Turbalta Capsule 60 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, 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, 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 recurrence. The physician should periodically reassess 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, 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 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 use of this drug should periodically reassess 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. 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, initiation at a lower dose may be considered. For patients with renal impairment, which often occurs as a complication of diabetes, initiation at a lower dose followed by gradual dose increases should be considered. Maintenance treatment Because diabetic peripheral neuropathic pain varies in progression and pain control is empirical, the effect of this drug should be evaluated individually. Although the efficacy of this drug when administered 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 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 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 considered a chronic condition. In placebo-controlled trials of fibromyalgia treatment, 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 inadequately responsive 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 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 Dosage 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, if 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 the medication may be taken every other day. However, the specific approach 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 MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days should have elapsed after discontinuation of 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 requiring more urgent treatment of a 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 there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 occurs first. Treatment with this drug may be restarted 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 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

Children and adolescents under 18 years of age: This drug 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 drug for conditions other than major depressive disorder have not been studied.

This medication is primarily used to treat psychiatric disorders related to depression. However, caution is needed as there may be an increased risk of suicidal thoughts or actions in individuals under 18 years of age, as well as young adults aged 18-24. Changes in the patient's condition should be closely monitored during treatment, and family members or caregivers should watch for any unusual behaviors. This medication exerts its effects by inhibiting the reuptake of serotonin and norepinephrine, but caution should be taken as serotonin syndrome, which can be life-threatening, may occur when used in conjunction with other serotonin-acting drugs. It should not be used with MAO inhibitors, and if co-administration is necessary, consultation with a doctor is required. This medication should not be administered to patients with severely impaired liver or kidney function, uncontrolled hypertension, or glaucoma, nor those with certain genetic sugar metabolism disorders. During treatment, commonly reported symptoms include nausea, headache, dry mouth, drowsiness, and dizziness, which usually occur early in the treatment and improve over time. Abrupt discontinuation may cause withdrawal symptoms such as dizziness, sensory changes, anxiety, and nausea; hence, dose reduction should be gradual. This medication can cause increased blood pressure or heart rate, so patients with hypertension or heart disease should regularly monitor their blood pressure. Orthostatic hypotension and syncope have also been reported, requiring caution during initial administration or dose increases. Patients with bleeding tendencies or those taking anticoagulants or drugs affecting platelet function should be cautious as bleeding risk may increase. Severe adverse reactions such as serious skin reactions, liver damage, and psychomotor agitation can occur rarely, and any abnormal symptoms should prompt immediate consultation with a doctor. Pregnant or nursing women must consult with a doctor before taking this medication, as taking it in late pregnancy may lead to withdrawal syndrome in the newborn. Caution is required when driving or operating dangerous machinery as this medication may cause drowsiness or dizziness. This medication may interact with other drugs, so if taking other medications, it is essential to inform a doctor or pharmacist. Finally, keep this medication out of the reach of children and store it in its original container to maintain quality.

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 thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, lethargy, tremor, paresthesia, myoclonus, restlessness, irritability, attention deficit, taste abnormalities, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, pupil dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertension-induced seizures, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stool, elevated liver enzyme levels, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, phototoxic reaction, cold sweat, tendency to bruise easily, Steven-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, fasciculation, bruxism, dysuria, polyuria, nocturia, urinary hesitation, urinary retention, polyuria, decreased urinary 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 sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, elevated serum creatine phosphokinase, elevated serum potassium, elevated serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, urinary incontinence, cutaneous vasculitis, microscopic colitis, supraventricular arrhythmia, trismus, elevated serum bilirubin, intoxicated state, overdose, hiccups, dyspnea, sexual indifference, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, throat tightness, hypotension, onychomycosis

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. Additionally, it is important to store the medication at an appropriate temperature between 15 degrees and 30 degrees Celsius, avoiding excessively hot or cold conditions.

Appearance

A hard capsule with a blue upper and yellow-green lower part, containing white to pale brown enteric-coated spherical granules.

Package unit

28 capsules/PTP