Yuyu Duloxetine Capsule 60mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This medication 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 medication has not been clearly established. Maintenance treatment In general, response to antidepressant treatment begins to appear after 2~4 weeks. 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 medication 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 medication 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 medication should periodically reassess the patient to determine the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medication is administered at a dose of 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 often occurs as a complication of diabetes, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this medication should be assessed individually. Although the efficacy of this medication 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 medication 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. 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 known to be a chronic condition. In placebo-controlled trials of treatment for fibromyalgia, the efficacy of this medication 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 medication 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 medication 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 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 Because hepatic impairment may occur, this medication 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 medication 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 medication, gradual dose reduction over at least 1~2 weeks is recommended whenever possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, it is recommended to gradually reduce the dose starting 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 method should be determined by considering the patient's individual circumstances, including 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 an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days must have elapsed since discontinuation of this medication. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients who require treatment of 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 medication. 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 medication may be stopped immediately and linezolid or intravenous methylene blue administered. The patient 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 comes first. Treatment with this medication 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 non-intravenous route (oral tablets or local injection), or with intravenous administration of this medication 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

Children and adolescents under 18 years of age Because of concerns about safety and efficacy, this medicine should 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.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Therefore, when administering to patients in this age group, the physician must carefully consider the risks and benefits, and patients and guardians should closely monitor the patient's condition. This medication can cause a serious side effect known as serotonin syndrome, which includes changes in mental state, high fever, tremors, seizures, and vomiting. The risk of serotonin syndrome may increase when used in combination with other serotonergic drugs, so caution is required. This medication should not be used with certain drugs, especially MAO inhibitors, as it can lead to life-threatening side effects. It should not be administered to patients with liver disease, end-stage kidney disease, uncontrolled hypertension, or glaucoma, and should be avoided in cases of hypersensitivity to this medication. Caution is advised in patients with a history of mania, bipolar disorder, epilepsy, or renal impairment, as well as in elderly patients. Common side effects of this medication may include nausea, headache, dry mouth, drowsiness, and dizziness, while serious side effects, including suicidal thoughts or behavior, liver damage, and heart irregularities, have also been reported. Stopping treatment abruptly can result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it is important to taper the dose gradually. Blood pressure and heart rate should be monitored regularly during treatment, and caution should be exercised when combined with anticoagulants or drugs affecting platelet function due to the risk of bleeding. Caution is also needed when driving or operating dangerous machinery due to the possibility of dizziness or drowsiness. Safety during pregnancy has not been established, and particularly in late pregnancy, neonates may exhibit withdrawal symptoms, so use during pregnancy should be considered carefully. It is not recommended during breastfeeding as this medication may be excreted in breast milk and can affect infants. Safety and efficacy in children under 18 years have not been established, and it should be used in elderly patients with caution but without special dosage adjustment. In cases of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, and immediate medical attention is required. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration of quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, laryngitis, anaphylactic reaction, hypersensitivity disorder, hypothyroidism, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, reduced libido, anorgasmia, agitation, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, somnolence, tremors, sensory disturbances, myoclonus, restlessness, hypersensitivity, attention deficit disorder, taste abnormalities, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, supraventricular arrhythmias, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertension-induced symptoms, 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, muscle twitching, trismus, dysuria, frequent urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopause symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, malaise, thirst, abnormal sensation, chills, gait disturbances, weight loss, weight gain, elevated serum creatine phosphokinase, hyperkalemia, elevated serum cholesterol, acute pancreatitis, erythema multiforme, cutaneous vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, microscopic colitis, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, dysphagia, dry skin, decreased blood pressure, limb pain, onychomycosis, visual impairment, stupor, chest discomfort, fever, anxiety, halitosis, gastric ulcer, head discomfort, burning sensation, mental retardation, depression, elevated serum bilirubin, drug intoxication, hiccups, dyspnea, restlessness, abnormal dreams, worsening depression, emotional fluctuations, suicide attempts, overdose, increased appetite

This medication must 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.

Appearance

A blue hard capsule with a yellow-green lower half containing enteric-coated spherical granules that are white to light brown in color

Package unit

30 capsules (10 capsules/PTP x 3)