Sevatacapsule 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 adaptation to the medication, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses above 60mg per day, 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 have improved, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reassess the patient to determine the need for continued treatment. 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 adaptation 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 above 60mg. Nevertheless, if a dose of 60mg or more once daily is selected, the dose should be increased in increments of 30mg once daily. The safety of doses above 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 treatment with this drug should periodically reassess the patient to determine the need for continued treatment. 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 above 60mg. Tolerability was reduced at higher doses. In patients for whom tolerability is a concern, initiation at a lower dose may be considered. For patients with renal impairment, which often occurs as a complication of diabetes, initiation at a lower dose followed by gradual dose increases should be considered. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, 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 adapt 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 above 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 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 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 adapt 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), administration of doses above 60mg per day provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of administration 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 medications, 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 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 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 the medication 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 or to an MAO inhibitor 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 must be allowed. Conversely, at least 5 days must elapse 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 preparations should not start this drug because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or an intravenous methylene blue preparation are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or an intravenous methylene blue preparation administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days after administration of linezolid or an intravenous methylene blue preparation, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or an intravenous methylene blue preparation. The risk associated with administration of methylene blue by non-intravenous routes (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 acute symptoms of serotonin syndrome with these uses.

Children's dosage

Children and adolescents under 18 years of age: Due to concerns about safety and efficacy, this drug should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this drug for indications other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts or behaviors in younger adults with major depressive disorder or psychiatric conditions, so careful monitoring is necessary when administering it, especially to children, adolescents, and young adults. This medication can cause a serious side effect known as serotonin syndrome, which includes symptoms such as changes in mental state, high fever, tremors, and seizures and the risk increases when used in combination with other serotonin-acting medications. This medication should not be taken with certain MAO inhibitors and should not be administered to patients with severely impaired liver or kidney function, uncontrolled hypertension, or narrow-angle glaucoma. Blood pressure and heart rate should be checked periodically during treatment, especially in patients with hypertension or heart disease. Orthostatic hypotension or fainting may occur, so patients should move slowly and monitor for symptoms when initiating therapy or adjusting the dose. Patients taking anticoagulants or medications that affect platelet function should be cautious as there is an increased risk of bleeding. Severe skin reactions or allergic reactions may occur, so if symptoms such as skin rash, fever, or mucosal damage appear, the medication should be stopped immediately and a doctor consulted. Suddenly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, drowsiness, and nausea; therefore, the dose should be gradually reduced under the supervision of a doctor. Caution is advised when driving or operating dangerous machinery as dizziness or drowsiness may occur. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and nursing mothers are advised to avoid breastfeeding as small amounts may be excreted in breast milk. The safety and efficacy of this medication for children and adolescents under 18 years have not been established, and it is recommended not to administer it to them. In case of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, requiring immediate emergency treatment; there is no antidote, thus professional medical treatment is necessary. This medication should be kept out of reach of children and stored in its original container to prevent degradation in quality.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 15 to 30 degrees Celsius. This will help preserve the effectiveness and safety of the medication for a long time.

Appearance

A hard capsule with a blue upper part and a white lower part containing spherical gastro-resistant granules that are white to grayish-white.

Package unit

28 capsules/box [14 capsules/PTP*2]