Duloxetine 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 daily, 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 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 was 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 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 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. It is safe and effective at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. For patients with concerns about tolerability, initiation at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, initiation at a low 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 effects 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, an open-label safety study was conducted for 1 year. 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 at doses exceeding 60mg/day was observed, even in patients who did 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 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 trials exceeding 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 and then increase to 60mg once daily. Administration of doses exceeding 60mg daily to patients who do not respond to the recommended dose (60mg/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 medications, caution is needed during treatment, particularly since 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 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 whenever possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, it is recommended that the dose be gradually reduced starting 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 specific 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 an MAO inhibitor for the treatment of psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor for the treatment of psychiatric disorders and starting treatment with this drug. Conversely, at least 5 days should 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 should not start this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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, in a particular 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. 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 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 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 indications other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts or behaviors in pediatric, adolescent, and young adult patients with depression or psychiatric disorders, therefore physicians should carefully evaluate the necessity and risks of treatment. All patients taking this medication should be closely monitored for abnormal behavioral changes such as symptom worsening, suicidal tendencies, or aggression, and family or guardians should also keep a close watch on the patient. This medication can cause a serious side effect called serotonin syndrome when taken with other serotonin-acting drugs, so it should not be combined with other medications without a doctor's instruction. Particularly, it is prohibited to take it with MAO inhibitors or administer it within a certain period after discontinuation. Patients with severely impaired liver or kidney function, uncontrolled hypertension, or narrow-angle glaucoma, as well as those with certain metabolic disorders of carbohydrates, should not take this medication. Blood pressure and heart rate should be monitored periodically during treatment; patients with hypertension or heart disease should be especially cautious. Orthostatic hypotension or syncope may occur, so care should be taken when experiencing dizziness or lightheadedness. Patients prone to bleeding or taking anticoagulants or medications affecting platelet function should be cautious as the risk of bleeding may be increased. This medication can cause severe skin reactions; if there are skin abnormalities such as rash or blisters, discontinue use immediately and consult a physician. Withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea may occur with sudden discontinuation of the medication, so the dose should be reduced gradually when stopping. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication, and it is also not recommended for nursing mothers. This medication has not been established as safe and effective in pediatric and adolescent patients under 18 years of age, so it is not used in this population. Care must be taken when driving or operating machinery, as dizziness or drowsiness may occur. In cases of overdose, coma, seizures, or serotonin syndrome may occur, necessitating immediate medical attention.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, acute dystonia, akathisia, irritability, attention deficit, taste disturbances, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairments, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac arrhythmias, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, bad breath, stomatitis, bloody stools, elevated liver enzymes, 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 rigidity, myoclonus, trismus, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorders, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, acute pancreatitis, 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, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, headache, drowsiness, dizziness, hypersomnia, tremors, sensory disturbances, acute dystonia, akathisia, irritability, attention deficit, taste disturbances, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairments, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac arrhythmias, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, bad breath, stomatitis, bloody stools, elevated liver enzymes, 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 rigidity, myoclonus, trismus, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorders, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol

This medication should be stored in a tightly closed container to avoid contact with air and moisture. Additionally, it is best to store it at room temperature between 15 to 30 degrees Celsius. This will help maintain the medication's efficacy.

Appearance

An enteric-coated hard capsule with blue upper part and yellow-green lower part containing spherical granules that are white to light brown.

Package unit

28 capsules/PTP