Duloxetine Hydrochloride Capsule 60 mg

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This drug is administered at a dose of 60mg once daily, regardless of meals. 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, 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 relapse. The physician should periodically reevaluate 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, regardless of meals. 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 of 60mg or more 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 reevaluate 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, regardless of meals. 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. Consider starting at a lower dose in patients for whom tolerability is a concern. For 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 course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, 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 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 use 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 of fibromyalgia treatment, the efficacy of this drug was observed for up to 3 months. 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), 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 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 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 (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, if possible, rather than abrupt discontinuation. When discontinuing treatment after more than 1 week of medication use, gradual dose reduction starting 2 weeks beforehand is recommended 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. 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 should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days must 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 be started on this drug because of the increased risk of serotonin syndrome. For patients requiring other interventions, including hospitalization, or more urgent treatment for a psychiatric condition, 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. 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 a non-intravenous route (oral tablet or local injection) or intravenous administration of this drug at 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 drug 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 drug for indications other than major depressive disorder have not been studied.

This drug is primarily used to treat psychiatric disorders associated with depression. There may be an increased risk of suicidal thoughts or behaviors during treatment, so young patients, especially those aged 18 to 24, should be closely monitored. This medication is not approved for use in children and adolescents, and if administered to patients in this age group, suicidal symptoms or changes in behavior should be closely monitored. Serotonin syndrome, a serious side effect, may occur. This can be accompanied by various symptoms such as changes in mental state, high fever, tremors, seizures, and vomiting, and the risk is increased when this drug is taken with certain other medications (e.g., MAO inhibitors, triptans, lithium, etc.). The concomitant use of this drug with MAO inhibitors is prohibited. This medication should not be used in patients with impaired liver function, end-stage kidney disease, uncontrolled hypertension, or angle-closure glaucoma. Patients with certain genetic diseases like fructose intolerance should also avoid its use. Patients with a history of mania, bipolar disorder, epilepsy, or bleeding tendencies, older adults, and those on diuretics should exercise caution when using this drug, and be aware of potential side effects such as hyponatremia, elevated blood pressure, bleeding risk, and liver damage. Common side effects of this drug include nausea, headache, dry mouth, drowsiness, and dizziness, which usually occur early in treatment and diminish over time. Sudden discontinuation may cause withdrawal symptoms such as dizziness, sensory disturbances, insomnia, anxiety, and nausea, so dosage should be gradually reduced. During treatment, blood pressure and heart rate should be monitored regularly, and medical attention should be sought immediately if bleeding symptoms occur. In addition, if severe skin reactions or signs of hepatitis occur, the medication should be discontinued immediately and healthcare providers notified. Patients who are pregnant or nursing should consult a doctor before taking this medication, as taking it in late pregnancy may lead to withdrawal syndrome in newborns. This drug has not been established as safe and effective for use in pediatric patients under 18 years of age. In case of overdose, severe symptoms such as coma, seizures, and serotonin syndrome may occur, so dosage must be strictly adhered to, and immediate emergency treatment should be sought in case of overdose. This medication should be stored out of reach of children and kept in the original container to prevent quality deterioration. Caution is necessary when driving or operating heavy machinery as drowsiness or dizziness may occur. Interactions may occur when this drug is taken with specific medications (e.g., MAO inhibitors, strong CYP1A2 inhibitors, anticoagulants, etc.), so patients must inform healthcare providers of any other medications they are taking.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, appetite loss, 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, hypersomnia, tremor, paresthesia, focal segmental glomerulosclerosis, akathisia, irritability, attention deficit disorder, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, ventricular arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, fainting, hypertensive emergencies, yawning, pharyngeal stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzymes, 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, muscle twitching, opening disorder, dysuria, pollakiuria, nocturia, urinary hesitancy, urinary retention, polyuria, reduced urinary 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, malaise, thirst, abnormal feelings, chills, gait disturbances, weight loss, weight gain, elevated serum creatine phosphokinase, elevated serum potassium, elevated serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, cutaneous vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, microscopic colitis, restless legs syndrome, seizures upon discontinuation, supraventricular arrhythmia, trismus, urticaria, dysphagia, dry skin, hypotension, onychomycosis, hypoglycemia, worsening depression, edema, gastric ulcer, discomfort in the head, burning sensation, intellectual disability, drug intoxication, hiccups, respiratory distress, akathisia, abnormal dreams, emotional fluctuations, suicide attempt, overdose, increased appetite

Store this medication in a tightly closed container to prevent air or moisture ingress. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius.

Appearance

A hard capsule with a blue top and light yellow-green base containing white to light brown enteric-coated spherical granules.

Package unit

28 capsules (14 capsules/PTP x 2)