Duloxetine Capsule 30mg (Duloxetine Hydrochloride)

Adult dosage

Adults 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 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 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. 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 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 of more than 60mg once daily is chosen, the dose should be increased in 30mg increments 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. Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, with or without food. A dose of 120mg once daily is safe and effective, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability was reduced at higher doses. For patients with tolerability concerns, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a low dose and gradually increasing it. 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 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. 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. No evidence of additional benefit was 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 considered a chronic condition. In placebo-controlled trials of fibromyalgia treatment, 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. 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. 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. Elderly Dose adjustment based on age is not recommended. However, as with other drugs, caution is required during treatment, particularly because clinical data on the use of the 120mg daily dose are limited. Patients with hepatic impairment Because hepatic impairment may occur, this drug should not be used in patients with liver disease. 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). 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 use, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, the dose may be halved 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. Switching to or from MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor used to treat 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. 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 treatment for 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 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 methylene blue administered by non-intravenous 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: The safety and efficacy of this medicine have not been studied. Therefore, its use is not recommended.

This medication is used for the treatment of depression and other psychiatric disorders. During the course of taking this medication, there may be an increased risk of suicidal thoughts or behavior, particularly in young patients aged 18 to 24, and careful monitoring by a physician is required. There is a risk of serious side effects known as serotonin syndrome, which increases when taken with other serotonin-acting medications. Therefore, this medication should not be used in conjunction with certain drugs, especially MAO inhibitors. Patients with severely impaired liver or kidney function, uncontrolled hypertension, or angle-closure glaucoma should avoid taking this medication. Blood pressure and heart rate should be monitored periodically during treatment, as orthostatic hypotension or syncope may occur. Patients with a tendency for bleeding or those taking anticoagulants should be cautious as the risk of bleeding may be increased. This medication can cause severe skin reactions; therefore, if symptoms such as skin rash, blisters, or mucosal damage appear, it should be discontinued immediately and the physician consulted. Elderly patients, dehydrated individuals, and those taking diuretics may be at risk for hyponatremia, so blood testing should be performed to monitor their condition. If symptoms become severe, it is important to gradually reduce the medication dosage under the supervision of a physician. Caution is needed when driving or operating heavy machinery as dizziness or drowsiness may occur. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may cause side effects in the newborn if taken in late pregnancy. The safety and efficacy of this medication have not been established in children under 18 years of age and it is not recommended for use in this group. In case of overdose, severe symptoms such as coma, seizures, and serotonin syndrome may occur, so immediate emergency treatment is required. Keep out of reach of children and store in the original container to prevent misuse or deterioration.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, reduced libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, muscular dystrophy, feelings of restlessness, irritability, attention deficit, taste disturbances, 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, cardiac arrhythmias, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, burping, gastritis, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzymes, hepatitis, acute liver damage, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, phototoxic reaction, diaphoresis, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, muscle stiffness, dysphagia, pelvic pain, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine 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, elevated serum creatine phosphokinase, increased serum potassium, elevated serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, dribbling, cutaneous vasculitis, microscopic colitis, seizures upon treatment discontinuation, supraventricular arrhythmias, trismus, urticaria, fever, dysphagia, dry skin, hypotension, onychomycosis, worsening depression, emotional swings, suicide attempts, overdose, feelings of restlessness, abnormal dreams, hypersensitivity, hot flashes, pruritus, weight loss, elevated serum bilirubin, intoxication status, hiccups, dyspnea, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, vascular disorders

This medication should be stored in an airtight container to prevent exposure to air and moisture. Additionally, it is important to store it at a cool temperature between 15 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Enteric-coated spherical granules in a blue upper and white lower hard capsule, ranging from white to light brown.

Package unit

28 capsules / PTP