Donggwang 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 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 subsided, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine the need for continued treatment. 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 has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose of more than 60mg once daily is selected, 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 the need for continued treatment. 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 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 often occurs as a complication of diabetes, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment The effect of this drug should be evaluated individually because diabetic peripheral neuropathic pain has a variable course and pain control is empirical. Although the efficacy of this drug 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 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 has been observed at doses exceeding 60mg/day, even in patients who do not respond to 60mg, 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 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, then increase the dose to 60mg once daily. For 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 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 dose of 120mg per day are limited. 4. Patients with hepatic impairment This drug should not be used in patients with liver disease because hepatic impairment may occur. 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 whenever 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 over the 2 weeks prior to 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, 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 a psychiatric disorder and starting treatment with this drug, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions 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. 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 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 injection 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

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 conditions other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts or behavior in younger populations with major depressive disorder or other psychiatric conditions, so careful judgment by physicians and close observation by patients and guardians is required. Severe side effects such as serotonin syndrome may occur, so caution is especially necessary when taking this medication in conjunction with other serotonergic drugs, and if symptoms appear, treatment should be discontinued immediately and medical care sought. This drug should not be co-administered with certain medications, particularly MAO inhibitors, so it is essential to avoid co-administration for a certain period before and after use. Patients with severely impaired liver or kidney function, uncontrolled hypertension or glaucoma, and those with certain metabolic disorders should not take this medication. Special precautions are necessary for patients with mania or bipolar disorder, tendencies to bleed, or those on anticoagulants, as well as the elderly. Common side effects such as nausea, headaches, dry mouth, drowsiness, and dizziness may occur, and some patients might experience serious side effects such as suicidal thoughts or actions, liver function abnormalities, and irregular heartbeats, so symptoms should be closely monitored. Discontinuing the medication abruptly may result in withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders, so the dosage should be progressively reduced as directed by a physician. The safety of this medication during pregnancy has not been established, and side effects may appear in newborns, so women who are pregnant or planning to become pregnant should consult a physician. It is a principle not to use this medication in children and adolescents under 18, as safety and efficacy have not been established. During the course of taking this medication, blood pressure and heart rate should be monitored regularly, and if any abnormal reactions such as bleeding symptoms or skin rashes develop, a physician should be notified immediately. Caution is necessary when driving or operating machinery, as dizziness or drowsiness may occur. This medication can interact with several drugs; therefore, if taking other medications, it is crucial to inform a physician or pharmacist. In case of overdose, there is a risk of coma, seizures, or serotonin syndrome, so immediate emergency treatment is necessary. This medication should be stored out of reach of children and keep it 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 thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucination, aggression and anger, hypersomnia, tremors, sensory disturbances, chorea, restless leg syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stools, increased liver enzyme levels, 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, myotonia, mouth opening disorder, dysuria, urinary frequency, nocturia, urinary hesitation, urinary retention, polyuria, decreased urine flow, 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 sensations, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, extrapyramidal disorders, incontinence, cutaneous vasculitis, edema, gastric ulcer, bloody stools, melena, chills, tremors, abnormal sensations, heat sensation, cold sensation, discomfort, decreased blood pressure, limb pain, onychomycosis, vision loss, stupor, chest discomfort, dry skin, increased serum bilirubin, intoxication, overdose, hiccups, dyspnea, trismus, suicide attempt, worsening depression, mood swings, restlessness, delirium, nervous hypersensitivity, agitation, anger, nightmares, suicide, urinary disorders, urinary urgency, enuresis, polyuria, abnormal odor of urine, sexual aversion disorder, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, peripheral coldness

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best to store it in a cool place between 15°C and 30°C.

Appearance

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

Package unit

30 Capsules [(10 Capsules/PTP) × 3]