Entiduseitin Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow them to adjust to the medicine, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses exceeding 60mg per day, and the dose-response relationship for the efficacy of this medicine has not been clearly established. Maintenance treatment In general, a response to antidepressant treatment begins to appear after 2~4 weeks. Even after depressive symptoms have improved, continued medication use for several months is recommended to prevent relapse. The physician should periodically reevaluate the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow them to adjust to the medicine, and then increased to 60mg once daily. Efficacy has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose of more than 60mg once daily is selected, the dose should be increased in increments of 30mg once daily. The safety of doses exceeding 120mg once daily has not been adequately evaluated. Maintenance treatment Generalized anxiety disorder is generally considered a chronic condition. The efficacy of long-term use of this medicine for generalized anxiety disorder, that is, for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend treatment with this medicine should periodically reevaluate the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medicine is administered at 60mg once daily, with or without food. It is safe and effective at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability was reduced at higher doses. For patients with concerns about tolerability, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment Because diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this medicine should be assessed individually. Although the efficacy of this medicine when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials, a 1-year open-label safety study was conducted. 4) Treatment of fibromyalgia Initial treatment The recommended dose of this medicine is 60mg once daily. To allow the patient to adjust to the medicine, treatment should be started at 30mg once daily for 1 week and then increased to 60mg once daily. Some patients may respond to the starting dose. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses exceeding 60mg/day, and administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is considered a chronic condition. The efficacy of this medicine in placebo-controlled trials for the treatment of fibromyalgia was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term trials exceeding 3 months; however, the need for continued treatment should be determined based on each patient's response. 5) Treatment of osteoarthritis pain inadequately responsive to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial treatment The recommended dose of this medicine is 60mg once daily. To allow the patient to adjust to the medicine, administer 30mg once daily for 1 week, then increase the dose to 60mg once daily. Administration of doses exceeding 60mg per day to patients who do not respond to the recommended dose (60mg/day) provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this medicine when administered for more than 13 weeks for the treatment of osteoarthritis pain have not been studied. 2. Elderly patients Dose adjustment based on age is not recommended. However, as with other medicines, caution is required during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. 4. Patients with hepatic impairment Because hepatic impairment may occur, this medicine should not be used in patients with liver disease. 5. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance 30~ 80mL/min). This medicine should not be administered to patients with end-stage renal disease (patients requiring dialysis) or severe renal impairment (creatinine clearance less than 30mL/min). 6. Discontinuation of treatment When discontinuing this medicine, gradual dose reduction over at least 1~2 weeks is recommended, if possible, rather than abrupt discontinuation. If treatment is discontinued after more than 1 week of medication use, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take the medicine every other day. However, the exact method should be determined based on the individual patient's circumstances, including the duration of treatment and the dose being taken at the time of discontinuation. 7. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days should have elapsed after discontinuation of this medicine. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Children's dosage

This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medicine for indications other than major depressive disorder have not been studied.

This drug is primarily used to treat psychiatric disorders associated with depression. While taking this medication, there may be an increase in thoughts or behaviors related to suicide, especially in young patients aged 18 to 24, necessitating careful judgment and continuous observation by healthcare professionals. Additionally, this drug can cause serious side effects such as serotonin syndrome, especially when taken with other serotonergic agents. If there are sudden changes in mental status, or symptoms such as aggression, anxiety, or hallucinations, it is essential to consult a healthcare professional immediately. Co-administration with certain medications, particularly MAO inhibitors, is highly dangerous and should never be done. Patients with severely impaired liver or kidney function, uncontrolled hypertension, and certain glaucoma conditions are advised not to take this medication. Common side effects may include nausea, headache, dry mouth, drowsiness, and dizziness, mostly occurring during the initial stages of treatment and resolving over time. Abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it is crucial to taper off the dosage gradually under medical supervision. Patients with hypertension or heart disease should have regular monitoring of blood pressure and heart rate as blood pressure may rise or heart rate may increase. Patients with a tendency to bleed or those taking anticoagulants should be cautious as the risk of bleeding may increase. Women who are pregnant or nursing should consult a doctor before taking this medication, especially during late pregnancy, as it may affect the newborn; careful judgment is necessary. Safety and efficacy in children and adolescents have not been established, and it should not be administered to those under 18 years of age. Care should be taken when driving or operating hazardous machinery as drowsiness or dizziness may occur. During treatment with this drug, there is a possibility of interactions with other medications, so it is important to inform healthcare professionals about all medications being taken. In the case of overdose, there is a risk of coma, seizures, and serotonin syndrome; immediate emergency treatment is necessary. This medication should be kept out of reach of children and stored in the original container to maintain quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, tics, akathisia, nervousness, attention deficit, taste disturbances, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, pupillary dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, nasal bleeding, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myopathy, jaw clenching disorder, dysuria, frequency of urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculation disorders, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, fatigue, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, elevated serum potassium, increased serum cholesterol, musculoskeletal pain, migraine, taste disturbance, nightmares, orgasm dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, pruritus, facial flushing, elevated serum cholesterol, dehydration, hyperlipidemia, dyslipidemia, taste disorders, concentration disorders, hyperkinetic disorders, speech disorders, abnormal dreams, loss of direction, confusion, severe mood swings, suicide attempts, urination disorders, urinary urgency, nocturnal enuresis, polyuria, abnormal urinary odor, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, erythema multiforme, incontinence, vasculitis, microscopic colitis, seizures upon discontinuation of treatment, supraventricular arrhythmia, opening disorder, blood pressure decrease, onychomycosis, exacerbation of depression, edema, gastric ulcer, head discomfort, burning sensation, mental retardation, intoxication state, hiccups, dyspnea

Store this medication in a well-sealed container to prevent air and moisture from entering. It is best to keep it in a cool place between 15 to 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a white lower part containing round enteric-coated granules that are white to light brown.

Package unit

28 capsules/PTP