Tuvarta 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 started at 30mg once daily for 1 week to allow them to adjust to the medication, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses of this drug 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 use of the medication 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 started at 30mg once daily for 1 week to allow them to adjust to the medication, and then increased to 60mg once daily. Efficacy was 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 chosen, 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 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. 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 often occurs as a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment The course of diabetic peripheral neuropathic pain varies, and pain control is empirical; therefore, the effect of this drug should be assessed individually. The efficacy of this drug when administered for more than 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 drug is 60mg once daily. To allow the patient to adjust to the medication, 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 of this drug exceeding 60mg/day, 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 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 lasting more than 3 months; however, the need to continue 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, then increase to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), doses exceeding 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 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 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 in 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 discontinuing treatment after more than 1 week of medication use, gradually reducing the dose starting 2 weeks beforehand 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 specific method should be determined based on 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days must have elapsed 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 requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, administration 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, immediately discontinue this drug and administer linezolid or intravenous methylene blue. 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a nonintravenous route (oral tablets or local injection) or with intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

Children's dosage

3. Children and adolescents under 18 years of age Children and adolescents under 18 years of age: This drug should not be used to treat major depressive disorder 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 drug is primarily used to treat major depressive disorder and various psychiatric disorders. First, this drug may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults; therefore, extreme caution is necessary when administering to patients in this age group. Moreover, this drug works by inhibiting the reuptake of neurotransmitters serotonin and norepinephrine, which may result in serious side effects known as serotonin syndrome; caution is needed when used in combination with certain drugs. In particular, concomitant use with MAO inhibitors is prohibited. This drug should not be administered to patients with severely impaired liver or kidney function, uncontrolled hypertension, narrow-angle glaucoma, or certain genetic disorders. When administering, caution is required for patients with a history of mania, bipolar disorder, epilepsy, bleeding tendencies, and elderly patients; side effects like hyponatremia or orthostatic hypotension need to be watched for. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness can frequently occur during the use of this drug. Rarely, liver damage, heart abnormalities, and severe skin reactions may occur. If any abnormal symptoms appear, consult a doctor immediately. Additionally, suddenly stopping this drug can cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, and anxiety; hence, dosage should be gradually reduced according to a physician's guidance. Women who are pregnant or breastfeeding should consult a doctor before taking this drug, and special caution is required in late pregnancy due to potential side effects in newborns. Finally, during driving or machine operation, dizziness or drowsiness may occur, so caution is necessary. Also, potential drug interactions should be discussed with a physician if taking other medications.

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 disturbances, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremors, sensory disturbances, myoclonus, restless leg syndrome, hypersensitivity, attention deficit, taste disturbances, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac dysrhythmia, hypertension, 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 enzymes, hepatitis, acute hepatic injury, hepatic failure, jaundice, 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, myotonia, trismus, dysuria, frequent urination, 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, increased creatine phosphokinase in the blood, increased potassium in the blood, increased cholesterol in the blood, acute pancreatitis, anaphylaxis, erythema multiforme, enuresis, cutaneous vasculitis, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, restless leg syndrome, seizures upon discontinuation, supraventricular dysrhythmia, trismus, urticaria, dysphagia, dry skin, decreased blood pressure, limb pain, onychomycosis, vision deterioration, worsened depression, edema, peptic ulcer, discomfort in the head, burning sensation, mental retardation, drug intoxication, hiccups, dyspnea, restless legs syndrome, abnormal dreams, emotional lability, suicide attempt, overdose, increased appetite

This drug must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 15 and 30 degrees Celsius to prolong the drug's effectiveness and safety.

Appearance

A hard capsule with a blue upper part and a white lower part containing white to light brown enteric-coated spherical granules

Package unit

28 capsules/PTP