Dongkwang Duloxetine Capsule 30 Milligrams (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 once daily, and the dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance treatment In general, a 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 recurrence. The physician should periodically reevaluate 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. Efficacy has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose greater 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 continue treatment with this drug should periodically reevaluate the patient to determine whether continued treatment is necessary. 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 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 it should be considered. Maintenance treatment The course of diabetic peripheral neuropathic pain varies and pain control is empirical; therefore, the effect of this drug should be assessed 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses exceeding 60mg/day, and higher doses are associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is considered a chronic condition. In placebo-controlled trials of treatment for 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 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. In patients who do not respond to the recommended dose (60mg/day), doses exceeding 60mg daily 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 drugs, caution is required during treatment, particularly because clinical data on the use of a dose of 120mg daily 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 necessary 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, if possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of drug therapy, 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 precise approach 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 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, 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 be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is 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 stopped immediately and linezolid or intravenous methylene blue administered. The patient 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 resumed 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 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

Children and adolescents under 18 years of age: This drug 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 drug for conditions other than major depressive disorder have not been studied.

This medication is primarily used to treat psychiatric disorders related to depression. Caution is advised when prescribing this medication to children, adolescents, and young adults aged 18 to 24, as there may be an increased risk of suicidal thoughts or behaviors. Serotonin syndrome, a serious side effect, may occur and includes symptoms such as changes in mental status, high fever, tremors, and seizures. The risk increases when this medication is taken with certain other medications. In particular, it should not be used in conjunction with MAO inhibitors or administered within a certain period after discontinuing them. Patients with impaired liver function or end-stage renal disease, as well as those with uncontrolled hypertension or glaucoma, should not take this medication. Blood pressure and heart rate should be monitored periodically during treatment, as orthostatic hypotension or fainting may occur. In cases of bleeding tendencies or when taking anticoagulants or medications affecting platelet function, caution is also required as the risk of bleeding may increase. Suddenly stopping treatment may cause withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so it is important to gradually reduce the dosage when discontinuing. Pregnant or nursing women should discuss the use of this medication with their doctor, especially late in pregnancy, as there may be side effects for the newborn. Elderly patients may use the medication without dosage adjustment, but caution is necessary with high doses. During treatment, there may be drowsiness or dizziness when driving or operating dangerous machinery, so caution is advised. In case of overdose, there is a risk of coma, tachycardia, serotonin syndrome, and seizures, so immediate medical attention is required. Finally, this medication should be kept out of the reach of children and stored in its original container to prevent degradation.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• depression
• generalized anxiety disorder
• diabetic neuropathic pain
• suicidal thoughts
• bruxism

This medication should be stored in a tightly closed container as it may be sensitive to air or moisture. Additionally, it is important to store it at a temperature between 15 degrees and 30 degrees to maintain its effectiveness.

Appearance

A hard capsule with a blue upper part and a white lower part containing white to light brown delayed-release spherical granules.

Package unit

30 capsules [(10 capsules/PTP) × 3]