NUSHINTA Sustained Release Tablet 50 mg (Tapentadol Hydrochloride)

Adult dose

This medicine should be prescribed by a specialist with extensive knowledge of chronic pain management using opioid analgesics. As with many other analgesics that act on the central nervous system, the dosage should be individualized according to the severity of the pain being treated, previous treatment experience, and the ability to monitor the patient. Take this medicine whole; do not chew or crush it. If chewed or crushed, the medicine may be released rapidly and an amount that could potentially cause toxicity may be absorbed. Swallow one tablet at a time. As soon as it is placed in the mouth, swallow it completely with plenty of water. Take this medicine twice daily, approximately 12 hours apart, with or without food. The outer shell of this medicine may not be completely digested and may be found in the patient's stool; however, this is not clinically relevant because the active ingredient has already been absorbed into the body. 1. Initiation of treatment 1) Patients not currently taking opioid analgesics Initiate treatment with this medicine at 50mg twice daily. 2) Patients currently taking opioid analgesics When switching from an opioid analgesic to this medicine and determining the initial dose, consider the properties and potency of the previous medicine and the average daily dose. Discontinue all other extended-release/long-acting opioid analgesics before administering this medicine. 2. Titration and maintenance After initiating treatment, individually titrate the dose under close supervision by the prescriber to achieve adequate analgesia while minimizing adverse effects. Clinical trial experience indicates that increasing the dose by 50mg at 3-day intervals while maintaining twice-daily administration is an appropriate titration method. This medicine is not recommended at daily doses exceeding 500mg, as such doses have not been studied. 3. Discontinuation of treatment Abrupt discontinuation of treatment with this medicine may cause withdrawal symptoms. For patients who no longer require treatment with this medicine, gradual dose reduction is recommended to prevent withdrawal symptoms. 4. Patients with renal impairment No dose adjustment is required in patients with mild or moderate renal impairment. Use of this medicine is not recommended in patients with severe renal impairment because controlled clinical trials evaluating efficacy have not been conducted in these patients. 5. Patients with hepatic impairment No dose adjustment is required in patients with mild hepatic impairment. Administer this medicine with caution to patients with moderate hepatic impairment. Start treatment in these patients with 50mg of this medicine, and do not administer it more often than once every 24 hours. Thereafter, shorten or lengthen the dosing interval as tolerated to maintain analgesic efficacy. Use of this medicine is not recommended in patients with severe hepatic impairment because it has not been studied in these patients. 6. Older patients (65 years and older) In general, the recommended dose for older patients with normal renal and hepatic function is the same as for younger adults with normal renal and hepatic function. Since older patients are more likely to have reduced renal and hepatic function, use caution when selecting the dose in accordance with the recommendations.

Child dose

Use is not recommended in patients under 18 years of age.

This medicine can lead to opioid use disorder if used repeatedly, so caution is necessary. Abuse or intentional misuse can result in overdose and serious side effects. Patients with a history of substance use disorder or mental health issues may be at greater risk, so consultation with a professional is recommended. High doses may cause respiratory depression, thus patients with respiratory function issues should use it cautiously. Prolonged use during pregnancy may lead to withdrawal syndrome in newborns, so caution is required. This medicine, when taken with central nervous system depressants or alcohol, increases the risk of severe sedation, respiratory depression, coma, and death. Therefore, it should be used at minimum doses for a short duration when used in combination with such substances, and patients should be closely monitored. Patients with allergies to this medicine or its ingredients, severe respiratory depression, acute bronchial asthma, or paralytic ileus should not use this medication. Patients with impaired kidney or liver function, hypotension, biliary disease, or epilepsy should be administered with caution, and pregnant and breastfeeding women should also exercise caution. Side effects such as dizziness, drowsiness, constipation, headache, nausea, etc. may frequently occur during the use of this medicine. In addition, severe symptoms such as respiratory distress, hypotension, mental disorders, seizures, and allergic reactions may arise; if any abnormal symptoms occur, immediate consultation with a physician is required. Caution is advised when driving or operating machinery as this medication may affect the central nervous system. There are many drug interactions with this medicine, particularly when taken with benzodiazepines, central nervous system depressants, MAO inhibitors, antidepressants, etc.; consultation with a professional is necessary in such cases. During pregnancy, the risks and benefits for the fetus should be carefully considered, and if breastfeeding, discontinuation of nursing or the medication is recommended. In the case of overdose, serious symptoms such as respiratory depression, consciousness disturbances, seizures, etc. may occur, so immediate medical treatment is required. Management of overdose includes the administration of opioid antagonists as well as airway management and adjunctive respiratory support.

