Simbalta 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 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 a 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 improved, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reevaluate 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 adjust to the medication, and then increased to 60mg once daily. Although efficacy has been demonstrated at 120mg once daily, 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, i.e., 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 the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at a dose of 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. For patients with concerns about tolerability, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a low dose and gradually increasing it. Maintenance treatment Diabetic peripheral neuropathic pain has a variable course, and pain control is empirical; therefore, the effects of this drug should be evaluated individually. Although efficacy with administration of this drug 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 has been observed with doses exceeding 60mg/day, even in patients who do not respond to 60mg, and use 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. For 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 for more than 13 weeks in 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 This drug should not be used in patients with liver disease because hepatic impairment may occur. 5. Patients with renal impairment No dose adjustment is required 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 (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, gradual dose reduction beginning 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 exact approach should be determined based on the individual patient's circumstances, including duration of treatment and the dose being taken at the time of discontinuation. 7. Switching from or to MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug. Conversely, at least 5 days should elapse after discontinuing this drug before starting an MAO inhibitor for the treatment of psychiatric disorders. 8. 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 treatment of a more urgent 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 comes 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 doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Children's dosage

This medicine should not be used to treat major depressive disorder in pediatric patients and adolescents under 18 years of age. The safety and efficacy of this medicine have not been established for other indications either.

This medication is primarily used to treat psychiatric disorders related to depression. When administered to children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors; therefore, a physician should carefully assess whether to administer it. During the early stages of treatment, abnormal behavioral changes such as suicidal thoughts, aggression, or anger may occur, so both the patient and those around them should observe carefully. Additionally, this drug can cause a serious side effect known as serotonin syndrome, affecting the nervous system and autonomic nervous system, leading to changes in mental state, high fever, tremors, seizures, nausea, and other symptoms. The risk is particularly heightened when used in combination with other serotonergic medications or certain drugs, so extreme caution should be exercised in such cases. This drug should not be administered to specific patients, such as those allergic to its ingredients or currently taking MAO inhibitors, those with liver disease, severe kidney disease, uncontrolled glaucoma, or hypertension. Caution is also warranted in patients with liver dysfunction, reduced kidney function, hypertension or heart disease, those taking medications affecting bleeding tendencies or anticoagulation, the elderly, or those who are dehydrated. Common side effects of using this medication include nausea, headaches, dry mouth, drowsiness, dizziness, and most occur early in treatment and improve over time. Abruptly stopping treatment can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, fatigue, anxiety, nausea, and muscle pain, so the dosage should be gradually reduced. This drug can increase blood pressure and heart rate, so patients with hypertension should monitor their blood pressure regularly. Symptoms of orthostatic hypotension and fainting may also occur. Due to bleeding risk, patients taking anticoagulants or drugs affecting platelet function should be especially cautious. Rarely, severe skin reactions, liver damage, or severe hepatitis can occur, so if symptoms such as rash, jaundice, or severe fatigue appear, the patient should consult a physician immediately. Caution is needed when driving or operating machinery, as drowsiness or dizziness may occur. During pregnancy, it should only be administered when absolutely necessary due to risks to the fetus, and breastfeeding is not recommended as it is secreted in small amounts in breast milk. There is a potential for interactions with other medications while taking this drug, so patients must inform their doctor or pharmacist of any other medications they are taking. In case of overdose, possible symptoms include coma, seizures, and serotonin syndrome, which requires immediate emergency treatment. Lastly, this medication has not been established as safe and effective for children under 18 years of age.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• insomnia
• anxiety
• decreased libido
• anorgasmia
• restlessness

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, with storage temperatures maintained between 1 degree and 30 degrees Celsius. This helps preserve the efficacy of the drug over time.

Appearance

A hard capsule with an upper blue and lower white color, containing white enteric-coated spherical granules.

Package unit

28 capsules (14 capsules/PTPX2)/carton