Duloxetine Capsules 60mg (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 them 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 therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms improve, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine whether continued treatment is needed. 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 them to adjust 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 more than 60mg once daily is selected, 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 reassess the patient to determine whether continued treatment is needed. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, with or without food. Although doses of 120mg once daily are safe and effective, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased 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, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies 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 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses 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 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 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 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), administration of 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 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 120mg daily dose 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 needed 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 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 the medication 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 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, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should 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 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 there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for 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 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 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 concerns regarding safety and efficacy. The safety and efficacy of this medicine for indications other than major depressive disorder have not been studied.

This medication is primarily used to treat symptoms related to depression. However, there may be an increased risk of suicidal thoughts or behaviors, particularly in young adults aged 18 to 24, adolescents, and children, so the physician must carefully assess the need for treatment and risks. Patients should be closely monitored for worsening depression symptoms, suicidal thoughts, aggression, or anger while on this medication, and families or caregivers should also observe the patient and consult a physician if any issues arise. Furthermore, this medication is not approved for children and adolescents. This medication can cause a serious side effect known as serotonin syndrome, which is more likely to occur when taken with other serotonergic medications. Symptoms of serotonin syndrome may include changes in mental status, unstable blood pressure, tremors, muscle contractions, nausea, and vomiting, so immediate medical attention is required if these symptoms occur. This medication should not be taken with certain medications, particularly monoamine oxidase inhibitors (MAOIs), as it can be very dangerous. Patients with impaired liver function, severe kidney impairment, uncontrolled glaucoma, or hypertension should also avoid using this medication. Common side effects during administration can include dizziness, drowsiness, headaches, dry mouth, and nausea, which typically occur at the start of treatment and lessen over time. Abrupt discontinuation of the medication may provoke withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced under the guidance of a physician. This medication can cause elevated blood pressure and increased heart rate, so patients with hypertension or heart disease should regularly monitor their blood pressure. Orthostatic hypotension or fainting can also occur, so caution is advised. There may be an increased risk of bleeding, so patients taking anticoagulants or drugs affecting platelet function should consult with their physician. Rarely, serious skin reactions or liver damage may occur; hence, immediate medical attention should be sought if symptoms such as rash or jaundice appear on the skin. Women who are pregnant or breastfeeding should consult with their physician before taking this medication, and its use is not recommended in children under 18 years of age. Elderly patients should also use caution, particularly when taking high doses. Overdose may lead to coma, seizures, or serotonin syndrome, requiring immediate emergency treatment. This medication may cause drowsiness or dizziness when driving or operating machinery, so caution is necessary. The risk of side effects may increase when taken with antidepressants or other central nervous system medications, so it is important to inform the physician about any other medications being taken. Finally, this medication should be kept out of the reach of children and stored in its original container to prevent misuse or degradation in quality.

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

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

Appearance

A blue hard capsule with yellow-green at the bottom containing enteric-coated spherical granules that are white to light brown in color.

Package unit

28 capsules/PTP