Yuyu Duloxetine Capsule 30 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 the patient to adjust to the medication, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses of this drug exceeding 60mg daily, 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, it is recommended that medication be continued for several months 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 the patient to adjust to the medication, and then increased to 60mg once daily. Although efficacy has been 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 chosen, the dose 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, 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 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 was reduced 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, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because diabetic peripheral neuropathic pain varies in its progression and pain control is empirical, the effect of this drug should be assessed individually. The efficacy of administration of this drug for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, 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 of this drug exceeding 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. The efficacy of this drug in placebo-controlled trials for the treatment of fibromyalgia 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, then increase the dose to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), administration of doses exceeding 60mg daily 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 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 needed during treatment, particularly because clinical data on the use of a dose of 120mg daily 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 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 (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 starting 2 weeks before discontinuation to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken every other day. However, the exact method should be determined based on the individual patient's circumstances, such as 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 treatment with an MAO inhibitor for the treatment of psychiatric disorders and starting treatment with this drug, at least 14 days should elapse between treatments. Conversely, when starting treatment with an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should elapse after discontinuing this drug. 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 requiring other interventional procedures, including hospitalization, or more urgent treatment of a 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 there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome until 5 days after administration of linezolid or intravenous methylene blue, or 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 with intravenous administration of this drug at doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Children's dosage

3. 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 mainly used to treat psychiatric disorders related to depression and is not recommended for children and adolescents as safety has not been established. During the use of this medication, there may be an increase in suicidal thoughts or behaviors; therefore, young adults aged 18 to 24 should be closely monitored. Serotonin syndrome, a serious side effect, may occur, which includes various symptoms such as changes in mental state, high fever, muscle spasms, and seizures, so immediate consultation with a healthcare provider is essential if these symptoms appear. There may be dangerous interactions if this medication is taken with certain drugs, especially monoamine oxidase inhibitors (MAOIs), so concomitant use should be avoided. Patients with severely impaired liver or kidney function, uncontrolled hypertension, or glaucoma should avoid using this medication. Blood pressure and heart rate should be monitored periodically during treatment, and if blood pressure rises or heart rate increases, the patient should consult a doctor. Orthostatic hypotension and fainting may occur, so caution is advised when starting to take the medication or increasing the dosage. Patients with bleeding tendencies or those taking anticoagulants or drugs affecting platelet function should be cautious as bleeding risk may increase. If serious skin reactions such as rash, blisters, or mucosal damage occur during treatment, the medication should be discontinued immediately, and the healthcare provider should be informed. Abruptly stopping the medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, and anxiety, so the dosage should be gradually reduced per doctor’s instructions. Caution is needed when driving or operating hazardous machinery, and activities should be avoided if drowsiness or dizziness occurs. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and those who are breastfeeding should also be cautious as some drugs may be transferred into breast milk. Overdose can lead to serious symptoms such as coma, seizures, and serotonin syndrome, so immediate emergency treatment is necessary. Keep out of reach of children and store the medication in its original container to maintain quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorder, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremor, sensory abnormalities, akathisia, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertension-induced eruption, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzyme levels, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, mouth-opening disorder, dysuria, frequent urination, nocturia, hesitancy, urinary retention, polyuria, decreased urinary flow rate, 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 feelings, chills, gait disturbance, weight loss, weight gain, increased serum creatine phosphokinase, hyperkalemia, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, extrapyramidal disorder, polysomnography, cutaneous vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reaction, hypertension-induced eruption, microscopic colitis, muscle cramping, seizures upon discontinuation, supraventricular arrhythmia, trismus, urticaria, increased appetite

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 degrees and 30 degrees Celsius.

Appearance

A hard capsule containing delayed-release spherical granules that are white to light brown, with a blue upper part and a white lower part.

Package unit

30 capsules (10 capsules/PTPX3)