Medication info
Tajinseobangjeong 20/10mg

Tajinseobangjeong 20/10mg

Prescription medicationTabletOral
Ingredient · strength
Oxycodone Hydrochloride›21mg / 1 tabletNaloxone Hydrochloride Dihydrate›10.9mg / 1 tablet
Manufacturer / importer
Mundipharma Korea Ltd.,
Appearance
Pink, double-convex, rectangular film-coated extended-release tablet
Packaging
56 tablets (14 tablets/PTP packaging x 4)
Approval status
Active

MFDS item code 200904276 · Approved 2009.06.18 · Insurance code 678000190

Summary

Main use
Relief of moderate to severe pain requiring opioid analgesics
Who takes it
Adults · Children
Adult dose
Patients who have not previously taken opioid analgesics: The usual initial dose for these patients is 1 tablet of Targin prolonged-release tablets 10mg/5mg every 12 hours. If taking non-opioid analgesics [aspirin, acetaminophen, or nonsteroidal anti-inflammatory drugs], they may be continued. If the current non-opioid analgesic is discontinued, the dose of this medicine may need to be increased sooner. Targin prolonged-release tablets 5mg/2.5mg are used to initiate opioid analgesic treatment or adjust the individual dose. In patients currently receiving opioid analgesics, treatment may be initiated at a higher dose depending on their previous opioid analgesic exposure. The maximum daily dose of this medicine is limited to 160mg/80mg (oxycodone hydrochloride 160mg + naloxone hydrochloride 80mg). The maximum daily dose may be used in patients with experience of being stably maintained on a daily dose of Targin prolonged-release tablets and who require a dose increase. For patients who require a higher dose, supplemental prolonged-release oxycodone at the same dosing intervals should be considered, taking into account that the maximum daily dose of prolonged-release oxycodone is 400mg. Oxycodone doses exceeding 40 mg per dose or 80 mg per day should be used only in patients tolerant to opioid analgesics, and sufficient caution should be exercised in such cases. Patients should be informed that use of oxycodone exceeding 40 mg per dose or 80 mg per day in patients who are not tolerant to opioid analgesics may cause serious adverse reactions, including death. The single dose of 'rescue medication' used to treat breakthrough pain should be approximately 1/6 of the daily oxycodone dose. If more than 2 doses of 'rescue medication' are needed per day, this generally indicates that the dose of this medicine needs to be increased. Adjust the dose every 1∼2 days using 5mg/2.5mg or 10mg/5mg (twice daily) until a stable dose is reached. This medicine is administered twice daily at a fixed dose and fixed dosing interval (every 12 hours). For most patients, symmetric dosing at fixed intervals (the same dose in the morning and evening) is appropriate, although asymmetric dosing may be beneficial for some patients depending on their pain pattern. In general, select the lowest dose that provides analgesia. For the treatment of non-cancer pain, a daily dose of oxycodone hydrochloride/naloxone hydrochloride up to 40/20mg (this medicine 20/10mg twice daily) is generally sufficient, but higher doses may be needed. This medicine is taken twice daily at the prescribed times and doses. Older adults: As in adults, the dose in older adults should be adjusted according to pain intensity and patient sensitivity. Patients with hepatic impairment: Use caution when administering this medicine to patients with mild hepatic impairment. Do not administer this medicine to patients with moderate to severe hepatic impairment. Patients with renal impairment: Use caution when administering this medicine to patients with renal impairment.
Child dose
Children under 18 years of age: The safety and efficacy of this medicine have not been established in children under 18 years of age; therefore, its use in children under 18 years of age is not recommended.

Ingredients

Importer
Mundipharma Korea Ltd.,

Efficacy & effects

Relief of moderate to severe pain requiring opioid analgesics

  • Moderate pain
  • severe pain
View approved original text

Narcotic analgesics are used effectively to relieve various types of moderate to severe pain. For example, they are suitable for strong pain management such as postoperative pain or pain due to cancer. This medication plays an important role in improving patients' quality of life by reducing the intensity of pain. Therefore, for patients experiencing severe pain, narcotic analgesics provide safe and rapid pain relief, thereby enhancing the therapeutic effect. This medication is used for the treatment of moderate to severe pain.

How to take

Adult dose

Patients who have not previously taken opioid analgesics: The usual initial dose for these patients is 1 tablet of Targin prolonged-release tablets 10mg/5mg every 12 hours. If taking non-opioid analgesics [aspirin, acetaminophen, or nonsteroidal anti-inflammatory drugs], they may be continued. If the current non-opioid analgesic is discontinued, the dose of this medicine may need to be increased sooner. Targin prolonged-release tablets 5mg/2.5mg are used to initiate opioid analgesic treatment or adjust the individual dose. In patients currently receiving opioid analgesics, treatment may be initiated at a higher dose depending on their previous opioid analgesic exposure. The maximum daily dose of this medicine is limited to 160mg/80mg (oxycodone hydrochloride 160mg + naloxone hydrochloride 80mg). The maximum daily dose may be used in patients with experience of being stably maintained on a daily dose of Targin prolonged-release tablets and who require a dose increase. For patients who require a higher dose, supplemental prolonged-release oxycodone at the same dosing intervals should be considered, taking into account that the maximum daily dose of prolonged-release oxycodone is 400mg. Oxycodone doses exceeding 40 mg per dose or 80 mg per day should be used only in patients tolerant to opioid analgesics, and sufficient caution should be exercised in such cases. Patients should be informed that use of oxycodone exceeding 40 mg per dose or 80 mg per day in patients who are not tolerant to opioid analgesics may cause serious adverse reactions, including death. The single dose of 'rescue medication' used to treat breakthrough pain should be approximately 1/6 of the daily oxycodone dose. If more than 2 doses of 'rescue medication' are needed per day, this generally indicates that the dose of this medicine needs to be increased. Adjust the dose every 1∼2 days using 5mg/2.5mg or 10mg/5mg (twice daily) until a stable dose is reached. This medicine is administered twice daily at a fixed dose and fixed dosing interval (every 12 hours). For most patients, symmetric dosing at fixed intervals (the same dose in the morning and evening) is appropriate, although asymmetric dosing may be beneficial for some patients depending on their pain pattern. In general, select the lowest dose that provides analgesia. For the treatment of non-cancer pain, a daily dose of oxycodone hydrochloride/naloxone hydrochloride up to 40/20mg (this medicine 20/10mg twice daily) is generally sufficient, but higher doses may be needed. This medicine is taken twice daily at the prescribed times and doses. Older adults: As in adults, the dose in older adults should be adjusted according to pain intensity and patient sensitivity. Patients with hepatic impairment: Use caution when administering this medicine to patients with mild hepatic impairment. Do not administer this medicine to patients with moderate to severe hepatic impairment. Patients with renal impairment: Use caution when administering this medicine to patients with renal impairment.

