pain, 1 hour before the anticipated onset of pain. If rescue medication is needed more than twice within 24 hours, the dose of this medicine should be increased. Table 2. Appropriate adjuvant analgesic Dose of this medicine administered 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 The dose-adjustment method described above also applies when readjusting the dose to control pain. During continued treatment, it is advisable to periodically reassess whether continuous 24-hour therapy is needed, particularly when the pain is not due to cancer (e.g., every 6∼12 months). 4. Treatment goals and discontinuation For patients who no longer require opioid analgesic therapy, gradual dose reduction is recommended to prevent withdrawal symptoms. 5. Patients with renal impairment and patients with hepatic impairment Use with caution in patients with renal impairment or hepatic impairment, as plasma concentrations of this medicine may increase. In adult patients, the recommended initial dose should be reduced by up to 50%. (e.g., the total daily oral dose for patients who are not taking opioids is 10mg) Titrate carefully according to each patient's clinical status to achieve adequate pain control.

This medication should be swallowed whole without chewing or breaking. Chewing or breaking the tablet may result in a rapid release of the drug, which can be dangerous. This medication should only be used at high doses in patients who are tolerant to narcotic analgesics, as administration of high doses to those who have never used such medications can lead to severe respiratory depression, posing a risk to life. Care should be taken not to combine this medication with other sedatives or alcohol, as this can lead to severe drowsiness, respiratory depression, coma, or even death. Patients who have a history of allergies to the medication, severely compromised respiratory function, acute asthma, or intestinal obstruction should not take this medication. Patients with weak respiratory function, head injury, hypotension, compromised liver or kidney function, and the elderly should be particularly cautious when using this medication, adjusting the dosage and closely monitoring their condition. Long-term use of this medication can lead to tolerance, and sudden discontinuation may cause withdrawal symptoms, so the dosage should be gradually reduced according to medical advice. Side effects such as drowsiness, dizziness, nausea, constipation, headache, itching, and others may occur during use, so if symptoms are severe, patients should consult healthcare professionals. In pregnant or breastfeeding women, the use of this medication may affect the fetus or newborn, so it should only be used under medical guidance when absolutely necessary. The safety and efficacy of this medication in children under 18 years have not been established, so it is advisable not to use it in this age group. In elderly patients, treatment should begin with a lower dose that is gradually increased, with special attention to side effects such as respiratory depression. This medication should not be administered rectally and must be taken orally according to the physician's prescription. In the event of an overdose, serious symptoms such as respiratory depression, coma, and hypotension may occur, necessitating immediate emergency treatment, with opioid antagonists possibly being used as antidotes. This medication should be kept out of reach of children and stored in its original container to prevent misuse or quality degradation. Due to the risk of abuse and dependence, it is essential to strictly follow the physician’s instructions, and any signs of drug abuse should be reported to healthcare professionals. When taken in conjunction with other medications, the risk of side effects may increase due to drug interactions, so all medications being taken should be reported to healthcare providers. Care should be taken when driving or operating machinery, as this medication may impair attention.

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, erythema, anxiety, alopecia, dyspnea, orthostatic hypotension, chills, single contraction, gastritis, strange dreams, abnormal thoughts, bronchospasm, increased cough, hiccups, accidental injury, chest pain, facial swelling, discomfort, throat pain, pain, allergic reaction, drug dependence, miosis, drug tolerance, anaphylactic reaction, neonatal drug withdrawal syndrome, migraine, syncope, vasodilation, palpitations, ventricular tachycardia, dysphagia, belching, abdominal bloating, gastrointestinal disturbances, increased appetite, stomatitis, biliary pain, bowel obstruction, dental caries, cholestasis, elevated liver enzymes, lymph node disorders, dehydration, edema, hyponatremia, peripheral edema, inappropriate antidiuretic hormone secretion syndrome, thirst, abnormal gait, excitement, forgetfulness, depersonalization, depression, emotional instability, hallucinations, hyperactivity, sensory impairment, hypotonia, discomfort, sensory abnormalities, seizures, speech abnormalities, stupor, tinnitus, tremors, withdrawal symptoms not accompanied by or accompanied by seizures, convulsions, tension, involuntary muscle contractions, aggression, hyperalgesia, increased cough, pharyngitis, voice changes, central sleep apnea syndrome, dry skin, snowfall, urticaria, visual disturbances, dysgeusia, amenorrhea, decreased libido, urinary disorders, hematuria, erectile dysfunction, polyuria, urinary retention, urinary disorders, male hypogonadism, asphyxia, nausea, reflux, throat obstruction

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

30 tablets (10 tablets/PTP packaging x 3)