Duloxetine 30 mg Capsules (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 them to adjust to the medication, 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 improve, 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, with or without food. In some patients, treatment may be initiated at 30mg once daily for 1 week to allow them to adjust to the medication, 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, it 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, beyond 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, 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, initiating treatment at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider initiating treatment 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. 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. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses exceeding 60mg/day, 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 treatment for 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 to 60mg once daily. Administration of doses exceeding 60mg per day to patients who do not respond to the recommended dose (60mg/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 needed during treatment, particularly because clinical data on the use of a 120mg daily dose 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 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 (those 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. If discontinuing treatment after more than 1 week of medication use, gradual dose reduction beginning 2 weeks beforehand is recommended 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, 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 initiating treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when initiating 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 who require treatment for 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, 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 comes first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks 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 are 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: Because of concerns regarding safety and efficacy, this medicine should not be used to treat major depressive disorder in children and adolescents under 18 years. The safety and efficacy of this medicine for indications other than major depressive disorder have not been studied.

This medication should be used with caution in children, adolescents, and younger adults with major depressive disorder or psychiatric disorders due to an increased risk of suicidal impulses and behavior. During the course of this medication, careful observation for any changes in mental state, suicidal thoughts, aggression, anger, or abnormal behavior should be conducted, and family members or caregivers should also closely monitor the patient. There is a risk of serious side effects known as serotonin syndrome, which increases with the concomitant use of other serotonergic agents; therefore, caution must be exercised regarding co-administration. This medication must not be used in combination with certain drugs, especially MAO inhibitors, due to the potential for serious side effects. Patients with liver or kidney impairment, uncontrolled hypertension, glaucoma, or certain sugar absorption disorders should not use this medication. Patients with a history of mania, bipolar disorder, epilepsy, hypertension, heart disease, or bleeding tendencies should exercise special caution when using this medication. Common initial symptoms may include nausea, headache, dry mouth, drowsiness, and dizziness, most of which improve over time. If this medication is suddenly stopped, withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, and nausea may occur, so it should be tapered gradually under a doctor’s direction. Blood pressure increases or heart rate increases may occur, so patients with hypertension should regularly check their blood pressure, and orthostatic hypotension or fainting may occur. There may be an increased risk of bleeding, so patients taking anticoagulants or medications affecting platelet function should be cautious. Severe skin reactions may occur, and if symptoms such as rash, blisters, or mucosal injuries occur, discontinue use immediately and consult a physician. Abnormal liver function has been reported; therefore, patients with liver diseases should undergo regular liver function tests. This medication may cause drowsiness or dizziness while driving or operating machinery, so caution is necessary. There are many drug interactions; be particularly cautious when co-administering with alcohol, sedatives, MAO inhibitors, or serotonergic agents. During pregnancy, the safety of the fetus has not been established, and use should be limited to necessary cases. During breastfeeding, it is advisable to avoid nursing. It is recommended that this medication not be used in children and adolescents under 18 years of age due to the lack of established safety and efficacy. In cases of overdose, serious symptoms such as coma, seizures, or increased heart rate may occur, requiring immediate emergency treatment. Store this medication out of the reach of children and ensure it is kept in its original container to maintain quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, laryngitis, anaphylactic reaction, 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 disorder, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremor, sensory disturbances, myoclonus, akathisia, neurodermatitis, attention deficit disorder, taste disturbances, 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, palpitations, tachycardia, arrhythmia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastritis, belching, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, hives, contact dermatitis, photosensitivity reaction, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, jaw opening disorder, dysuria, frequency of urination, nocturia, hesitancy in urination, 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 hemorrhage, fatigue, falls, chest pain, hot/cold sensation, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased blood creatine phosphokinase, increased blood potassium, increased blood cholesterol, acute pancreatitis, erythema multiforme, cutaneous vasculitis, diuresis, microscopic colitis, seizures upon treatment discontinuation, supraventricular arrhythmia, trismus, decreased blood pressure, onychomycosis, worsening depression, edema, discomfort in the head, burning sensation, mental retardation, intoxication from medication, hiccups, dyspnea, akathisia, abnormal dreams, emotional lability, suicide attempt, overdose

This medication should be stored in a tightly sealed container to avoid exposure to air or humidity. Additionally, it is best stored at room temperature between 15 and 30 degrees Celsius.

Appearance

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

Package unit

28 capsules (14 capsules/PTP packaging x 2)