Dulowin Capsule 30 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 initiated 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 of this medicine exceeding 60mg per day, and the dose-response relationship for its efficacy has not been clearly established. Maintenance treatment In general, the 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 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 initiated 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 exceeding 60mg. Nevertheless, if a dose greater than 60mg once daily is selected, 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 medicine for generalized anxiety disorder, that is, for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who elect 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 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 Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this medicine should be assessed individually. Although the efficacy of this medicine when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials, a 1-year open-label safety study has been 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 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 was observed at doses exceeding 60mg/day, even in patients who did 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. In placebo-controlled trials of fibromyalgia treatment, 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, 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 medicine 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 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 less than 30mL/min). 6. Discontinuation of treatment When discontinuing this medicine, 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 use, it is recommended that the dose be gradually reduced over 2 weeks to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or the medicine may be taken every other day. However, the exact approach should be determined based on the individual patient's circumstances, including the duration of treatment and the dose at the time of discontinuation. 7. Switching from MAO inhibitors used to treat psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor used to treat a psychiatric disorder and initiating treatment with this medicine. Conversely, at least 5 days should elapse after discontinuing this medicine before initiating an MAO inhibitor to treat a psychiatric disorder. 8. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not initiate treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefit of treatment with linezolid or intravenous methylene blue is judged to outweigh the risk of serotonin syndrome, this medicine 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 medicine 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 medicine 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

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 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 symptoms associated with depression. When taking this medication, there may be an increase in suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, who should be closely monitored. A serious side effect known as serotonin syndrome may occur, which includes various symptoms such as changes in mental status, high fever, tremors, seizures, and nausea. The risk can increase when taken alongside other serotonergic drugs or certain psychiatric medications, so always consult a doctor when taking together. This medication is contraindicated with certain drugs, especially MAO inhibitors, and should never be taken together due to potential risks. It is not to be administered to patients with severely impaired liver or kidney function, uncontrolled hypertension, or specific ocular conditions. During treatment, blood pressure and heart rate should be periodically monitored, and caution is advised as orthostatic hypotension or fainting symptoms may occur. Increased risk of bleeding may occur when taking anticoagulants or drugs that affect platelet function, so special precautions should be taken in such cases. Abrupt discontinuation of the medication may lead to withdrawal symptoms, including dizziness, sensory disturbances, insomnia, and anxiety, so dosage should be decreased gradually as instructed by a physician. Common side effects such as drowsiness, dizziness, dry mouth, headache, and nausea may occur and are often observed at the beginning of treatment, gradually resolving over time. Pregnant or breastfeeding women should consult their physician regarding the use of this medication, and it is not recommended for children and adolescents due to safety not being established. Caution is needed when driving or operating hazardous machinery during treatment, and extra care should be taken if combined with alcohol or sedatives. In overdose situations, signs may include coma, seizures, and heart abnormalities, thus adherence to prescribed dosages is essential, and immediate medical assistance should be sought in emergencies. This medication should be stored out of reach of children and in its original container.

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 ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremor, paresthesia, tonic-clonic seizure syndrome, akathisia, neuroticism, attention deficit disorder, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, ventricular arrhythmia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stools, elevated liver enzyme levels, hepatitis, acute liver injury, liver failure, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity, diaphoresis, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myositis, jaw clenching disorder, dysuria, frequent urination, nocturia, urinary hesitation, 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 sensation, chills, gait disturbances, weight loss, weight gain, increased blood creatine phosphokinase, increased blood potassium, increased blood cholesterol, asthenia, sensory impairment, concentration difficulties, dyskinesia, dysarthria, abnormal dreams, disorientation, confusion, irritability, severe mood swings, suicide attempt, urination disorder, urgency in urination, nocturnal enuresis, polyuria, abnormal foul odor of urine, sexual aversion, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat constriction, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, erythema multiforme, angioedema, skin vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, dysphagia, dry skin, decreased blood pressure, limb pain, onychomycosis, visual impairment

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. Additionally, it is important to store it at room temperature between 15 degrees and 30 degrees Celsius to maintain its efficacy.

Appearance

A blue capsule with a white to light brown delayed-release spherical granule inside.

Package unit

28 capsules/PTP