Eroxetine 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, with or without food. In some patients, treatment may be started 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, 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 the need for continued treatment. 2) Treatment of generalized anxiety disorder Initial treatment This drug 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 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 chosen, it 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 known to be a chronic condition. The efficacy of long-term use of this drug 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 drug should periodically reevaluate the patient to determine the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug 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 decreased at higher doses. Consider starting at a lower dose in patients for whom tolerability is a concern. For patients with renal impairment, which often occurs as 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 assessed individually. Although the efficacy of treatment with this drug 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 drug is 60mg once daily. To allow the patient to adjust to the medication, 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. 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 known to be a chronic condition. The efficacy of this drug 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 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 drugs, 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 in 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 (patients 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 whenever possible, rather than abrupt discontinuation. If treatment is discontinued after more than 1 week of drug therapy, 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 medication every other day. However, the exact method should be determined according to 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 for the treatment of 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, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should 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 treatment for a more urgent psychiatric condition, including hospitalization and 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 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 comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection) or intravenous administration of this drug 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

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

This medication is used for the treatment of depression and psychiatric disorders, and caution is especially needed in young adults aged 18 to 24, as the risk of suicidal thoughts or behaviors may increase. During treatment with this medication, it is necessary for family members or caregivers to carefully monitor for any unusual behavioral changes such as suicidal thoughts, aggression, or anger. Serotonin syndrome, a serious side effect, may occur, which includes symptoms such as changes in mental state, high fever, tremors, seizures, and nausea. If these symptoms appear, immediate consultation with medical personnel is required. Particularly, it is extremely dangerous to take this medication in combination with certain psychiatric treatments such as MAO inhibitors, so they should never be used together. Patients with severely impaired liver or kidney function, uncontrolled hypertension, glaucoma, or certain genetic disorders should not take this medication. Patients with a history of mania, bipolar disorder, epilepsy, or a tendency to bleed, as well as the elderly and dehydrated patients, should be particularly cautious when taking this medication, and it is important to regularly monitor blood pressure and heart condition. Common side effects of this medication include nausea, headache, dry mouth, drowsiness, dizziness, decreased appetite, insomnia, anxiety, decreased libido, anorgasmia, bruxism, sleep disorders, numbness, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, akathisia, irritability, attention deficits, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, blurred vision, dilated pupils, visual disturbances, tinnitus, ear pain, palpitations, tachycardia. Sudden cessation of this medication can cause withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, and nausea, so the dosage should be gradually reduced according to the physician's instructions. Women who are pregnant or breastfeeding should consult a doctor, as taking this medication may pose risks to the fetus or newborn. It is generally recommended not to use this medication in pediatric patients and adolescents under 18 due to established safety and efficacy concerns. Caution should be taken while driving or operating hazardous machinery during treatment, and extra caution should be exercised if taking alcohol or other sedatives simultaneously. In case of overdose, serious symptoms such as coma, seizures, or serotonin syndrome can occur, requiring immediate emergency treatment, as there is no specific antidote for this medication and appropriate symptomatic treatment is necessary in a hospital. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain its quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, 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, myoclonic jerks, akathisia, neuropathic irritability, attention deficit, taste disturbances, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, supraventricular arrhythmias, hypertension, flushing, high blood pressure, 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, hematochezia, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, phototoxic reaction, cold sweat, tendency to bruise easily, Steven-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, opening disorder, dysuria, frequent urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculatory dysfunction, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, fatigue, falls, chest pain, hot/cold sensation, malaise, thirst, abnormal feelings, chills, gait disturbances, weight loss, weight gain, elevated serum creatine phosphokinase, increased serum potassium, elevated serum cholesterol, gastrointestinal bleeding, acute pancreatitis, anaphylaxis, erythema multiforme, urticaria syndrome, skin vasculitis, microscopic colitis, supraventricular arrhythmias, opening disorder, urticaria, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, hypoglycemia, worsening depression, edema, uncomfortable head, burning sensation, mental retardation, drug intoxication, hiccups, dyspnea, akathisia, abnormal dreams, emotional fluctuations, suicide attempt, overdose

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at a cool temperature between 15 and 30 degrees Celsius to maintain its effectiveness.

Appearance

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

Package unit

28 Capsules (14 Capsules/PTP Packaging x 2)