Simbalsetin 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 initiated at 30mg once daily for 1 week to allow the patient to adapt 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, response to antidepressant treatment begins to appear after 2~4 weeks. Even after depressive symptoms have subsided, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine the need for continued treatment. 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 adapt to the medication, 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 60mg or more once daily is chosen, the dose should be increased by 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 continue treatment with this drug should periodically reassess the patient to determine the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, with or without food. 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. A lower starting dose may be considered for patients whose tolerability is a concern. 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 Because diabetic peripheral neuropathic pain has a variable course 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 adapt 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. 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 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 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 drug is 60mg once daily. To allow the patient to adapt to the medication, administer 30mg once daily for 1 week, then increase the dose to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), administering doses exceeding 60mg per 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 Dose adjustment according to 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 whenever possible, rather than abrupt discontinuation. If treatment is discontinued after more than 1 week of medication use, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take the medication every other day. However, the precise approach 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 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 must be allowed. Conversely, when starting an MAO inhibitor for the treatment of 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 be started on this drug because of the increased risk of serotonin syndrome. For patients who require other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is 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 considered 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (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

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 may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so careful assessment and close monitoring of patients and guardians are required when administering to this age group. This medication can cause a potentially life-threatening symptom called serotonin syndrome, so caution is needed when used in combination with serotonergic agents, and administration should be stopped immediately if any suspicious symptoms arise. This medication should not be used in patients who are taking or have recently taken certain drugs, especially MAO inhibitors, as it can pose significant risks. Patients with impaired liver function, end-stage renal disease, uncontrolled glaucoma or hypertension, and specific genetic metabolic disorders should not be administered this medication. Patients with a history of mania, bipolar disorder, or epilepsy as well as those with hypertension, cardiovascular disease, or bleeding disorders require careful monitoring and management when using this medication. Common side effects during treatment may include nausea, headache, dry mouth, drowsiness, dizziness, etc., which usually occur at the start of therapy and may lessen over time. Abrupt discontinuation of this medication may cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, and nausea, so the dosage should be gradually reduced under the guidance of a physician. There may be increases in blood pressure and heart rate, so patients with hypertension or heart disease should periodically check their blood pressure and heart rate. This medication can increase the risk of bleeding, so patients taking anticoagulants or medications that affect platelet function should be monitored closely for bleeding symptoms. Severe skin reactions can occur rarely, so immediate consultation with a physician is advised if symptoms such as rash or mucosal damage appear. Reports of liver damage have been associated with this medication, so if signs of liver dysfunction occur, administration should be halted and medical advice sought. Dizziness or drowsiness may occur while driving or operating hazardous machinery, so caution is required. Women who are pregnant or planning to become pregnant must consult a physician before taking this medication, and breastfeeding mothers are advised to avoid nursing while taking this medication. It is recommended not to use this medication in children and adolescents under 18, as its safety and efficacy have not been established. Severe symptoms such as coma, seizures, or serotonin syndrome may occur in case of overdose, and immediate emergency treatment should be sought if suspected. This medication should be stored in its original container in a safe place out of reach of children, and transferring it to another container should be avoided.

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 thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, somnolence, tremor, sensory disturbances, myoclonus, akathisia, nervousness, attention deficit disorder, taste disturbances, movement disorders, restless leg syndrome, low sleep quality, serotonin syndrome, seizures, akathisia, extrapyramidal symptoms, blurred vision, mydriasis, visual disturbances, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac dysrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, chills, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle spasms, muscle tension, myotonia, orofacial dystonia, dysuria, frequent urination, 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, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased creatine phosphokinase levels, increased potassium levels, increased cholesterol levels, acute pancreatitis, erythema multiforme, uremia, cutaneous vasculitis, microscopic colitis, seizures upon discontinuation of treatment, supraventricular dysrhythmia, trismus, reduced blood pressure, onychomycosis, worsening depression, edema, gastric ulcer, feeling of discomfort in the head, burning sensation, mental retardation, drug intoxication, overdose, hiccups, dyspnea, akathisia, abnormal dreams, emotional instability, suicide attempts, overdose, increased appetite

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

Appearance

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

Package unit

28 capsules (14 capsules/PTP*2)