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, the therapeutic response to antidepressants begins to appear after 2~4 weeks. After depressive symptoms improve, continued use of the medication 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 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 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. Although doses of 120mg once daily are safe and effective, 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 is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment The effect of this drug should be assessed individually because diabetic peripheral neuropathic pain varies in its progression and pain control is empirical. Although efficacy with administration of 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. No evidence of additional benefit has been observed at doses exceeding 60mg/day, even in patients who do not respond to 60mg, and higher doses are 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 to continue 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 and 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 for more than 13 weeks in 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, as hepatic impairment may occur. 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, if possible, rather than abrupt discontinuation. When discontinuing treatment after more than 1 week of medication use, gradually reduce the dose beginning 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 method should be determined based on the individual patient's circumstances, such as the duration of treatment and the dose being taken at the time of discontinuation. 7. Switching from or to MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, 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 who require treatment of a more urgent psychiatric condition, including hospitalization or 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, 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 nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses 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 must not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns regarding its safety and efficacy. The safety and efficacy of this medicine for indications other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; therefore, when prescribing to patients in these age groups, the physician must carefully evaluate the need. During the use of this medication, patients should be closely monitored for any worsening of depressive symptoms, suicidal thoughts, aggression, anger, or other abnormal behavior changes, with family members or caregivers also encouraged to observe the patient and maintain communication with the physician. Serious side effects known as serotonin syndrome may occur; therefore, caution is especially needed when used in conjunction with serotonergic drugs, and symptoms of this syndrome include changes in mental state, unstable blood pressure, tremors, high fever, nausea, and vomiting. This medication is contraindicated for use with certain drugs, particularly MAO inhibitors, and should strictly follow the doctor’s directions. Some patients, such as those with liver disease, end-stage renal disease, uncontrolled glaucoma, or hypertension, may be prohibited from taking this medication or require cautious use. Common side effects such as nausea, headache, dry mouth, drowsiness, and dizziness may occur during initial use; most of these improve over time. Abrupt discontinuation of this medication may cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and headache; therefore, when discontinuing, it is advised to gradually taper the dose under a doctor’s guidance. Blood pressure elevation and increased heart rate may occur, so patients with hypertension or heart disease should regularly monitor their blood pressure. Orthostatic hypotension or fainting may occur, particularly during early usage, and attention is needed for patients with a tendency for bleeding or those on anticoagulants regarding bleeding risks. Severe skin reactions or symptoms of liver damage may occur, so if skin rashes or jaundice symptoms are seen, medication should be stopped immediately, and the patient should consult a doctor. During pregnancy, potential risks to the fetus are present; therefore, if pregnancy is planned or the patient is pregnant, consultation with a physician is essential, and use during breastfeeding is not recommended. Elderly patients may also take this medication; however, caution is especially needed at high doses. In case of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, requiring immediate emergency treatment. This medication has not been established for safety and efficacy in children and adolescents.

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 ideation, bruxism, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremors, sensory disturbances, tardive dyskinesia, restlessness, irritability, attention deficit disorder, gustatory 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, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, 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, phototoxic reaction, clammy sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, difficulty opening the mouth, dysuria, increased frequency of urination, nocturia, hesitant urination, 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 feelings, lethargy, thirst, abnormal sensations, chills, gait disorders, weight loss, weight gain, elevated serum creatine phosphokinase, elevated serum potassium, elevated serum cholesterol, constipation, insomnia, sedation, asthenia, decreased appetite, palpitations, headache, dizziness, drowsiness, tremors, sensory disturbances, migraine, taste disturbances, insomnia, anxiety, sleep disorders, abnormal dreams, orgasm problems, decreased libido, ejaculation issues, penile disorders, cough, sore throat, hyperhidrosis, rash, itching, facial flushing, vascular disorders, facial flushing, flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, erythema multiforme, cutaneous vasculitis, edema, worsened depression, mood swings, suicide attempts, overdose, restlessness, drug intoxication, hiccups, respiratory distress, erectile dysfunction, delayed ejaculation, sexual dysfunction, decreased blood pressure, onychomycosis, skin dryness, dysphagia, fever, stupor, chest discomfort, elevated serum bilirubin, intellectual disability, weight gain, akathisia, speech disturbances, loss of orientation, confusion, severe mood swings, suicide, urinary disorders, urgency in urination, enuresis, polyuria, abnormal urine odor, sexual indifference, abnormal sexual arousal, menopausal syndrome, yawning, throat tightness, elevated blood pressure, decreased blood pressure, elevated serum cholesterol, dehydration, hyperlipidemia, dyslipidemia, muscle cramping, concentration difficulties, decreased sleep quality, palpitations, abdominal pain, worsened depression, diarrhea, weight loss, seizures, coma, stupor, tachycardia, drowsiness, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma, nausea, vomiting, seizures, stupor, coma

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and storage temperature should be maintained between 15 to 30 degrees Celsius. This helps to maintain the medication's effectiveness.

Appearance

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

Package unit

28 capsules/PTP