Droxetine Capsule 60 mg (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, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses exceeding 60mg daily, 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 recurrence. The physician should periodically re-evaluate 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, 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, 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 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 use of this drug should periodically re-evaluate 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. For patients with tolerability concerns, 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 Because diabetic peripheral neuropathic pain varies in its progression and pain control is empirical, the effect of this drug should be evaluated 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 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 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 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. Administration of doses exceeding 60mg daily to patients who do not respond to the recommended dose (60mg/day) provides no additional benefit and is 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 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 daily 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 (those 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 treatment is discontinued after more than 1 week of medication use, it is recommended that the dose be gradually reduced beginning 2 weeks before discontinuation 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 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 this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration 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, 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 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection) or intravenous administration of this drug at 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 This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years. 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 psychiatric disorders related to depression and alleviates symptoms by inhibiting the reuptake of neurotransmitters serotonin and norepinephrine. In children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors, so doctors should carefully assess the risks and benefits when administering it to patients in this age group. During treatment with this medication, abnormal behavioral changes such as suicidal thoughts, aggression, and anger should be closely monitored, and family members or caregivers should also closely observe the patient's condition. Serotonin syndrome, a serious side effect, may occur, so caution is especially needed when used in combination with other serotonergic drugs. It is prohibited to take it in combination with MAO inhibitors or to switch within a certain period, and it should be taken according to the doctor's instructions. It should not be administered to patients with impaired liver function or end-stage renal disease, uncontrolled glaucoma, or hypertension. Blood pressure and heart rate should be regularly monitored during the intake of this drug, and if symptoms of orthostatic hypotension or fainting occur, medical consultation should be sought immediately. Patients with bleeding tendencies or those taking anticoagulants or medications affecting platelet function should be cautious as the risk of bleeding may increase. If severe skin reactions such as rashes, blisters, or mucosal damage occur, the medication should be stopped immediately, and medical personnel should be notified. Abrupt discontinuation of treatment may lead to withdrawal symptoms such as dizziness, sleep disturbances, and anxiety, so it is safer to gradually reduce the dosage when stopping. Caution should be taken due to the possibility of dizziness or drowsiness when driving or operating dangerous machinery. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, and especially in late pregnancy, there is a risk of adverse effects on the newborn. For the elderly, although general dosage adjustments are not recommended, careful observation is required. In case of overdose, coma, seizures, or serotonin syndrome may occur, necessitating immediate emergency treatment. The safety and efficacy of this medication have not been established in children, therefore it should not be administered to those under 18 years of age.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• depression
• generalized anxiety disorder
• suicidal thoughts
• suicidal behavior
• insomnia

This medication should be stored in an airtight container that is well-ventilated, and it is important to maintain a storage temperature between 15°C and 30°C in a room. By storing it this way, the effectiveness of the medication can be maintained for a long period.

Appearance

A hard capsule with a blue upper part and a yellow-green lower part containing enteric-coated pellets that are white to light yellow.

Package unit

30 capsules/bottle, 200 capsules/bottle