Entiducetin Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This drug is administered at a dose of 60mg once daily, without regard to meals. In some patients, treatment may be initiated at 30mg once daily for 1 week to allow the patient to adjust to the medication, 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 drug has not been clearly established. Maintenance treatment In general, the therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms have improved, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reassess the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial treatment This drug is administered at a dose of 60mg once daily, without regard to meals. In some patients, treatment may be initiated at 30mg once daily for 1 week to allow the patient to adjust to the medication, 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 drug for generalized anxiety disorder, i.e., for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend treatment with this drug should periodically reassess the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, without regard to meals. It is safe and effective at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. For patients whose tolerability is a concern, 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 the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, a 1-year open-label safety study was conducted. 4) Treatment of fibromyalgia Initial treatment The recommended dose of this drug is 60mg once daily. To allow the patient to adjust to the medication, treatment should be initiated at 30mg once daily for 1 week and then increased to 60mg once daily. Some patients may respond to the starting dose. No evidence of additional benefit has been observed at doses exceeding 60mg/day, even in patients who do not respond to 60mg, and administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is considered a chronic condition. In placebo-controlled trials of treatment for fibromyalgia, the efficacy of this drug was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term trials exceeding 3 months; however, the need to continue treatment should be determined based on each patient's response. 5) Treatment of osteoarthritis pain with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial treatment The recommended dose of this drug is 60mg once daily. To allow the patient to adjust to the medication, administer 30mg once daily for 1 week, then increase 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 drug 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 medications, 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 drug 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 drug should not be administered to patients with end-stage renal disease (requiring dialysis) or severe renal impairment (creatinine clearance less than 30mL/min). 6. Discontinuation of treatment When discontinuing this drug, 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, gradually reducing the dose beginning 2 weeks before discontinuation is recommended to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take the medication 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 drug, an interval of at least 14 days should be allowed. Conversely, if initiating an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days must have elapsed after discontinuing this drug. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 who is already receiving this drug. 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Children's dosage

Children and adolescents under 18 years of age: Because of concerns about safety and efficacy, 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 medication is primarily used to treat depression and psychiatric disorders, and there is an increased risk of suicidal thoughts or behavior particularly in young adults aged 18 to 24, thus careful assessment and ongoing observation by a healthcare provider are needed. During the course of treatment, there may be changes in mental state, such as abnormal behavior like aggression and anger, thus both patients and their families or caregivers should closely monitor for these changes. Serotonin syndrome, a serious side effect, may occur, so caution is particularly necessary when used in conjunction with other drugs affecting serotonin. If symptoms arise, medication should be discontinued immediately and medical consultation sought. Patients with impaired liver function or severe renal impairment, uncontrolled hypertension, or glaucoma should not take this medication. It should also be avoided in patients with allergies to any components of this medication. Common side effects during treatment include dizziness, drowsiness, nausea, dry mouth, headache, etc., which tend to alleviate over time. Abruptly stopping the medication may cause withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and headache; therefore, the dosage should be gradually reduced according to a physician's instructions when discontinuing. There may be an increase in blood pressure or heart rate, so it is important for patients with hypertension or heart conditions to regularly monitor their blood pressure. Patients with a tendency to bleed or those taking anticoagulants or medications affecting platelet function may have an increased risk of bleeding. Women who are pregnant or breastfeeding should consult a physician before taking this medication, especially late in pregnancy, as there can be side effects in neonates. This medication is not recommended for children and adolescents under 18 due to insufficient evidence of safety and efficacy. In elderly patients, specific dosage adjustments are not necessary, but careful monitoring is needed as responses to medication may vary. Overdose may lead to serious symptoms such as coma, seizures, serotonin syndrome, thus immediate medical attention should be sought.

nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, suicidal thoughts, bruxism, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremor, sensory disturbances, dystonia, akathisia, neurosensitivity, attention deficit, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, complex arrhythmia, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myoclonus, jaw-opening disorders, dysuria, urinary frequency, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, hyperkalemia, increased serum cholesterol, musculoskeletal pain, muscle spasms, migraine, altered taste, insomnia, anxiety, sleep disorders, abnormal dreams, orgasm dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, pruritus, facial flushing, acute pancreatitis, erythema multiforme, extrapyramidal disorder, incontinence, vasculitis, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reaction, microscopic colitis, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, dysphagia, dry skin, decreased blood pressure, limb pain, onychomycosis, vision loss, yawning, worsening depression, edema, gastric ulcer, head discomfort, burning sensation, intellectual disability, depression, elevated bilirubin levels, drug intoxication, hiccups, respiratory distress, akathisia, suicide attempt, overdose, suicidal thoughts, suicidal behavior, coma, seizures

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a yellow-green lower part, containing white to light brown enteric-coated spherical granules.

Package unit

28 capsules/PPT