Oxycodone Extended Release Tablets 40 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, dosing times are set symmetrically at 12-hour intervals (the same times in the morning and evening), but for some patients, an asymmetric dosing interval may be preferable depending on their pain pattern. Generally, for continuous 24-hour therapy, it is best to treat an individual patient with only one opioid analgesic. In general, the lowest dose that effectively relieves pain should be selected. If a higher dose is needed, the dose may be increased by 25~50% of the current dose, if possible. The dose of this medicine should be increased for patients who need rescue medication more than 2 times a day. This medicine should be taken 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 were taking a combination product containing an opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug; for patients taking 1∼5 units (tablets/capsules, etc.) per day of a combination product containing a usual dose of an 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. For patients taking 6∼9 units (tablets/capsules, etc.) per day of a combination product containing a usual dose of an opioid analgesic and aspirin, acetaminophen, or a nonsteroidal anti-inflammatory drug, the recommended initial dose is 20∼30 mg of oxycodone hydrochloride every 12 hours; for patients taking 10∼12 units (tablets/capsules, etc.) per day, the recommended initial dose is 30∼40 mg of oxycodone hydrochloride every 12 hours. - Patients who were taking opioid analgesics; · 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 mg/day of the previously administered opioid analgesic by the appropriate conversion factor to determine the total equivalent daily dose of oral oxycodone. · Divide this daily oxycodone dose into 2 doses to determine the dose to be taken 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 the 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 - Conversion between oral and parenteral administration of oxycodone: The doses are converted according to the following ratio: 2mg of oral oxycodone is equivalent to 1mg of parenteral oxycodone. - Conversion from morphine: ⦁ Oral administration: For patients who took oral morphine before oxycodone therapy, the daily dose is calculated based on the following ratio: 10mg of oral oxycodone is equivalent to 15mg or 20mg of oral morphine. It is recommended that the initial dose be lower than the equivalent dose. - Patients receiving transdermal fentanyl; treatment with this medicine may be started 18 hours after removal of the transdermal fentanyl patch. An appropriate initial oxycodone dose is approximately 10 mg of this medicine every 12 hours for each fentanyl transdermal patch delivering 25㎍/hr. - Individual dose adjustment; analgesic adjuvants may also be used. Since steady-state plasma drug concentrations are reached in approximately 24∼36 hours, 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 are no clinical data on dosing intervals shorter than 12 hours. Except when increasing the dose from 10 mg to 20 mg every 12 hours, guidelines indicate that the total daily dose of oxycodone may generally be increased by 25∼50% of the current dose with each dose increase. If adequate pain relief cannot be achieved with these dose adjustments, immediate-release oxycodone may be used as adjuvant therapy. - Dosage of this medicine 60 mg and 80 mg tablets (for use only in patients tolerant to opioid analgesics): Oxycodone doses exceeding 40 mg per dose or 80 mg per day may be taken only by patients tolerant to opioid analgesics. Therefore, this medicine 60 mg and 80 mg tablets should be used only in patients tolerant to opioid analgesics, and sufficient caution should be exercised in such cases. - Analgesic adjuvant therapy; as shown in Table 2, analgesic adjuvants should be prescribed at 1/4∼1/3 of the dose of this medicine administered every 12 hours. Rescue medication should be administered at a dose sufficient to treat breakthrough pain, 1 hour before the anticipated onset of pain. If rescue medication is needed more than 2 times within 24 hours, the dose of this medicine should be increased. Table 2. Appropriate analgesic adjuvant doses 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 the dose is readjusted to control pain. During long-term treatment, particularly when the pain is not due to cancer, it is advisable to periodically reassess whether continuous 24-hour therapy is needed (e.g., every 6∼12 months). 4. Discontinuation of treatment Reduce the daily dose by approximately 50% during the first 2 days, and thereafter reduce it by 25% every 2 days until reaching the recommended dose for patients starting opioid analgesics (10 or 20 mg every 12 hours). Treatment may then be discontinued. If withdrawal symptoms occur, stop reducing the dose and increase the dose slightly until the withdrawal symptoms disappear. Dose reduction may then be resumed, but the intervals between dose reductions should be longer. 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 taking opioid analgesics is 10mg) The dose should be carefully titrated according to the individual patient's clinical condition to achieve adequate pain control.

This medication must be swallowed whole without chewing or crushing, as especially for patients using opioid analgesics for the first time, the sudden release of the drug can be dangerous. High-dose formulations of this medication should only be used in patients who are already tolerant to opioid analgesics; administering it to those without tolerance can lead to serious respiratory depression. Caution is also required when taking this medication with central nervous system depressants or alcohol, as it can cause severe drowsiness, respiratory decrease, coma, and possibly death. Patients with allergies to this medication or those with severely impaired respiratory function, severe asthma, or bowel obstruction should not be administered this medication. Patients with weak respiratory function or chronic lung disease, head trauma, hypotension, or impaired liver or kidney function should be particularly cautious when using this medication. This medication can cause tolerance and physical dependence, and discontinuing it suddenly may cause withdrawal symptoms; therefore, the dosage should be reduced gradually according to the physician's instructions. Patients should avoid driving or operating machinery while taking this medication, and it should be kept out of reach of children. Women who are pregnant or breastfeeding should consult their physician before using this medication, especially before or during childbirth. Elderly patients may experience stronger effects from this medication, so the dose should be started lower and used cautiously. In cases of overdose, severe respiratory depression, coma, and death can occur, and immediate medical attention should be sought, with detoxification agents administered as necessary. Due to the high potential for drug interactions, especially with sedatives, antidepressants, antibiotics, and anticonvulsants, it is essential to inform the physician or pharmacist and adjust the dosage accordingly when taking these medications together. This medication carries a risk of abuse and addiction, so it should be taken exactly as prescribed, and any signs of drug abuse should be reported to healthcare professionals immediately.

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, indigestion, erythema, anxiety, dysphoria, dyspnea, orthostatic hypotension, chills, single contraction, gastritis, strange dreams, abnormal thoughts, bronchospasm, increased cough, hiccups, accidental injury, chest pain, facial edema, malaise, sore throat, pain, allergic reaction, drug dependence, mydriasis, tolerance, anaphylactic reaction, neonatal drug withdrawal syndrome, migraine, syncope, vasodilation, palpitations, ventricular tachycardia, dysphagia, belching, abdominal bloating, gastrointestinal disorders, increased appetite, stomatitis, biliary pain, intestinal obstruction, caries, bile stasis, increased liver enzymes, lymph node disorders, dehydration, edema, hyponatremia, peripheral edema, inappropriate antidiuretic hormone secretion syndrome, thirst, abnormal gait, agitation, forgetfulness, depersonalization, depression, emotional lability, hallucinations, hyperactivity, sensory impairment, hypotonia, malaise, paresthesia, seizures, speech disturbances, stupor, tinnitus, tremor, withdrawal symptoms with or without seizures, convulsions, tension headache, involuntary muscle contractions, aggression, hyperalgesia, increased cough, pharyngitis, voice alteration, central sleep apnea syndrome, dry skin, snowfall, urticaria, visual disturbances, taste distortion, amenorrhea, decreased libido, urination disorders, hematuria, erectile dysfunction, polyuria, urinary retention, urination disorders, male hypogonadism, choking, nausea, reflux, throat obstruction

This medication should be stored in a container that blocks light and air, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance

Yellow round extended-release film-coated tablets

Package unit

56 tablets (14 tablets/PTP x 4)