Child dose

Children under 18 years of age: The safety and efficacy of this medicine have not been established in children under 18 years of age; therefore, its use in children under 18 years of age is not recommended.

Precautions

This medication has the characteristic of gradually releasing the active ingredients, so it must be swallowed whole and not chewed or crushed to act safely. If the tablet is chewed or crushed, the medication may be released quickly, leading to dangerous side effects. This drug is not suitable for treating withdrawal symptoms and carries a serious risk of respiratory depression. Care must be taken to prevent drug abuse and addiction, especially when taken with other central nervous system depressants or alcohol, which can lead to severe sedation, respiratory depression, coma, or even death. This medication should not be administered to specific patients, such as those with hypersensitivity to the main ingredients, severe respiratory diseases, severe liver impairment, pregnant or breastfeeding women. Patients with impaired respiratory function, head injuries, hypotension, the elderly, and those with a history of alcohol addiction must use this medication with more caution, adjusting the dosage and closely monitoring their condition. Prolonged use may lead to drug tolerance, and sudden cessation may induce withdrawal symptoms, so it is important to taper off gradually. It is advisable to avoid driving or operating machinery while taking this medication, as drowsiness or sudden sleep attacks may occur. Additionally, this medication may be affected by liver and kidney function, so patients with compromised liver or kidney function may require dose adjustments. Pregnant or breastfeeding women should not take this medication as it may have serious effects on the fetus or newborn. This medication can interact with other drugs; caution is especially needed when taken with central nervous system depressants, antidepressants, antibiotics, antifungals, and certain antivirals. In case of overdose, there is a risk of respiratory depression, coma, and death, so the prescribed dosage must be strictly followed, and any abnormal symptoms should be reported to medical personnel immediately. Finally, this drug is not recommended for children, and the prescribed dosage and administration must be strictly adhered to, storing it out of reach of children.

Side effects

Hypersensitivity, decreased appetite, insomnia, abnormal thoughts, anxiety, confusion, depression, decreased libido, irritability, restlessness, drug dependence, euphoria, hallucinations, nightmares, aggression, dizziness, headache, drowsiness, convulsions, attention disorders, taste disturbances, speech disorders, syncope, tremors, somnolence, sensory impairment, sedation, visual disturbances, vertigo, angina, palpitations, tachycardia, facial flushing, blood pressure reduction, blood pressure elevation, respiratory disorders, runny nose, cough, yawning, respiratory depression, central sleep apnea syndrome, abdominal pain, constipation, diarrhea, dry mouth, indigestion, vomiting, nausea, bloating, abdominal distention, belching, increased liver enzymes, biliary colic, itching, rash, hyperhidrosis, muscle spasms, muscle cramps, myalgia, urgency in urination, urinary retention, erectile dysfunction, weakness, fatigue, chest pain, chills, drug withdrawal syndrome, apathy, pain, peripheral edema, thirst, weight loss, weight gain, trauma-related injury, herpes simplex, anaphylactic reaction, dehydration, increased appetite, mood swings, personality changes, decreased activity, hyperactivity, agitation, perceptual disturbances, impaired concentration, migraine, hypertonia, involuntary muscle contractions, sensory decrease, sensory disturbances, hyperalgesia, miosis, auditory impairment, vasodilation, hiccups, dysphagia, intestinal obstruction, gastritis, bloody stools, gingival bleeding, dental caries, biliary stasis, sphincter of Oddi dysfunction, dry skin, urticaria, dysuria, hypogonadism, amenorrhea, edema, drug tolerance, neonatal drug withdrawal syndrome, accidental injury, chest pain, facial edema, discomfort, neck pain, allergic reaction, mydriasis, tolerance, migraine, syncope, ST depression, supraventricular tachycardia, dysphagia, abdominal bloating, increased appetite, biliary pain, lymphadenopathy, dehydration, edema, hyponatremia, peripheral edema, inappropriate secretion of antidiuretic hormone syndrome, thirst, abnormal gait, excitation, forgetfulness, depersonalization, depression, emotional instability, hyperactivity, hypotonia, discomfort, seizures, confusion, tinnitus, withdrawal symptoms either with or without seizures, anxiety, involuntary muscle contractions, voice changes, dry skin, swerve, urticaria, visual disturbances, dysgeusia, amenorrhea, decreased libido, urinary disorders, hematuria, polyuria, urinary retention, urinary disorders

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a special container to avoid exposure to light and air, in a cool place, i.e., at a temperature below 25 degrees Celsius. This will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pink, double-convex, rectangular film-coated extended-release tablet

Package unit

56 tablets (14 tablets/PTP packaging x 4)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.