Droxetine Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial dosing This medicine 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 medicine has not been clearly established. Maintenance dosing 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 reevaluate the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial dosing This medicine 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 exceeding 60mg once daily is selected, it should be increased in increments of 30mg once daily. The safety of doses exceeding 120mg once daily has not been adequately evaluated. Maintenance dosing Generalized anxiety disorder is generally considered a chronic condition. The efficacy of long-term use of this medicine for generalized anxiety disorder, that is, for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who elect to extend treatment with this medicine should periodically reevaluate the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial dosing This medicine 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 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 dosing Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this medicine should be evaluated individually. Although the efficacy of treatment with this medicine 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 dosing The recommended dose of this medicine 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 with doses exceeding 60mg/day, and use of higher doses is associated with a higher incidence of adverse reactions. Maintenance dosing Fibromyalgia is considered a chronic condition. In placebo-controlled trials of fibromyalgia treatment, the efficacy of this medicine 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 dosing The recommended dose of this medicine 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), administering doses exceeding 60mg per day provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance dosing The safety and efficacy of this medicine 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 medicines, caution is required during treatment, and clinical data are limited, particularly for use at a dose of 120mg per day. 4. Patients with hepatic impairment Because hepatic impairment may occur, this medicine 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 medicine 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 medicine, gradual dose reduction over at least 1~2 weeks is recommended, if possible, rather than abrupt discontinuation. If treatment is discontinued 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, the dose may be reduced by half or administered 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 days must elapse after discontinuing this medicine before starting 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 must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring 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 medicine. If there is no alternative to linezolid or intravenous methylene blue and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient 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 medicine 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 tablets or local injection), or intravenous administration of this medicine 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

Children and adolescents under 18 years of age Because of concerns regarding safety and efficacy, this medication should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medication for indications other than major depressive disorder have not been studied.

This drug is primarily used to treat depression, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, osteoarthritis pain, etc. During the course of this medication, particularly in young individuals aged 18 to 24, there may be an increased risk of suicidal thoughts or behaviors, so physicians and caregivers should closely monitor the patient's condition. There is a risk of serious side effects called serotonin syndrome, which may include changes in mental status, high fever, tremors, convulsions, and vomiting, and the risk increases when this drug is taken with certain other medications. This medication should not be taken with certain drugs, especially MAO inhibitors, and should not be administered to patients with severely impaired liver or kidney function, uncontrolled high blood pressure, certain glaucoma patients, and patients with certain metabolic disorders. Patients with mania or bipolar disorder, epilepsy, bleeding tendencies, the elderly, and dehydrated patients should use this drug with caution. Common side effects may occur initially, such as nausea, headache, dry mouth, drowsiness, and dizziness, and most of these improve over time. Abruptly stopping this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors, so the dosage should be gradually decreased according to the physician's instructions. Increased blood pressure and heart rate may occur, thus patients with hypertension or heart disease should regularly check their blood pressure. The risk of bleeding may increase, so patients taking anticoagulants or medications affecting platelet function should exercise caution. Serious side effects related to liver damage have been reported, so if liver dysfunction is suspected, immediate consultation with a doctor is required. Pregnant or breastfeeding women should consult their doctor before taking this medication, especially in late pregnancy as there may be side effects in newborns. Caution should be taken when driving or operating dangerous machinery due to the risk of accidents from drowsiness or dizziness. In case of overdose, symptoms such as coma, seizures, or serotonin syndrome may occur, and immediate medical attention should be sought. This medication is not recommended for children and adolescents as safety and efficacy have not been established. During treatment, always inform the doctor about other medications being taken and health conditions, and ensure regular check-ups, reporting any abnormal symptoms immediately.

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 thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremors, paresthesia, myoclonus, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, pupil dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac arrhythmia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, interstitial lung disease, eosinophilic pneumonia, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastritis, belching, gastric ulcer, dysphagia, halitosis, stomatitis, bloody stools, microscopic colitis, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, cutaneous vasculitis, musculoskeletal pain, muscle cramps, muscle tension, myopathy, opening mouth disorder, dysuria, frequent urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urinary flow, unusual urine odor, erectile dysfunction, ejaculation problems, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, asthenia, sensory disorders, sleep disorders, myalgia, hypersensitivity, hyperhidrosis, migraine, taste disturbance, nightmares, sexual indifference, decreased libido, ejaculation dysfunction, cough, sore throat, pruritus, facial flushing, decreased blood pressure, onychomycosis, decreased vision, yawning, worsening depression, mood swings, suicide attempts, overdose, urticaria, acute pancreatitis, anaphylaxis, erythema multiforme, extrapyramidal disorder, enuresis, edema, gastric ulcer, uncomfortable head sensation, burning sensation, mental retardation, drug intoxication, hiccups, dyspnea, trismus

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 15 to 30 degrees Celsius.

Appearance

A hard capsule with blue upper part and white lower part containing white to pale yellow enteric-coated pellets.

Package unit

30 capsules/bottle, 200 capsules/bottle