Sébata 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 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 have improved, continued medication use for several months is recommended to prevent relapse. The physician should periodically reevaluate 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 greater than 60mg once daily is chosen, 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, i.e., 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 reevaluate 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 it is safe and effective at 120mg once daily, 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 Because diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this drug should be evaluated individually. Although the efficacy of this drug when administered 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 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 studies lasting more than 3 months; however, the need for continued treatment should be determined based on each individual 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. In patients who do not respond to the recommended dose (60mg/day), administration of 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 when administered for more than 13 weeks for the treatment of osteoarthritis pain have not been studied. 2. Elderly patients Dose adjustment based on age is not recommended. However, as with other drugs, 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 required 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, gradual dose reduction beginning 2 weeks before discontinuation is recommended 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 MAOIs used to treat psychiatric disorders At least 14 days should elapse between discontinuation of an MAOI used to treat psychiatric disorders and initiation of treatment with this drug. Conversely, at least 5 days should elapse after discontinuation of this drug before starting an MAOI for the treatment of psychiatric disorders. 8. Other MAOIs, 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, 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 alternative to linezolid or intravenous methylene blue is available and, for a specific 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 methylene blue administered by a non-intravenous 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 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 is used for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, etc. During treatment with this drug, there may be an increase in suicidal thoughts or behaviors, so young adults and adolescents, especially those aged 18 to 24, should be closely monitored. Additionally, this drug can potentially cause a life-threatening condition known as serotonin syndrome, so special caution is needed when used in conjunction with serotonin-active medications. Do not take this medication in conjunction with certain types of antidepressants or antipsychotics, or MAO inhibitors. Patients with severely impaired liver or kidney function, untreated hypertension, or glaucoma should not use this medication. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur, and most are initial symptoms that improve over time. If this medication is suddenly stopped, withdrawal symptoms such as dizziness, sensory abnormalities, and sleep disturbances may occur, so the dosage should be gradually reduced under a doctor's guidance. Blood pressure may rise and heart rate may increase, so patients with hypertension should regularly monitor their blood pressure and consult a doctor if there are any abnormal symptoms. Patients with a tendency to bleed or taking medications that affect blood coagulation should be careful as there may be an increased risk of bleeding. Severe skin reactions may also occur; if skin rashes, blisters, or mucosal abnormalities appear, discontinue use immediately and consult medical personnel. Elderly patients, patients with dehydration, or patients taking diuretics are at higher risk of developing hyponatremia and should be cautious. This medication may pose potential risks to the fetus during pregnancy, so women who are pregnant or planning to become pregnant should consult a doctor, and nursing mothers are also advised against use. Safety for children and adolescents has not been established, and it is generally not administered to them. Caution is required when driving or operating machinery due to symptoms like dizziness or drowsiness. In case of overdose, coma, seizures, or serotonin syndrome may occur, and immediate emergency treatment should be sought. This medication should be kept in its original container and stored in a place out of reach of children.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, laryngitis, anaphylactic reaction, hypersensitivity, hypothyroidism, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, teeth grinding, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggression and anger, stupor, tremors, sensory disturbance, dystonia, akathisia, neurobehavioral hyperreactivity, attention deficit, taste disturbance, movement disorder, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac arrhythmias, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive urgency, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myoclonus, trismus, dysuria, frequent urination, nocturia, urine hesitation, urine retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, malaise, thirst, abnormal sensations, chills, gait disturbance, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, acute pancreatitis, erythema multiforme, cutaneous vasculitis, edema, decreased blood pressure, onychomycosis, worsening depression, mood swings, suicide attempts, overdose, intoxication, hiccups, dyspnea, trismus

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The appropriate storage temperature is in a cool place between 15 degrees and 30 degrees.

Appearance

A hard capsule consisting of white to grayish-white enteric-coated spherical granules, with a blue upper part and a yellow-green lower part.

Package unit

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