Duloxetine Hydrochloride Capsule 60 mg (Duloxetine)

Adult dosage

Adults 1) Treatment of major depressive disorder Initial treatment This medication 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 medication 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 recurrence. The physician should periodically reassess the patient to determine the need for continued treatment. 2) Treatment of generalized anxiety disorder Initial treatment This medication 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 greater than 60mg once daily is chosen, 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 medication for generalized anxiety disorder, that is, use for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend use of this medication should periodically reassess the patient to determine the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medication 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 the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this medication should be assessed individually. Although efficacy with administration 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 medication 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 was observed at doses exceeding 60mg/day, even in patients who did 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 medication was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term studies 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 medication 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 administration of this medication 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 required 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 medication 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 medication 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 medication, 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 reduction of the dose beginning 2 weeks beforehand is recommended to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take the medication every other day. However, the specific 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 or to MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse between discontinuation of an MAO inhibitor used to treat psychiatric disorders and initiation of treatment with this medication. Conversely, at least 5 days should elapse after discontinuation of this medication before initiating an MAO inhibitor for the treatment of psychiatric disorders. 8. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not be started on this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventional procedures should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue preparations to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue preparations is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue preparations are judged to outweigh the risk of serotonin syndrome, this medication may be discontinued immediately and linezolid or intravenous methylene blue preparations administered. Patients should be monitored for symptoms of serotonin syndrome for 5 days after administration of linezolid or intravenous methylene blue preparations, or until 24 hours after the last dose, whichever comes first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue preparations. The risk associated with administration of methylene blue preparations by non-intravenous routes (oral tablets or local injection), or intravenous administration of this medication 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 Because of concerns about safety and efficacy, this medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is used in the treatment of major depressive disorder and other psychiatric conditions; it is not approved for use in children or adolescents under 18 years old. During treatment with this medication, there may be an increased risk of suicidal thoughts or behavior, thus young adult patients aged 18 to 24 should be closely monitored. There is a risk of a serious side effect known as serotonin syndrome, so it is essential to consult a physician before combining this medication with any serotonin-acting drugs. This medication should not be taken together with MAO inhibitors, as it may cause life-threatening side effects. Patients with liver dysfunction, end-stage renal disease, uncontrolled hypertension, or angle-closure glaucoma should not take this medication. Common side effects include nausea, headache, dry mouth, drowsiness, and dizziness, which mostly occur at the beginning of treatment and tend to improve with time. Abruptly stopping this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, and nausea; therefore, the dose should be gradually reduced. Patients with hypertension or heart diseases should monitor their blood pressure periodically, as there may be increases in blood pressure and heart rate. Orthostatic hypotension and fainting may occur, so caution is needed at the start of treatment or when increasing the dosage. Patients with bleeding tendencies or those taking anticoagulants or antiplatelet agents should be cautious, as there is an increased risk of bleeding. Severe skin reactions may occur; if symptoms such as rash, blisters, or mucosal damage appear, immediately discontinue use and consult a physician. Elderly patients may have an increased risk of hyponatremia, so their hydration status and diuretic use should be assessed carefully. Drowsiness or dizziness may occur when driving or operating hazardous machinery, so caution is advisable. The central nervous system depressant effects of this medication may be enhanced when taken with alcohol or sedatives, so caution is advised. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and it is advisable to avoid use while breastfeeding. In cases of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur, necessitating immediate emergency treatment. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation in quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, laryngitis, anaphylactic reaction, hypersensitivity disorder, hypothyroidism, appetite reduction, 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, aggression and anger, lethargy, tremors, sensory abnormalities, dystonia, 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, ventricular tachycardia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crises, yawning, throat 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 spasms, oral dystonia, dysuria, frequent urination, nocturia, hesitancy, 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 sensations, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased potassium levels in blood, increased blood cholesterol, acute pancreatitis, erythema multiforme, hyperhidrosis, skin vasculitis, microscopic colitis, supraventricular arrhythmia, trismus, urticaria, decreased blood pressure, onychomycosis, worsening depression, edema, gastric ulcer, headache, burning sensation, mental retardation, drug intoxication, overdose, hiccups, dyspnea, restlessness, abnormal dreams, emotional lability, suicide attempt, overdose

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store it at a temperature between 15°C and 30°C to maintain its effectiveness.

Appearance

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

Package unit

28 capsules/PTP