Duloxetine 60 mg Capsules (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 them 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, the 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 recurrence. 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 them 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 a dose of 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. Consider starting at a lower dose in patients for whom tolerability is a concern. In patients with renal impairment, which is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment Because the progression of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be assessed individually. Although the efficacy of treatment with this drug 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. 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 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 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), doses exceeding 60mg per day provide no additional benefit and are 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 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 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, 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 administer 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 MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 5 days must 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 be started on this drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and 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 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 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 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: This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns regarding safety and efficacy. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This drug is used in the treatment of major depressive disorder, generalized anxiety disorder, pain from diabetic peripheral neuropathy, fibromyalgia, and osteoarthritis pain. When taking this medication, the risk of suicidal thoughts or behaviors may increase, especially in young patients aged 18 to 24, necessitating careful evaluation and ongoing monitoring by a physician. A serious side effect known as serotonin syndrome may arise, so special caution is needed when co-administering this drug with other medications that affect serotonin. This drug may be dangerous when used with certain substances, particularly MAO inhibitors, which should never be taken together, and there should be an adequate time gap between the two. This medication should not be administered to patients with severely impaired liver or kidney function, uncontrolled hypertension, severe glaucoma, or specific sugar metabolism disorders. Blood pressure and heart rate should be monitored regularly during treatment, and extra caution is warranted for individuals with high blood pressure or heart disease. Postural hypotension or fainting symptoms may occur, especially during the initial treatment phase or when increasing the dosage. Due to an increased risk of bleeding, patients taking anticoagulants or medications affecting platelet function should use this drug cautiously. Severe skin reactions, liver damage, or hyponatremia may occur, so any unusual symptoms should prompt immediate consultation with a physician. Abruptly discontinuing this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, and sleep issues, so when stopping, it is essential to gradually reduce the dosage according to a doctor's guidance. Caution is advised when driving or operating machinery as drowsiness or dizziness may occur. Women who are pregnant or breastfeeding should consult a physician before using this medication, and it is not recommended for use in children and adolescents under 18 years. In the event of an overdose, there is a risk of coma, seizures, or serotonin syndrome, necessitating immediate emergency treatment.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremor, paresthesia, dystonia, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, akathisia, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, earache, palpitations, tachycardia, arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive urgency, yawning, pharyngeal stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, bad breath, stomatitis, bloody stools, elevated liver enzymes, hepatitis, acute liver damage, 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, frequency of urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculatory dysfunction, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, lethargy, thirst, abnormal sensation, chills, gait disturbance, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, insomnia, anxiety, sleep disturbance, abnormal dreams, asthenia, sensory disturbances, migraine, taste disturbances, sedation, decreased appetite, dry mouth, vomiting, palpitations, asthenia, headache, tremors, migraine, taste disturbances, sleep disorders, abnormal dreams, orgasmic dysfunction, reduced libido, ejaculatory dysfunction, penile dysfunction, cough, sore throat, sweating, rash, itching, facial flushing, seasonal allergies, upper respiratory infection, urinary tract infection, influenza, gastroenteritis virus, weight gain, musculoskeletal pain, muscle spasm, headache, dizziness, drowsiness, tremors, sensory disturbances, migraine, taste disturbances, insomnia, anxiety, sleep disturbance, abnormal dreams, orgasmic dysfunction, reduced libido, ejaculatory dysfunction, penile dysfunction, cough, sore throat, sweating, rash, itching, facial flushing, palpitations, dizziness, tinnitus, hypothyroidism, blurred vision, diplopia, decreased vision, bloating, belching, gastritis, bad breath, stomatitis, gastric ulcer, bloody stools, melena, chills, tremors, abnormal sensation, warmth, coldness, bodily discomfort, thirst, gait disturbance, gastroenteritis, laryngitis, weight gain, increased serum cholesterol levels, dehydration, hyperlipidemia, dyslipidemia, musculoskeletal pain, muscle rigidity, muscle cramps, taste disorders, weakness, sensory disturbances, sensory loss, attention deficit, dyskinesia, dystonia, poor sleep quality, speech disorders, abnormal dreams, sleep disturbances, apathy, bruxism, loss of directional sense, confusion, irritability, severe mood swings, suicide attempts, suicide, urination disorders, urgency in urination, nocturnal enuresis, polyuria, abnormal odor of urine, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat constriction, facial flushing, flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, aggression and anger, angioedema, erythema multiforme, extrapyramidal disorders, delirium, glaucoma, cutaneous vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive urgency, microscopic colitis, muscle cramps, rash, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, anxiety, stupor, chest discomfort

This medication can degrade due to air or moisture, so it should be stored in a sealed container. Additionally, it is advisable to keep it in a cool temperature between 15°C and 30°C.

Appearance

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

Package unit

28 capsules/PTP