Duloxetine Hydrochloride Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial dose This drug is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started 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 above 60mg per day, and the dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance dose 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 relapse. The physician should periodically reevaluate the patient to determine the need for continued treatment. 2) Treatment of generalized anxiety disorder Initial dose This drug is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow the patient 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 above 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 dose 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 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 dose 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 above 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, starting at a lower dose and gradually increasing it should be considered. Maintenance dose Because the progression of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials, but a 1-year open-label safety study was conducted. 4) Treatment of fibromyalgia Initial dose The recommended dose of this drug is 60mg once daily. To allow the patient to adjust to the medication, treatment should be started 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 dose 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 inadequately responsive to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial dose 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 and then increase the dose to 60mg once daily. In 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 dose 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 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 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 (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, 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 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, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should elapse after discontinuing this drug. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions 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, discontinue this drug immediately and administer linezolid or intravenous methylene blue. Monitor the patient 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 with 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

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 in children and adolescents under 18 years of age. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is primarily used for treating psychiatric disorders associated with depression. Caution is especially needed for young adults and children and adolescents aged 18 to 24, as there may be an increased risk of suicidal thoughts or behaviors. During treatment with this medication, it is important to closely monitor for any unusual behavior changes, such as suicidal thoughts, aggression, or anger, and family members or caregivers should also keep a close eye on the patient. Additionally, this medication can cause severe side effects such as serotonin syndrome, which can be accompanied by symptoms such as changes in mental state, high fever, tremors, seizures, and nausea, posing a potentially emergency situation. When used in combination with other serotonergic agents or certain psychiatric medications, the risk of serotonin syndrome may increase, so consulting a doctor is essential. This medication is not to be administered to certain patients, such as those with hypersensitivity to the active ingredient, those taking MAO inhibitors, patients with liver disease, severe kidney impairment, uncontrolled glaucoma or hypertension. Moreover, caution must be exercised in administering this drug to patients with mania or bipolar disorder, patients with a history of seizures, hypertensive patients, or those with a tendency to bleed. Common side effects after taking this medication include nausea, headache, dry mouth, drowsiness, and dizziness, which mainly occur at the beginning of treatment and ease over time. This medication should not be abruptly discontinued, as withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and tremors may occur. Therefore, it should be tapered off gradually under a doctor's guidance. Pregnant or breastfeeding women should consult a doctor, as the use of this medication may affect the fetus or newborn. It is generally not recommended to use this medication for children and adolescents under 18, as safety and efficacy have not yet been established. Elderly patients can use this drug without a specific dose adjustment, but caution is advised when using higher doses. While taking this medication, caution should be exercised when driving or operating dangerous machinery due to the risk of accidents from drowsiness or dizziness. In case of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, so immediate medical assistance is necessary. Finally, keep out of reach of children and store in the original container to ensure quality is maintained.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is important to store it in a cool place between 15 to 30 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule with a blue upper part and a yellowish-green lower part, containing white enteric-coated spherical granules.

Package unit

30 capsules/bottle, 100 capsules/bottle