Symbalsetin Capsule 60 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, regardless of meals. 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, response to antidepressant treatment begins after 2~4 weeks. Even after depressive symptoms have improved, continued use of the medicine 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 medicine is administered at a dose of 60mg once daily, regardless of meals. 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 exceeding 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 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 continue 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, regardless of meals. Although 120mg once daily is safe and effective, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability was reduced 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 diabetic peripheral neuropathic pain varies in its progression and pain control is empirical, the effects of this medicine should be assessed individually. Although the efficacy of treatment with this medicine 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 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses exceeding 60mg/day, and higher doses are 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 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 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. In patients who do not respond to the recommended dose (60mg/day), doses exceeding 60mg per day do not provide additional benefit and are associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this medicine for more than 13 weeks in the treatment of osteoarthritis pain have not been studied. 2. Older adults 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 (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, if possible, rather than abrupt discontinuation. To reduce the risk of withdrawal symptoms when discontinuing treatment after more than 1 week of use, it is recommended that the dose be gradually reduced starting 2 weeks before discontinuation. During this period, the dose may be halved or taken every other day. However, the exact 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 medicine, 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 since discontinuation of this medicine. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require other interventional procedures, including hospitalization, or treatment for a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, in 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. 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 administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at doses 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

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

This medication primarily treats disorders related to depression. First, this medication may increase the risk of suicidal thoughts or behaviors, especially in young patients aged 18 to 24; therefore, physicians must carefully consider the necessity and risks of treatment. All patients taking this medication should be closely monitored for worsening symptoms, suicidal tendencies, aggression, or other abnormal behavioral changes, and family members or caregivers should also be vigilant. Additionally, this medication has the potential to cause a serious side effect called serotonin syndrome, which may be heightened when combined with certain other medications. Symptoms of serotonin syndrome include changes in mental state, high fever, shivering, seizures, and nausea; if these symptoms occur, treatment must be stopped immediately, and medical attention should be sought. It is strictly prohibited to use this medication in combination with MAO inhibitors, especially during the 5 days following the cessation of an MAO inhibitor, as this poses significant risks. Patients with liver dysfunction, end-stage renal disease, uncontrolled glaucoma, hypertension, or certain sugar metabolism disorders should not take this medication. Commonly reported side effects when taking this medication include nausea, headache, dry mouth, drowsiness, and dizziness, mostly occurring in the early stages of treatment and improving over time. Discontinuation of the medication should be gradual under physician supervision as abrupt cessation can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and headache. This medication may raise blood pressure, so hypertensive patients should monitor their blood pressure frequently and be cautious of symptoms of orthostatic hypotension or fainting. Patients with a tendency to bleed or those taking anticoagulants should also be cautious due to an increased risk of bleeding. Severe skin reactions may occur; if any rash, blistering, or mucosal damage appears, the medication should be stopped immediately. Women who are pregnant or breastfeeding should consult with a doctor before taking this medication due to potential effects on the fetus or newborn. In principle, this medication should not be administered to children and adolescents, as safety and efficacy are not established. Elderly patients do not require dosage adjustments; however, they should be carefully monitored for adverse reactions during treatment. In cases of overdose, symptoms may include coma, seizures, or serotonin syndrome; therefore, adherence to the prescribed dosage is crucial, and immediate medical attention is required if an overdose occurs. This medication must be stored out of reach of children and kept in its original container for safety. Finally, caution is advised when driving or operating hazardous machinery due to possible drowsiness or dizziness.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• depression
• generalized anxiety disorder
• diabetic neuropathic pain
• suicidal ideation
• bruxism

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

Appearance

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

Package unit

28 capsules (14 capsules/PTP*2)