Duloxetine Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1) Adults - 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 them 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 medicine has not been clearly established. Maintenance treatment 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 reassess the patient to determine whether treatment should continue. -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 them 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 of 60mg or more once daily is chosen, it should be increased in 30mg increments 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 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 should periodically reassess the patient to determine whether treatment should continue. -Treatment of diabetic peripheral neuropathic pain Initial treatment This medicine is administered at 60mg once daily, with or without food. It is safe and effective at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. In patients for whom tolerability is a concern, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, starting at a low dose and gradually increasing it should be considered. Maintenance treatment Diabetic peripheral neuropathic pain has a variable course and pain control is empirical; therefore, the effect of this medicine should be evaluated individually. Although efficacy with administration for more than 12 weeks has not been systematically studied in placebo-controlled trials, a 1-year open-label safety study was conducted. -Treatment of fibromyalgia Initial treatment The recommended dose of this medicine is 60mg once daily. To allow patients to adjust to the medication, treatment should be initiated at 30mg once daily for 1 week, 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 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 exceeding 3 months; however, the need to continue treatment should be determined based on each patient's response. -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 to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), doses exceeding 60mg per day provide no additional benefit and are associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this medicine 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 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 (those 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, if possible, rather than abrupt discontinuation. To reduce the risk of withdrawal symptoms when discontinuing after more than 1 week of drug treatment, it is recommended to gradually reduce the dose starting 2 weeks beforehand. During this period, reduce the dose by half or take it 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 a psychiatric disorder and starting treatment with this medicine, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 days should elapse after discontinuing this medicine. 8) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with 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 the benefits of treatment with linezolid or intravenous methylene blue in a particular patient are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued 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 comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, are 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 The safety and efficacy of this drug have not been studied in children and adolescents under 18 years of age. Therefore, use is not recommended.

This drug is primarily used to alleviate symptoms related to depression. During treatment with this medication, especially in younger adults aged 18 to 24, there may be an increased risk of suicidal thoughts or behaviors; therefore, doctors should carefully assess the risks and benefits when prescribing it. Patients of all ages should be closely monitored for signs of suicidal tendencies or abnormal behavioral changes such as aggression and anger after starting treatment, and family members or caregivers should also watch for any unusual signs and consult medical staff immediately if they occur. This medication inhibits the reuptake of neurotransmitters serotonin and norepinephrine to improve symptoms, and in doing so, there is a risk of serious side effects known as serotonin syndrome, so careful monitoring is required if taken with serotonergic drugs or certain psychiatric medications. Furthermore, using this medication in conjunction with MAO inhibitors can be dangerous, so it should not be co-administered for a certain period before and after treatment. Patients with compromised liver function, end-stage renal disease, uncontrolled glaucoma or hypertension, and certain genetic disorders are advised against using this medication. Regular monitoring of blood pressure and heart rate is necessary during treatment because orthostatic hypotension or fainting may occur. There may be an increased risk of bleeding; therefore, patients taking anticoagulants or antiplatelet drugs should exercise caution when using this medication. Suddenly stopping this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; thus, it is recommended to gradually taper the dosage. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is preferable to avoid its use in children and adolescents under 18 as safety and efficacy have not been established. While driving or operating dangerous machinery, symptoms such as dizziness or drowsiness may be present, so caution is advised. In the case of overdose, symptoms such as central nervous system abnormalities, cardiac arrhythmias, and serotonin syndrome may occur, necessitating immediate medical attention.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture. Additionally, it is best to store the medication at room temperature between 15 and 30 degrees Celsius, and not too hot or cold.

Appearance

Enteric-coated spherical granules that are white to light brown inside a blue upper and yellow-green lower hard capsule.

Package unit

28 capsules (14 capsules/PTP X 2)