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 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, response to antidepressant treatment 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 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 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. 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 decreased 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, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because diabetic peripheral neuropathic pain varies in its progression and pain control is empirical, the effect of this drug should be assessed 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 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 considered 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. For 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 necessary 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 (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, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take it 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 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, 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently 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 stopped 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 a non-intravenous route (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 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 used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain. Particularly in children, adolescents, and young adults, it may increase the risk of suicidal thoughts or behaviors, thus physicians should carefully evaluate the necessity and risks of treatment. Patients should be closely monitored during treatment for worsening of their condition or emergence of abnormal behavioral changes like suicidal thoughts, aggression, or anger, with family or caretakers also paying attention. Severe adverse reactions known as serotonin syndrome may occur, so this drug should not be used in conjunction with serotonergic agents or MAO inhibitors, and symptoms of serotonin syndrome should be watched closely if concurrent use is necessary. This drug should not be administered to those with hypersensitivity to the ingredients or patients with liver disease, end-stage kidney disease, uncontrolled angle-closure glaucoma, or uncontrolled hypertension. It should also be used with caution in patients with certain genetic disorders or those at high risk for drug interactions. Common side effects include nausea, headache, dry mouth, drowsiness, and dizziness, which primarily occur at the beginning of treatment and tend to alleviate over time. Abrupt discontinuation of this drug can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and tremors, so it is recommended to taper off the dosage gradually. Serious side effects such as increased blood pressure, orthostatic hypotension, increased risk of bleeding, severe skin reactions, hyponatremia, urinary retention, and psychomotor agitation may occur, hence caution is advised. The drug poses potential risks to the fetus during pregnancy and should only be used when necessary. It is not recommended during breastfeeding due to the possibility of drug exposure through breast milk. The safety and efficacy of this drug have not been established for children under 18 years of age. Dosage adjustments are not recommended for the elderly, but caution is advised during treatment. In cases of overdose, symptoms may include coma, tachycardia, serotonin syndrome, seizures, and immediate medical attention should be sought. Caution is needed when driving or operating machinery as drowsiness or dizziness may occur. This drug may interact with various medications, so it is essential to inform your doctor or pharmacist if you are taking other drugs. Finally, this drug should be stored out of reach of children and kept in its original container to prevent misuse or deterioration in quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, laryngitis, anaphylaxis, hypersensitivity disorder, hypothyroidism, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, somnolence, tremors, paresthesia, tonic-clonic syndrome, restless legs syndrome, nervousness, attention deficit disorder, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, heart palpitations, tachycardia, complex ventricular arrhythmia, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stools, elevated liver enzyme levels, 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, jaw clenching disorder, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum bleeding, fatigue, falls, chest pain, hot/cold sensation, lethargy, thirst, abnormal sensation, chills, gait disorders, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, upper respiratory infection, urinary tract infection, influenza, gastroenteritis virus, seasonal allergies, musculoskeletal pain, migraine, dysgeusia, insomnia, restlessness, sleep disorder, abnormal dreams, orgasm dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, itching, facial flushing, weight gain, paresthesia, concentration difficulties, dyskinesia, speech disorder, abnormal dreams, sleep disorders, apathy, bruxism, spatial disorientation, confusion, irritability, severe mood swings, suicide attempts, suicide, voiding dysfunction, urgent urination, nocturnal enuresis, polyuria, abnormal urine odor, sexual aversion disorder, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, erythema multiforme, cutaneous vasculitis, edema, worsening of depression, mood swings, overdose, hiccups, dyspnea, restlessness, abnormal dreams, worsening of depression, mood swings, suicide attempts, overdose

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

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

Package unit

28 capsules (14 capsules/PTP x 2)