Tajinsen Extended-release Tablets 5/2.5mg

Adult dose

Patients who have not previously taken opioid analgesics: The usual initial dose for these patients is one Targin Prolonged-Release Tablet 10mg/5mg every 12 hours. Targin Prolonged-Release Tablet 5mg/2.5mg is used when initiating opioid analgesic therapy or adjusting an individual's dose. In patients receiving opioid analgesics, treatment may be initiated at a higher dose depending on their previous opioid analgesic experience. The maximum daily dose of this medicine is limited to 160mg/80mg (oxycodone hydrochloride 160mg + naloxone hydrochloride 80mg). For patients who require a higher dose, consider supplementing with prolonged-release oxycodone at the same dosing intervals, 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 the “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 using 5mg/2.5mg or 10mg/5mg (twice daily) every 1∼2 days until a stable dose is reached. This medicine is administered twice daily at a fixed dose and at fixed intervals (every 12 hours). For the treatment of non-cancer pain, a dose up to oxycodone hydrochloride/naloxone hydrochloride 40/20mg per day (this medicine 20/10mg twice daily) is generally sufficient, although a higher dose may be required. This medicine is taken twice daily at the prescribed times and doses. As in adults, adjust the dose in elderly patients according to pain intensity and patient sensitivity. Use this medicine with caution in patients with mild hepatic impairment. This medicine must not be administered to patients with moderate to severe hepatic impairment. Use this medicine with caution in patients with renal impairment.

Child dose

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

This medication is in an extended-release formulation and should be swallowed whole; do not chew or crush the tablet. Chewing or crushing the tablet can lead to rapid drug release, increasing the risk of overdose. This drug is not suitable for treating withdrawal symptoms, and respiratory depression is a major risk. Caution is needed to prevent drug abuse, and serious side effects may occur when taken with sedatives or alcohol. This medication should not be administered to patients with certain respiratory diseases, liver dysfunction, or who are pregnant or breastfeeding. Caution should be observed in patients with compromised respiratory function, head injury, or hypotension, and their symptoms should be closely monitored. Long-term use may lead to tolerance or physical dependence, and abrupt discontinuation may result in withdrawal symptoms, necessitating a gradual tapering of the dosage. Drowsiness or sedation may occur when driving or operating machinery, so caution is advised. This drug increases the risk of respiratory depression and coma when combined with other central nervous system depressants, so dosage should be reduced and patient conditions closely monitored during co-administration. Pregnant or breastfeeding women should not use this drug as it may adversely affect the fetus or newborn. Elderly patients may have slower drug metabolism, requiring reduced starting doses and careful administration. Overdose may lead to serious symptoms such as respiratory depression, coma, and hypotension, necessitating immediate medical attention. This medication is not recommended for children and should be stored out of reach of children for safety. Common side effects of this drug may include constipation, nausea, drowsiness, dizziness, and itching. Dose adjustments should be made according to the physician's instructions, and any abnormal symptoms should be promptly discussed.

Hypersensitivity, decreased appetite, insomnia, abnormal thoughts, anxiety, confusion, depression, decreased libido, irritability, restlessness, drug dependence, relief, hallucinations, nightmares, aggression, dizziness, headache, drowsiness, seizures, attention deficit disorder, taste disorder, speech disorder, syncope, tremors, hypersomnia, sensory disturbance, sedation, visual impairment, vertigo, angina, palpitations, tachycardia, facial flushing, hypotension, hypertension, respiratory disorders, runny nose, cough, yawning, respiratory depression, central sleep apnea syndrome, abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, vomiting, nausea, bloating, abdominal distension, belching, elevated liver enzymes, biliary colic, itching, rash, excessive sweating, muscle spasms, muscle cramp, myalgia, urinary urgency, urinary retention, erectile dysfunction, weakness, fatigue, chest pain, chills, drug withdrawal syndrome, weariness, pain, peripheral edema, thirst, weight loss, weight gain, injury due to accident, herpes simplex, anaphylactic reaction, dehydration, increased appetite, mood swings, personality change, decreased activity, hyperactivity, agitation, perceptual disturbance, impaired concentration, migraine, hypermuscle tone, involuntary muscle contraction, sensory decrease, sensory abnormality, hyperalgesia, miosis, hearing impairment, vasodilation, dyspnea, hiccups, dysphagia, intestinal obstruction, gastritis, blood in stool, gum bleeding, cavities, bile duct stasis, dysfunction of the Oddi sphincter, dry skin, urticaria, difficulty urinating, hypogonadism, amenorrhea, edema, drug tolerance, neonatal drug withdrawal syndrome, accidental injury, chest pain, facial edema, malaise, throat pain, allergic reaction, mydriasis, tolerance, migraine, syncope, ST depression, supraventricular tachycardia, dysphagia, abdominal fullness, increased appetite, biliary pain, lymph node disorders, dehydration, edema, hyponatremia, peripheral edema, inappropriate antidiuretic hormone secretion syndrome, thirst, abnormal gait, excitement, amnesia, depersonalization, depression, emotional instability, hyperactivity, hypotonicity, malaise, seizures, confusion, tinnitus, withdrawal symptoms with or without seizures, neuromuscular tension, involuntary muscle contraction, increased coughing, pharyngitis, dysphonia, dry skin, snowflakes, urticaria, visual disturbances, taste distortion, amenorrhea, decreased libido, urinary disorders, hematuria, polyuria, urinary retention, urinary disorders

This medication is sensitive to light and should be stored in a container that effectively blocks light. It is also important to store it at a cool temperature below 25 degrees Celsius to maintain the drug's efficacy.

Appearance

Blue, bilaterally convex rectangular film-coated extended-release tablets

Package unit

56 tablets (14 tablets/PTP packaging x 4)