Duloxetin 30 mg Capsule (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, 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 have improved, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine whether continued treatment is necessary. 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, 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 greater than 60mg once daily is selected, it 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 necessary. 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 decreased at higher doses. A lower starting dose may be considered for patients with concerns about tolerability. For patients with renal impairment, which is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. 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. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, 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 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 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), administering doses exceeding 60mg per day offers 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 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 before discontinuation is recommended to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken 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 MAO inhibitors used to treat psychiatric disorders At least 14 days should elapse after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 5 days should elapse after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. 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 other interventional procedures, including hospitalization, or treatment for a more urgent psychiatric condition, 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 medication to linezolid or intravenous methylene blue is available and, for a specific patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be stopped 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 nonintravenous 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 such use.

Children's dosage

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 indications other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts or actions in younger patients (ages 18-24) with major depressive disorder or psychiatric disorders; therefore, the physician should carefully assess the need and risks of treatment. All patients taking this medication should be closely monitored for worsening of disease or unusual behavioral changes such as thoughts of suicide, aggression, etc., and family members or guardians should also observe closely. This medication can cause serious side effects known as serotonin syndrome, which may present with symptoms such as confusion, high fever, tremors, and seizures; if such symptoms occur, immediate medical attention must be sought. Combining this medication with other serotonergic drugs or MAO inhibitors is dangerous and should be discussed with a physician; especially, combination therapy is contraindicated. This medication should not be administered to patients with liver dysfunction, end-stage renal disease, uncontrolled glaucoma, or hypertension. During treatment, blood pressure and heart rate should be monitored periodically, as there may be increased blood pressure, orthostatic hypotension, or symptoms of fainting. Patients with a tendency to bleed or those taking anticoagulants or medications affecting platelet function should be closely monitored for increased risk of bleeding. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, or nausea, so the dosage should be gradually reduced according to a physician’s instructions. Women who are pregnant or breastfeeding should consult a physician before taking this medication, especially near the end of pregnancy, as side effects may occur in newborns. The use of this medication is generally not recommended for children and adolescents under 18, as the safety and efficacy have not been established. Side effects such as drowsiness, dizziness, dry mouth, headache are common, so caution is needed when taking this medication and when driving or operating dangerous machinery. In case of overdose, symptoms such as coma, seizures, serotonin syndrome may occur, requiring immediate emergency intervention. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or degradation of quality.

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

Store this medication in a tightly closed container to protect it from air or moisture and keep it at room temperature between 15 and 30 degrees Celsius.

Appearance

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

Package unit

28 capsules/PTP (14 capsules/PTP X 2)