Dulowin Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This medicine 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 medicine, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses above 60mg per day, and the dose-response relationship for the efficacy of this medicine has not been clearly established. Maintenance treatment In general, a therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms improve, 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 medicine 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 medicine, 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 above 60mg once daily is chosen, the dose should be increased in 30mg increments 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 medicine 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 medicine should periodically reassess the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medicine 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 above 60mg. Tolerability decreased at higher doses. For patients with concerns about tolerability, consider starting at a lower dose. 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 medicine should be assessed individually. Although efficacy of treatment with this medicine 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 medicine is 60mg once daily. To allow the patient to adjust to the medicine, 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses above 60mg/day, and administration 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 medicine 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 medicine is 60mg once daily. To allow the patient to adjust to the medicine, administer 30mg once daily for 1 week and then increase 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 medicine for more than 13 weeks in the treatment of osteoarthritis pain have not been studied. 2. Elderly patients Dose adjustment based on age is not recommended. However, as with other medicines, 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 medicine 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 medicine should not be administered to patients with end-stage renal disease (patients requiring dialysis) or severe renal impairment (creatinine clearance below 30mL/min). 6. Discontinuation of treatment When discontinuing this medicine, gradual dose reduction over at least 1~2 weeks is recommended, if possible, rather than abrupt discontinuation. When discontinuing treatment after more than 1 week of medication use, 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 it every other day. However, the exact method should be determined by taking into account the individual patient's circumstances, such as the duration of treatment and the dose being taken at the time of discontinuation. 7. Switching to or from MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 days must elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this medicine because of the increased risk of serotonin syndrome. For patients requiring 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 medicine. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medicine 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

Pediatric patients and adolescents under 18 years of age: Because of concerns regarding safety and efficacy, this drug should not be used to treat major depressive disorder in pediatric patients and adolescents under 18 years of age. The safety and efficacy of this drug for indications other than major depressive disorder have not been studied.

This medication is used for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy pain, and fibromyalgia. When taking this medication, there may be an increased risk of suicidal thoughts or behaviors, so special caution should be exercised, especially in young adults aged 18 to 24, children, and adolescents. There is a risk of developing serious side effects such as serotonin syndrome when this medication is taken with other serotonergic medications. It is prohibited to co-administer with MAO inhibitors or to switch to them within a certain period. Patients with severely impaired liver or kidney function, uncontrolled hypertension, or angle-closure glaucoma should not take this medication. Blood pressure and heart rate should be monitored periodically during treatment, as there may be risks of orthostatic hypotension or syncope. Patients with a tendency to bleed or those taking anticoagulants or medications affecting platelet function may have an increased risk of bleeding. Severe skin reactions may occur rarely, and if symptoms such as rash, blistering, or mucosal damage occur, the medication should be discontinued immediately. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders, so it's advised to gradually reduce the dosage as per a doctor's guidance. Pregnant or nursing women should consult with a doctor before taking this medication, especially in late pregnancy due to the risk of neonatal withdrawal syndrome. The safety and efficacy in children and adolescents under 18 years of age have not been established and is not recommended. Caution is necessary while driving or operating dangerous machinery due to possible symptoms of dizziness or drowsiness. This medication may interact with various drugs, so inform healthcare professionals if taking other medications. In case of overdose, there is a risk of coma, seizures, and serotonin syndrome; immediate emergency treatment is required. Store this medication out of the reach of children and in its original container to prevent deterioration.

Nausea, 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, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremor, sensory disturbances, dystonia, restlessness, nervous irritability, attention deficit disorder, taste disturbances, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, dizziness, ear pain, palpitations, tachycardia, arrhythmias, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, pharyngolaryngeal stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, distention, 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, light sensitivity, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, open-mouth disorder, dysuria, increased frequency of urination, nocturia, urine hesitancy, urinary retention, polyuria, decreased urine 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 sensation, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, sedation, asthenia, sensory disturbances, migraine, taste disturbances, nightmares, decreased libido, ejaculation disorder, penile disorders, cough, sore throat, hyperhidrosis, pruritus, facial flushing, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal disorders, enuresis, cutaneous vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crises, microscopic colitis, muscle cramps, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, dysphagia, dry skin, decreased blood pressure, limb pain, onychomycosis, vision deterioration, yawning, worsening depression, edema, gastric ulcer, discomfort in the head, burning sensation, mental retardation, depression, increased serum bilirubin, intoxication, hiccups, dyspnea, restlessness, abnormal dreams, mood swings, suicide attempt, overdose, weight gain, elevated ALT, fatigue, edema, cold sweat, hyperhidrosis, rash, elevated AST, halitosis, gastric ulcer, gastritis, abdominal pain, hypersomnia, discomfort in the head, burning sensation, mental retardation, restlessness, delirium, nervous irritability, agitation, apathy, anger, nightmares, suicide attempt, depression, mania, hypersensitivity, warmth sensation, pruritus, urticaria, weight loss, increased serum bilirubin, intoxication, overdose, hiccups, dyspnea, erectile dysfunction, delayed ejaculation, sexual dysfunction, flushing, suicidal ideation, suicidal behavior, coma, seizures

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to keep it in a cool place between 15 and 30 degrees Celsius to maintain its effectiveness.

Appearance

An upper blue, lower light yellow-green hard capsule containing spherical enteric-coated granules that are white to light brown in color.

Package unit

28 capsules/PTP