PMS Duloxetine Capsule 30mg (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 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 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 improve, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine whether continued treatment is needed. 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 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 above 60mg once daily is selected, the dose 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 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 use this drug for an extended period should periodically reassess the patient to determine whether continued treatment is needed. 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 decreased at higher doses. For patients with concerns about tolerability, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment As diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this drug should be assessed individually. Although the efficacy of administration 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. No evidence of additional benefit has been observed at doses exceeding 60mg/day, even in patients who do not respond to 60mg, 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 treatment for fibromyalgia, the efficacy of this drug was observed for up to 3 months. Efficacy of Cymbalta was not observed in long-term trials lasting more than 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 per day provide no additional benefit and are 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 Dosage 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 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 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 (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 beforehand to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take it every other day. However, the exact 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 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, before starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should have elapsed after discontinuation of this drug. 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 who require other interventions, including hospitalization, to treat 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 alternatives to linezolid or intravenous methylene blue are available, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or with intravenous administration of this drug at a dose 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

3. Children and adolescents under 18 years of age This medicine must 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 conditions other than major depressive disorder have not been studied in this age group.

This medication is used for treating depression and psychiatric disorders, and particularly in the young population aged 18 to 24, there may be an increased risk of suicidal thoughts and behaviors necessitating careful observation. During the course of this medication, severe side effects such as serotonin syndrome may occur, which includes changes in mental status, high fever, tremors, seizures, etc., and other serotonin agents should not be combined without consulting a doctor. This medication should not be co-administered with certain medications, especially monoamine oxidase inhibitors (MAOIs), as it can be dangerous. Patients with severe liver or kidney dysfunction, uncontrolled high blood pressure, or glaucoma should avoid taking this medication. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur during treatment and typically resolve over time. Stopping this medication abruptly may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, hence the dosage should be gradually reduced under a doctor's guidance. Blood pressure may increase and heart rate may rise, so patients with hypertension or heart disease should check their blood pressure regularly, and anticoagulant users should take caution due to bleeding risk. This medication may cause severe skin reactions or liver damage; therefore, if a rash or jaundice symptoms appear, the doctor should be notified immediately. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is generally not used in children and adolescents under 18 years of age. Drowsiness or dizziness may occur during driving or operating machinery, requiring caution, and in the event of overdose, severe symptoms such as coma or seizures may appear, necessitating immediate emergency treatment. This medication has many interactions with other drugs, so it is essential to inform the doctor or pharmacist about any other medications being taken, especially when combined with alcohol or sedatives.

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

This medication should be stored in a tightly closed container, protected from air and humidity. The recommended storage temperature is between 15 to 30 degrees Celsius. This helps maintain the drug's efficacy and safety.

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.

Package unit

28 Capsules/PTP