New Syntax Extended Release Tablets 150 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

Pediatric patients (under 18 years of age) Safety and efficacy have not been established in pediatric patients; therefore, use is not recommended in patients under 18 years of age.

This medication may develop tolerance if used repeatedly, and there is a risk of opioid use disorder. Caution should be exercised as misuse or intentional improper use can lead to overdose or, in severe cases, death. People with a history of alcohol or mental health issues may be at higher risk, so it is important to monitor for drug-seeking behavior or unusual signs during use. This medication can suppress respiration at high doses, so it should be used cautiously in patients with compromised respiratory function or high intracranial pressure. Long-term use during pregnancy may result in neonatal opioid withdrawal syndrome, so pregnant individuals must consult a doctor before taking it. Additionally, taking this medication alongside narcotics, benzodiazepines, or alcohol can lead to severe sedation, respiratory depression, coma, or even death; therefore, minimal dosing for a short duration should be employed when combining such medications, and the patient's condition must be monitored closely. Patients with hypersensitivity to this drug, severe respiratory depression, acute bronchial asthma, paralytic ileus, acute intoxication, or those taking or recently taken MAO inhibitors should not use this drug. Patients with severe renal or liver impairment, hypotension, biliary disease, a history of seizures, pregnant individuals, and nursing mothers should use this drug with caution and, if necessary, under strict supervision by a physician. Common side effects include nausea, dizziness, constipation, headache, drowsiness, sleep disturbances, anxiety, depressed mood, nervousness, restlessness, unusual dreams, cognitive impairment, disorientation, agitation, confusion, panic attacks, drug dependence, unusual thoughts, delirium, involuntary muscle rigidity, tremors, attention disorders, perceptual disturbances, sensory loss, balance disorders, sedation, fainting, memory issues, psychosis, and altered consciousness levels; rare occurrences can include severe allergic reactions or mental disorders, respiratory depression, and more. Discontinuing this drug abruptly can lead to withdrawal symptoms, so dosage adjustments should be made per a doctor’s instructions, and any withdrawal symptoms should be immediately discussed with healthcare professionals. Caution is required when driving or operating machinery, as drowsiness or decreased attention may occur. Finally, in overdose cases, respiratory depression, loss of consciousness, and seizures may occur, necessitating an immediate visit to a medical facility for appropriate treatment, with securing the airway and assisted ventilation being important. Naloxone can mitigate respiratory depression, but continuous monitoring and treatment are necessary.

Nausea, dizziness, constipation, headache, drowsiness, drug hypersensitivity, decreased appetite, weight loss, sleep disturbances, anxiety, depressed mood, nervousness, restlessness, strange dreams, cognitive impairment, disorientation, agitation, confusion, euphoria, panic attacks, drug dependence, strange thoughts, delirium, involuntary muscle contraction, tremors, attention deficit, perceptual disturbances, sensory loss, balance disorders, sedation, fainting, memory impairment, mental disorders, decreased level of consciousness, speech disturbances, coordination problems, syncope, seizures, visual impairment, increased heart rate, decreased heart rate, palpitations, flushing, decreased blood pressure, dyspnea, respiratory depression, vomiting, diarrhea, indigestion, abdominal discomfort, pruritus, hyperhidrosis, rash, urticaria, urinary hesitancy, frequent urination, sexual dysfunction, fatigue, dry mucous membranes, asthenia, sensation of altered body temperature, edema, drug withdrawal syndrome, irritability, feeling strange, feeling drunk, sense of relaxation, angioedema, anaphylaxis, anaphylactic shock, suicidal ideation, ascites, abdominal pain, abdominal distension, hematemesis, pneumonia, bacteremia, sepsis, pulmonary sepsis, asthenia, fever, multiple organ failure syndrome, pulmonary inflammation, hemoptysis, pleural effusion, bone pain, lower back pain, spinal stenosis, hyponatremia, hypoglycemia, neutropenia, arrhythmia, anxiety, completed suicide, hydronephrosis, pulmonary inflammation, esophageal pain, cough, anemia, peripheral neuropathy, abdominal pain, odynophagia, stomatitis, upper abdominal 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, stoma site infection, peri-crown infection, dental pulpitis, catheter site infection, skin infection, peripheral edema, mucosal inflammation, chest discomfort, facial swelling, pain, moist cough, nasal discharge, oropharyngeal pain, bronchial obstruction, pneumothorax, hiccups, wheezing, pulmonary edema, febrile neutropenia, pancytopenia, eosinophilia, hypoalbuminemia, hypokalemia, hyperkalemia, decreased appetite, diabetes, diabetic ketoacidosis, impaired glucose tolerance, steroid-induced diabetes, cachexia, hypomagnesemia, hypophosphatemia, hypocalcemia, flank pain, musculoskeletal pain, tendinitis, cervical pain, arthralgia, muscle weakness, limb pain, peripheral sensory neuropathy, sleep seizures, hallucinations, alopecia, palmar-plantar erythrodysesthesia syndrome, papules, cold sweat, skin lesions, dermatitis, erythema, orthostatic hypotension, hypertension, peripheral circulatory failure, peripheral ischemia, deep vein thrombosis, non-infectious cystitis, dysuria, urgency, eye inflammation, diplopia, pelvic fracture, trauma-related pain, hearing loss, pelvic pain, colostomy, miosis, vomiting, cardiovascular collapse, consciousness disorder, seizures, respiratory arrest

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, the drug should be kept at room temperature, neither too cold nor too hot, ideally between 1 to 30 degrees Celsius.

Appearance

Pale pink rectangular extended release tablet

Package unit

In-house packaging unit