Yuroctin Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

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 exceeding 60mg per day, and the dose-response relationship for the efficacy of this medicine 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 reevaluate the patient to determine whether continued treatment is needed. 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 of more 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 known to be 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 should periodically reevaluate the patient to determine whether continued treatment is needed. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment The dose of this medicine is 60mg once daily, with or without food. A dose of 120mg once daily is safe and effective, 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, consider starting at a lower dose and gradually increasing it. Maintenance treatment Diabetic peripheral neuropathic pain has a variable course, and pain control is empirical; therefore, the effect of this medicine should be evaluated individually. The efficacy of this medicine for treatment exceeding 12 weeks has not been systematically studied in placebo-controlled trials, although 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, initiate treatment at 30mg once daily for 1 week and then increase to 60mg once daily. Some patients may respond to the starting dose. No evidence of additional benefit at doses exceeding 60mg/day has been observed, 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 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 studies exceeding 3 months; however, the need for continued treatment should be determined based on each patient's response. 5) Treatment of osteoarthritis pain inadequately responsive 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 for treatment of osteoarthritis pain for more than 13 weeks have not been studied. Elderly 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. Patients with hepatic impairment As hepatic impairment may occur, this medicine should not be used in patients with liver disease. 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). 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, gradual dose reduction starting 2 weeks before discontinuation is recommended 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 considering the individual patient's circumstances, such as the duration of treatment and the dose at the time of discontinuation. Switching from or to MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 5 days should elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions should be considered. There may be circumstances in which linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this medicine. 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 medicine 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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

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

This medication is used for the treatment of psychiatric disorders such as major depressive disorder. There may be an increased risk of suicidal thoughts or behaviors while taking this medication, especially in young patients aged 18 to 24, requiring careful evaluation and continuous monitoring by a physician. Serotonin syndrome, a serious side effect, may occur; therefore, it is essential to consult with a doctor if combined with other serotonergic medications. This medication may cause an increase in blood pressure or a rapid heartbeat, necessitating caution in patients with hypertension or heart conditions. Orthostatic hypotension or fainting symptoms may occur, especially when initiating treatment or increasing the dose, so caution is particularly needed at these times. Patients with a tendency to bleed or those taking anticoagulants need to be careful as the risk of bleeding may be increased. Severe skin reactions may arise, so if signs of rash, blistering, or mucosal damage occur, discontinue taking the medication immediately and consult a doctor. Elderly patients or those with impaired liver or kidney function should use this medication with caution, and abrupt discontinuation may trigger withdrawal symptoms, so gradual tapering is recommended. Pregnant or breastfeeding women should consult a physician before taking this medication, as side effects may occur in newborns during late pregnancy. This medication is not recommended for use in children and adolescents under 18 years, and suicidal behaviors should be closely monitored during treatment. Dizziness or drowsiness may occur when driving or operating dangerous machinery, so caution is required. Overdose may lead to coma, seizures, serotonin syndrome, etc., so adherence to the prescribed dosage is crucial, and immediate medical attention should be sought in case of unusual symptoms. This medication should be stored in its original container and kept out of reach of children.

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, agitation, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, somnolence, tremors, sensory disturbances, dystonia, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, dizziness, ear pain, palpitations, tachycardia, cardiac arrhythmia, increased blood pressure, flushing, hypertension, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, 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 sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonus, trismus, dysuria, urinary urgency, nocturia, urinary 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, fatigue, falls, chest pain, hot/cold sensations, lethargy, thirst, abnormal sensations, chills, gait disturbance, weight loss, weight gain, increased serum creatine phosphokinase, elevated serum potassium, increased serum cholesterol, nausea, constipation, insomnia, dry mouth, dizziness, drowsiness, increased sweating, diarrhea, fatigue, decreased appetite, vomiting, blurred vision, poor appetite, sedation, palpitations, asthenia, dizziness, tremors, sensory disturbances, migraine, taste disturbances, insomnia, agitation, sleep disturbances, abnormal dreams, orgasmic disorders, decreased libido, ejaculation disorders, penile disorders, cough, sore throat, hyperhidrosis, rash, pruritus, facial flushing, myocardial infarction, palpitations, tachycardia, ear pain, hypothyroidism, blurred vision, diplopia, vision loss, bloating, belching, gastritis, halitosis, gastric ulcer, bloody stool, melena, chills, tremors, abnormal sensations, burning sensation, cold sensation, somatic discomfort, thirst, gait disturbances, gastroenteritis, laryngitis, weight gain, elevated serum cholesterol levels, dehydration, hyperlipidemia, dyslipidemia, musculoskeletal pain, muscle stiffness, muscle cramps, taste disorders, asthenia, sensory disturbances, concentration difficulties, hyperkinesia, dystonia, sleep quality deterioration, speech disturbances, abnormal dreams, sleep disturbances, apathy, bruxism, disorientation, confusion, irritability, severe mood swings, suicide attempts, suicide, urinary disorders, urinary urgency, nocturnal enuresis, polyuria, abnormal urine odor, sexual aversion, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat constriction, facial flushing, flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal disorders, lability, cutaneous vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, muscle cramps, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, worsening of depression, edema, gastric ulcer, discomfort in the head, burning sensation, mental retardation, depression, elevated serum bilirubin, intoxication status, hiccups, dyspnea

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

Appearance

Enteric-coated spherical granules that are white to light brown inside a hard capsule with a blue upper part and a white lower part

Package unit

28 capsules (14 capsules PTP * 2)