Julotin 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 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 whether continued treatment is necessary. 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 the patient to adjust to the medication, and then increased to 60mg once daily. Although efficacy was demonstrated at 120mg once daily, there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose greater than 60mg once daily is chosen, 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, 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 necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at a dose of 60mg once daily, with or without food. Although 120mg once daily is safe and effective, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased 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, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because the progression of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be assessed 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 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 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 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 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 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 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 taken every other day. However, the exact method should be determined by considering 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 an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and initiating treatment with this drug, an interval of at least 14 days should be observed. Conversely, when initiating an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should have elapsed since 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 who require treatment of 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. 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 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 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

3. 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 its safety and efficacy. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This drug is used to treat psychiatric disorders related to depression. Caution should be exercised when prescribing this medication to children, adolescents, and young adults aged 18 to 24, as there may be an increased risk of suicidal thoughts or behavior. Patients of all ages taking this drug should be closely monitored for unusual behaviors such as suicidal tendencies, aggression, anger, etc., and family members or caregivers should also observe the patient closely and consult a physician if any concerning signs arise. Particularly in children and adolescents, the use of this drug has not been approved; therefore, it is safest not to prescribe it. This medication can cause a serious adverse effect known as serotonin syndrome, which is an emergency situation characterized by changes in mental status, high fever, tremors, seizures, nausea, and vomiting. Therefore, it should be used with caution when taken with other drugs that affect serotonin, and co-administration with MAO inhibitors is prohibited. This medication should not be administered to individuals with allergies to the active ingredient or additives, severe liver disease or end-stage kidney disease, or uncontrolled glaucoma or hypertension. Additionally, patients with fructose intolerance or certain genetic disorders should avoid taking this medication. Patients with mania or bipolar disorder, mild to moderate renal impairment, heart disease, bleeding tendencies, and older patients should be treated with special caution when prescribing this drug. Common side effects may include nausea, headaches, dry mouth, drowsiness, and dizziness, and most often occur early in treatment but improve over time. Abrupt discontinuation of the drug may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors; thus, the dosage should be gradually reduced according to a physician's instructions. This medication can cause increases in blood pressure and heart rate, so patients with hypertension or heart disease should have their blood pressure monitored regularly. Orthostatic hypotension or fainting may occur, so extra caution is required, especially during the early stages of treatment. There is a risk of bleeding, so patients taking anticoagulants or drugs affecting platelet function should be cautious. Severe skin reactions may occur, so if rashes, blisters, or mucosal damage occurs, administration should be stopped immediately. Hepatic dysfunction may develop, so if symptoms of hepatitis or jaundice appear, medical advice should be sought immediately. Caution is advised as dizziness or drowsiness may occur while driving or operating machinery. Pregnant or breastfeeding women must consult a physician before taking this medication, as there may be adverse effects on the newborn, particularly in the late stages of pregnancy. The safety and efficacy of this medication have not been established for children under 18 years of age, so its use is not recommended. In the case of overdose, risks include coma, seizures, and serotonin syndrome; emergency treatment should be sought immediately. This medication should be kept out of the reach of children and stored in its original container to prevent deterioration.

Dizziness, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, agitation, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, hypersomnia, tremors, sensory disturbance, tonic-clonic syndrome, inability to sit still, neurobehavioral sensitivity, attention deficit, taste disturbance, movement disorder, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crises, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastritis, belching, gastric reflux, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzymes, hepatitis, acute liver injury, liver failure, 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, myotonia, open mouth syndrome, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculatory dysfunction, 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, increased serum potassium, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, cutaneous vasculitis, edema, decreased blood pressure, onychomycosis, exacerbation of depression, emotional lability, suicide attempt, overdose, urticaria, drug intoxication, hiccups, respiratory distress, opening difficulties

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a white lower part containing white to grayish-white enteric-coated sphere-shaped granules.

Package unit

28 capsules/PTP