Nausea, dizziness, constipation, headache, drowsiness, drug hypersensitivity, decreased appetite, weight loss, sleep disturbances, anxiety, depression, irritability, restlessness, strange dreams, cognitive impairment, disorientation, agitation, confusion, sense of relief, panic attack, drug dependence, unusual thoughts, delirium, involuntary muscle contraction, tremor, attention deficit, perceptual distortion, sensory loss, balance disorder, sedation, syncope, memory impairment, mental disturbances, decreased level of consciousness, speech disorder, coordination abnormalities, generalized syncope, convulsions, visual impairment, increased heart rate, decreased heart rate, palpitations, flushing, decreased blood pressure, dyspnea, respiratory depression, vomiting, diarrhea, dyspepsia, abdominal discomfort, pruritus, hyperhidrosis, rash, urticaria, urinary hesitancy, frequent urination, sexual dysfunction, fatigue, mucosal dryness, weakness, feeling of temperature change, edema, drug withdrawal syndrome, irritability, strange feelings, a sensation of being intoxicated, relaxation, angioedema, anaphylaxis, anaphylactic shock, suicidal ideation, ascites, abdominal pain, abdominal distension, hematemesis, pneumonia, bacteremia, sepsis, pulmonary sepsis, weakness, pulmonary inflammation, hemoptysis, pleural effusion, arrhythmia, anxiety, completed suicide, benign, malignant, and unspecified neoplasms, esophageal pain, fever, cough, anemia, lumbar pain, peripheral neuropathy, abdominal pain, odynophagia, stomatitis, epigastric pain, intestinal obstruction, passage of blood in stool, oral discomfort, dysphagia, gastroesophageal reflux disease, dry mouth, rectal pain, anal fissure, melena, upper respiratory infection, urinary tract infection, infectious cholecystitis, oral candidiasis, acute pyelonephritis, bronchitis, herpes simplex, cholangitis, shingles, bronchiolitis, nasopharyngitis, varicella-zoster virus infection, urethritis, gastroenteritis, pharyngitis, stomal infection, pericoronitis, dental pulpitis, catheter site infection, peripheral edema, mucosal inflammation, chest discomfort, facial swelling, pain, productive cough, rhinorrhea, oropharyngeal pain, bronchial obstruction, pneumothorax, hiccups, wheezing, pulmonary edema, febrile neutropenia, pancytopenia, eosinophilia, hypoalbuminemia, hypokalemia, hyperkalemia, decreased appetite, hypoglycemia, diabetes, diabetic ketoacidosis, glucose tolerance disorder, steroid-induced diabetes, cachexia, hyponatremia, hypomagnesemia, hypophosphatemia, hypocalcemia, flank pain, bone pain, musculoskeletal pain, tendinitis, cervical pain, arthralgia, muscle weakness, limb pain, spinal stenosis, cancer-related pain, peripheral sensory neuropathy, sleep seizures, decreased neutrophil count, decreased platelet count, elevated liver function tests, increased aspartate aminotransferase, increased alanine aminotransferase, increased serum alkaline phosphatase, abnormal chest X-ray, alopecia, palmoplantar erythrodysesthesia syndrome, papules, diaphoresis, skin lesions, dermatitis, erythema, orthostatic hypotension, hypertension, peripheral circulatory failure, peripheral ischemia, deep vein thrombosis, depression, panic disorder, hallucinations, non-infectious cystitis, dysuria, hydronephrosis, urgency, eye inflammation, diplopia, pelvic fracture, trauma-related pain, hearing loss, pelvic pain, colonic diverticulitis, miosis, vomiting, cardiovascular collapse, severe consciousness disorder leading to maximal stupor, convulsion, severe respiratory arrest

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White rectangular sustained release tablet

Package unit

30 tablets (10 tablets * 3 PTP) / box