Duloxetine Capsules 30 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, 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 the dose-response relationship for the efficacy of this medicine 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 have improved, continued medication use for several months is recommended to prevent relapse. The physician should periodically reevaluate 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, 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 was 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 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 known to be 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 extend treatment with this medicine should periodically reevaluate 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, with or without food. Although 120mg once daily is safe and effective, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. For patients whose tolerability is a concern, starting at a lower dose may be considered. For patients with renal impairment, which often occurs as a complication of diabetes, starting at a lower dose and gradually increasing the dose should be considered. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this medicine should be assessed individually. Although the efficacy of this medicine 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 medicine 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 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 medicine was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term trials lasting more than 3 months; however, the need for continued treatment should be determined based on each individual 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 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), 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 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 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 in 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 (patients 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 whenever possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, it is recommended that the dose be gradually reduced beginning 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken every other day. However, the appropriate method should be determined by considering the individual patient's circumstances, such as 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 medicine, 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 medicine. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue 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 occurs first. Treatment with this medicine 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 medicine 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 such use.

Children's dosage

3. Children and adolescents under 18 years of age Children and adolescents under 18 years of age: Because of concerns regarding safety and efficacy, this medicine should not be used to treat major depressive disorder. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain. When taking this medication, there may be an increase in suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, requiring careful judgment and ongoing monitoring by a physician. Additionally, there is a risk of developing serotonin syndrome, which can be life-threatening, if this medication is taken with certain drugs, particularly MAO inhibitors, and they should never be used together. Patients with severely impaired liver or kidney function, uncontrolled hypertension, glaucoma, or certain genetic disorders should not be prescribed this medication. Common side effects while taking this medication may include nausea, headache, dry mouth, drowsiness, and dizziness, most of which occur early in treatment and improve over time. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, and anxiety, necessitating a gradual dose reduction as per the physician's instructions. This medication may increase blood pressure and heart rate, hence patients with hypertension or heart diseases require regular monitoring of blood pressure and heart rate. There may be an increased risk of bleeding, so patients taking anticoagulants or medications that affect platelet function should be cautious. If severe skin reactions or symptoms of liver damage occur, stop taking the medication immediately and consult a physician. Pregnant or breastfeeding women should consult a physician before taking this medication, especially in late pregnancy, as side effects may manifest in newborns. It is generally advised not to use this medication in children and adolescents under 18 years old, as its safety and efficacy have not been established. Caution is advised when driving or operating machinery, as dizziness or drowsiness may occur while taking this medication. In case of overdose, seek medical attention immediately, as there is no antidote, and symptomatic treatment should be prioritized.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• depression
• generalized anxiety disorder
• suicidal thoughts
• bruxism
• disorientation

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is also important to keep it at a cool temperature between 15 to 30 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule with the upper part in blue and the lower part in white, containing enteric-coated spherical granules that are white to light brown.

Package unit

28 capsules/PTP