Dulocen Capsule 30 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 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 above 60mg per day, and a dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance treatment In general, 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 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. Efficacy has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses above 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 above 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 60mg once daily, with or without food. Although 120mg once daily is safe and effective, there is no evidence of additional benefit at doses above 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 course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. Although the efficacy of treatment with this drug for more than 12 weeks has not been systematically studied in placebo-controlled trials, an open-label safety study was conducted for 1 year. 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses above 60mg/day, and use of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is known to be 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 and then increase the dose to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), doses above 60mg per day provide no additional benefit and are associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this drug for treatment of osteoarthritis pain for more than 13 weeks 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 (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, it is recommended that the dose be gradually reduced beginning 2 weeks before discontinuation 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 based on the individual patient's circumstances, such as 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, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should elapse after discontinuing this drug. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug 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 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 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 nonintravenous routes (oral tablets or local injection) or with intravenous administration of this drug at 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: This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years because of concerns about its safety and efficacy. 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 various psychiatric disorders associated with depression. First, this medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Therefore, when prescribing to this age group, the physician must carefully assess the necessity and risks of treatment. Additionally, this medication works by inhibiting the reuptake of neurotransmitters serotonin and norepinephrine, which can lead to a serious side effect known as serotonin syndrome. Symptoms may include changes in mental status, autonomic instability, neuromuscular problems, seizures, and gastrointestinal disturbances. If these symptoms occur during treatment, immediate consultation with healthcare professionals is necessary. Particularly, the risk of serotonin syndrome is heightened if this medication is taken in combination with MAO inhibitors or if MAO inhibitors are taken shortly after discontinuing it; thus, they should never be used together. This medication should not be used in patients with poor liver function, end-stage kidney disease, uncontrolled glaucoma, or hypertension. Blood pressure and heart rate should be monitored periodically during use, and patients with hypertension or heart disease should be especially cautious. Also, this medication may increase the risk of bleeding, so patients taking anticoagulants or medications affecting platelet function should be alert to signs of bleeding. Suddenly stopping this medication may cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, headaches, so it is important to taper off gradually under medical supervision. Drowsiness or dizziness may occur, so caution should be taken when driving or operating hazardous machinery. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, and special caution is needed in late pregnancy as adverse effects may occur in the newborn. This medication is generally not recommended for use in patients under 18 years of age due to uncertainties regarding safety and efficacy.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, painful diabetic neuropathy, laryngitis, anaphylactic reaction, hypersensitivity disorder, hypothyroidism, 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, somnolence, tremor, sensory disturbances, acanthosis nigricans, restless leg syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmias, 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, hematochezia, elevated liver enzyme levels, 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, muscle twitching, open mouth disorder, dysuria, frequent urination, nocturia, hesitancy in urination, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual irregularities, 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, erythema multiforme, urticaria, cutaneous vasculitis, microscopic colitis, supraventricular arrhythmias, trismus, increased serum bilirubin, drug intoxication, overdose, hiccups, dyspnea, decreased blood pressure, onychomycosis, dry skin, chest discomfort, fever, stupor, dysphagia, instability, memory impairment, confusion, weakness, hallucinations, syncope, seizures, coma, respiratory arrest, limb pain, onychomycosis, increased serum bilirubin, restlessness, abnormal dreams, worsening depression, emotional fluctuations, suicide attempts, overdose, worsening depression, edema, gastric ulcer, head discomfort, burning sensation, intellectual disability, depression, hiccups, suicidal ideation, suicidal behavior

This medication should be stored in an airtight container to protect it from air and moisture, with the storage temperature maintained between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

A hard capsule with an upper purple and lower white color containing white to light brown enteric-coated spherical granules.

Package unit

30 capsules/bottle, 100 capsules/bottle, 200 capsules/bottle