Duloxetine 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 started at 30mg once daily for 1 week to allow them to adjust to the medication, and 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, 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 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 started at 30mg once daily for 1 week to allow them to adjust to the medication, and 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 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 considered 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 elect to continue 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. For patients with concerns about tolerability, 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 may be considered. Maintenance treatment Diabetic peripheral neuropathic pain varies in its progression, and pain control is empirical; therefore, the effect of this drug should be assessed individually. Although the efficacy of treatment with 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 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 treatment Fibromyalgia is considered 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 and then increase the dose to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), administering doses exceeding 60mg per 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 treatment of osteoarthritis pain with administration for more than 13 weeks have not been studied. 2. Older adults Dosage adjustment based on age is not recommended. However, as with other medications, caution is needed during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. 4. Patients with hepatic impairment As 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 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 medication use, gradual dose reduction starting 2 weeks beforehand is recommended to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take it every other day. However, the exact method should be determined by considering 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, an interval of at least 14 days should be allowed. Conversely, at least 5 days must have elapsed after discontinuing this drug before starting an MAO inhibitor for the treatment of 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 who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment 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 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 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 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 Because of concerns regarding safety and efficacy, this medication should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medication for indications other than major depressive disorder have not been studied.

This medication is used to treat various conditions such as major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. This drug can increase the risk of suicidal thoughts and behaviors, especially in children, adolescents, and young adults, so the risks and benefits should be carefully considered when prescribing to this age group. Serotonin syndrome, a serious side effect, can occur and the risk is higher when used in combination with other serotonergic drugs. This medication can be dangerous when used with certain drugs, especially it should never be taken together with MAO inhibitors. It is safer not to administer this medication to patients with severely impaired liver or kidney function, uncontrolled glaucoma, or hypertension. Particular caution is necessary for patients with mania or bipolar disorder, those with a tendency for bleeding, the elderly, and those who are dehydrated. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur during treatment, and these symptoms usually start at the beginning of therapy and gradually diminish. Abrupt discontinuation of this medication may cause withdrawal symptoms such as dizziness, sensory disturbances, insomnia, fatigue, and anxiety, so it is important to taper off the medication gradually. This medication may cause increased blood pressure and heart rate, so patients with hypertension or heart disease should regularly monitor their blood pressure and heart rate. There may be an increased risk of bleeding, so patients taking anticoagulants or drugs affecting platelet function should be cautious. Severe skin reactions may occur, so any signs of rash, blisters, or mucosal damage should prompt immediate discontinuation and consultation with a physician. Women who are pregnant or planning to become pregnant should consult a physician, and it is not recommended to use while breastfeeding as small amounts may be excreted in breast milk. The safety and efficacy of this medication have not been established in children, so it should not be used in individuals under 18 years of age. In cases of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, requiring immediate emergency treatment. Store this medication out of the reach of children and keep it in its original container to prevent deterioration of quality. This medication may affect psychomotor function, so caution is required when driving or operating dangerous machinery.

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

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it is best to store it at room temperature between 1 degree and 30 degrees Celsius. Avoid storing it in excessively hot or cold places.

Appearance

White round enteric-coated film-coated tablet

Package unit

30 tablets/bottle