Duloxetine Capsule 30mg (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 initiated at 30mg once daily for 1 week to allow them 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. After depressive symptoms improve, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reevaluate the patient to determine whether continued treatment is needed. 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 initiated at 30mg once daily for 1 week to allow them 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 considered 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 whether continued treatment is needed. 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. For patients with tolerability concerns, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Diabetic peripheral neuropathic pain has a variable course, and pain control is empirical; therefore, the effect of this drug should be evaluated individually. Although the efficacy of this drug 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 drug is 60mg once daily. To allow patients 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. 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. In placebo-controlled trials for the treatment of 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 for continued treatment should be determined based on each patient's response. 5) Treatment of osteoarthritis pain in patients with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial treatment The recommended dose of this drug is 60mg once daily. To allow patients to adjust to the medication, administer 30mg once daily for 1 week, then increase to 60mg once daily. For patients who do not respond to the recommended dose (60mg/day), administration of doses exceeding 60mg per 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. 3. Children and adolescents under 18 years of age This drug should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns about safety and efficacy. The safety and efficacy of this drug for conditions other than major depressive disorder have not been studied. 4. Patients with hepatic impairment This drug should not be used in patients with liver disease, as hepatic impairment may occur. 5. Patients with renal impairment No dose adjustment is needed 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, if possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, gradual dose reduction beginning 2 weeks beforehand is recommended to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or the medication may be taken every other day. However, the precise 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 or to 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 must be allowed. Conversely, when starting an MAO inhibitor to treat 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 start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventions, 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 methylene blue administered by nonintravenous routes (oral tablets or local injection), or with 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

Duloxetine should not be used in the treatment of major depressive disorder in children and adolescents under 18. The safety and efficacy for indications other than major depressive disorder have not been studied.

This medication is used to treat psychiatric disorders related to depression. During treatment with this medication, special monitoring is required for pediatric, adolescent, and young adult patients, particularly those aged 18 to 24, as there may be an increased risk of suicidal thoughts or behavior. Serotonin syndrome, a serious adverse effect, may occur when this medication is taken in conjunction with other medications that have serotonergic activity. This medication should not be administered to patients with certain liver diseases, severe renal impairment, uncontrolled glaucoma, or hypertension. Additionally, patients with hypersensitivity to this medication or those taking certain medications (such as MAO inhibitors) should not use it. Use with caution in patients with manic or bipolar disorders, poor liver or kidney function, bleeding tendencies, and the elderly. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur initially and typically improve with time. Abrupt discontinuation may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, and anxiety, thus it is important to taper the dosage gradually. Regular monitoring of blood pressure and heart rate is required during treatment, especially in patients with hypertension. This medication may increase the risk of bleeding; thus, patients taking anticoagulants or medications that affect platelet function should be cautious of bleeding symptoms. Serious skin reactions may occur; if symptoms such as rashes, blisters, or mucosal damage arise, discontinue the medication and consult a physician immediately. Elderly patients may be more vulnerable to electrolyte disturbances such as hyponatremia, thus careful monitoring for these symptoms is advised. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and it is not recommended during breastfeeding. This medication is not to be used in children and adolescents under 18 years of age as safety and efficacy have not been established. In overdose situations, serious symptoms such as coma, seizures, and serotonin syndrome may occur, thus it is essential to adhere to the prescribed dosage and contact a medical facility immediately in case of overdose. Store this medication out of reach of children, and keep it in its original container to avoid alterations in quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremor, sensory disturbances, myoclonus, restlessness, irritability, attention deficit, dysgeusia, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, akathisia, extrapyramidal symptoms, blurred vision, dilated pupils, vision disorders, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, supraventricular 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, gastritis, belching, gastric ulcer, dysphagia, halitosis, stomatitis, bloody 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, Steven-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle rigidity, myoclonus, opening disorder, dysuria, frequent urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urinary flow, urine odor changes, 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, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased blood creatine phosphokinase, increased blood potassium, increased blood cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, overflow incontinence, vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, microscopic colitis, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, opening disorders, urticaria, increased appetite, dizziness, insomnia, weakness, decreased appetite, dry mouth, vomiting, abdominal pain, drowsiness, abnormal sensations, abdominal discomfort, constipation, dyspepsia, fever, anxiety, dizziness, dysphagia, gastritis, delirium, chest discomfort, hyperhidrosis, dry skin, decreased blood pressure, limb pain, onychomycosis, visual disturbances, yawning, sedation, agitation, sleep disorders, abnormal dreams, orgasm dysfunction, decreased libido, ejaculation disorders, penile disorders, coughing, sore throat, hyperhidrosis, rash, itching, facial flushing, vascular disorders, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, aggression and anger, angioedema, erythema multiforme, extrapyramidal disorder, overflow incontinence, glaucoma, vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, muscle cramps, rash, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, tinnitus, opening disorder, urticaria, restlessness, abnormal dreams, worsening of depression, mood swings, suicide attempts, overdose, worsening of depression, edema, gastric ulcer, discomfort in the head, burning sensation, mental retardation, depression, increased blood bilirubin, intoxication by medication, hiccups, respiratory distress, restlessness, abnormal dreams, worsening of depression, mood swings, suicide attempts, overdose

This medication may be sensitive to air and moisture, thus it should be stored in a tightly closed container. The recommended storage temperature is between 15 to 30 degrees Celsius to maintain its effectiveness over time.

Appearance

A hard capsule with a blue upper half and a white lower half containing enteric-coated spherical granules that are white to light brown in color.

Package unit

28 capsules/PTP