Myselta Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

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 the patient to adjust to the medication, 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 drug has not been clearly established. Maintenance treatment In general, the response to antidepressant treatment 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 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 the patient to adjust to the medication, and then increased to 60mg once daily. Although efficacy was demonstrated at 120mg once daily, there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose greater than 60mg once daily is selected, it 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 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 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. Consider starting at a lower dose in patients for whom tolerability is a concern. 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 drug should be evaluated individually. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, 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. 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 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 exceeding 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. 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. Patients with hepatic impairment This drug should not be used in patients with liver disease, as hepatic impairment may occur. 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). 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, it is recommended to gradually reduce the dose 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 taking into consideration the individual patient's circumstances, such as the duration of treatment and the dose being taken at the time of discontinuation. Switching from or to MAO inhibitors for the treatment of 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, if starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days must have elapsed after discontinuation of this drug. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start 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 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, this drug 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 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 a nonintravenous route (oral tablets or local injection) or intravenous administration of this drug 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

This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is used to treat symptoms associated with depression. There may be an increase in suicidal thoughts or behaviors during treatment, so young patients, especially those aged 18 to 24, should be closely monitored. A serious side effect known as serotonin syndrome may occur, especially when taken in conjunction with other serotonergic agents. This medication may be dangerous when used with certain medications, particularly MAO inhibitors, which should not be co-administered. Patients with liver or kidney function issues, uncontrolled hypertension, or narrow-angle glaucoma should not take this medication. Common side effects include nausea, headache, dry mouth, drowsiness, and dizziness, which require particular caution at the beginning of treatment. Abrupt discontinuation can lead to withdrawal symptoms; therefore, doses should be gradually reduced according to a doctor's direction. Blood pressure and heart rate should be monitored during treatment, and patients with bleeding tendencies need to be careful as the risk of bleeding may be increased. Severe skin reactions may occur, and if symptoms like rash or blisters develop, the medication should be discontinued immediately, and medical advice should be sought. This medication should be used cautiously during pregnancy and is not recommended while breastfeeding. Safety and efficacy have not been established in children or adolescents under 18 years of age. Caution is needed when driving or operating machinery due to potential drowsiness or dizziness. In cases of overdose, severe symptoms such as coma, seizures, and tachycardia may occur, requiring immediate emergency intervention. This medication should be kept out of reach of children and stored in its original container to prevent degradation of quality.

Nausea

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at room temperature between 15 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance

A hard capsule with the upper part in blue and the lower part in white, containing white to grayish-white enteric-coated spherical granules

Package unit

28 capsules/box [(14 capsules/PTP x 2)]