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 exceeding 60mg per day, and the dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance treatment In general, 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 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. Efficacy has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose above 60mg once daily is selected, 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, 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 decreased at higher doses. For patients with tolerability concerns, starting at a lower dose may be considered. In patients with renal impairment, which often occurs as a complication of diabetes, starting at a lower dose and gradually increasing it may be considered. 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 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 trial 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 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 to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), administering 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 for administration exceeding 13 weeks for the treatment of osteoarthritis pain have not been studied. 2. Elderly 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 (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 drug therapy, gradual dose reduction starting 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 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 MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of a psychiatric disorder, at least 5 days should have elapsed 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 treatment of a more urgent psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to patients 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. 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (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

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 can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses, so it should be administered cautiously by physicians for patients in this age group. All patients taking this medication should be carefully monitored for abnormal behavior changes such as worsening depression, suicidal thoughts, aggression, and anger, and family members or caretakers should closely observe the patient. Serotonin syndrome, a serious side effect, may occur, which includes symptoms of altered mental status, high fever, tremors, seizures, nausea, and vomiting. Caution is especially needed when taking this medication with certain other drugs. This medication should not be taken with MAO inhibitors, and treatment should not be initiated until a certain period after stopping these medications. Patients with severely impaired liver or kidney function, uncontrolled glaucoma or hypertension should avoid taking this medication. Patients with a history of mania or bipolar disorder, epilepsy, bleeding tendencies, those taking anticoagulants, or elderly patients should be monitored closely while taking this medication. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur mainly at the beginning of treatment and generally lessen over time. Suddenly stopping this medication can cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors, so patients should gradually taper the dose under a doctor's guidance. This medication may cause an increase in blood pressure and heart rate, so patients with hypertension or heart disease should regularly check their blood pressure. Orthostatic hypotension and fainting symptoms may occur, especially at the beginning of treatment and during dose escalation, so caution is required. There may be an increased risk of bleeding, so patients taking anticoagulants or drugs affecting platelet function should be careful. Severe skin reactions may occur, so if symptoms such as rash, blisters, or mucosal lesions appear, discontinue use immediately and consult a doctor. There is a risk of developing hyponatremia, so elderly patients, dehydrated patients, and those taking diuretics should be cautious of symptoms. This medication may increase urethral resistance, leading to difficulties in urination, so if urinary difficulties occur, notify a physician. Psychomotor side effects such as restlessness may occur, and dose adjustments may be necessary if such symptoms appear. Liver dysfunction and hepatitis have been reported, so patients with liver disease require regular liver function tests. Dizziness or drowsiness may occur while driving or operating dangerous machinery, so caution is advised. There may be potential interactions with other medications, particularly central nervous system drugs, MAO inhibitors, and serotonergic drugs, so always consult with a physician before use. During pregnancy, there may be risks to the fetus, so inform the doctor of any plans to become pregnant or confirm pregnancy, and it is not recommended during breastfeeding. It is advisable not to use in children and adolescents under 18 years of age as safety and efficacy have not been established for indications other than major depressive disorder. Overdose may cause coma, seizures, serotonin syndrome, etc., so if suspected, seek medical attention immediately. This medication should be kept out of the reach of children and stored in its original container for safety.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, drowsiness, tremors, sensory disturbances, myoclonus, 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, ventricular arrhythmias, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive emergencies, yawning, throat stiffness, nosebleeds, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastritis, belching, gastric ulcer, difficulty swallowing, halitosis, stomatitis, bloody stools, elevated liver enzyme levels, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reactions, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myopathy, jaw opening restriction, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation problems, 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, insomnia, anxiety, abnormal dreams, asthenia, restlessness, irritability, nightmares, suicide attempts, depression, hypersensitivity reactions, decreased blood pressure, onychomycosis, dry skin, difficulty swallowing, fever, delirium, chest discomfort, hyperhidrosis, palpitations, emotional instability, exacerbation of depression, weight gain, elevated ALT, elevated AST, halitosis, gastric ulcer, gastritis, abdominal pain, hypersomnia, discomfort in the head, taste disturbances, burning sensation, mental retardation, delirium, nervousness, restlessness, anger, increased serum bilirubin, intoxication, hiccups, respiratory distress, restlessness, abnormal dreams, exacerbation of depression, emotional instability, suicide attempts, overdose, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal disorders, hyperhidrosis, cutaneous vasculitis, hallucinations, hyperglycemia, hyperprolactinemia, hypertensive emergencies, microscopic colitis, muscle cramps, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmias, difficulty opening mouth, urticaria

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

A hard capsule with blue upper part and white lower part containing white to light brown enteric-coated spherical granules.

Package unit

28 capsules/PTP