Duloxetine Hydrochloride Capsules 60mg

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial treatment This drug is administered at a dose of 60mg once daily, regardless of meals. In some patients, treatment may be started 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. 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 the need for continued treatment. 2) Treatment of generalized anxiety disorder Initial treatment This drug is administered at a dose of 60mg once daily, regardless of meals. In some patients, treatment may be started at 30mg once daily for 1 week to allow the patient to adjust to the medication, and then increased to 60mg once daily. Efficacy was 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, i.e., 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 the need for continued treatment. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, regardless of meals. Although 120mg once daily is safe and effective, 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 often occurs as a complication of diabetes, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment As the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. Although the efficacy of this drug when administered 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 started 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 of fibromyalgia treatment, 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 inadequately responsive 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. In patients who do not respond to the recommended dose (60mg/day), administering a dose exceeding 60mg per 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 required during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. 4. Patients with hepatic impairment As hepatic impairment may occur, this drug should not be used in patients with liver disease. 5. Patients with renal impairment No dose adjustment is required 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, whenever 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, reduce the dose by half or take the medication 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 starting treatment with this drug, at least 14 days should elapse between treatments. Conversely, when starting an MAO inhibitor to treat 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, 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 risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or 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

3. Children and adolescents under 18 years of age This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of safety and efficacy concerns. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is primarily used to treat symptoms associated with depression. There is an increased risk of suicidal thoughts or behavior when this drug is administered to children or adolescents, especially young adults between the ages of 18 and 24; thus, it should be used with caution. During treatment, a careful observation of changes in the patient's mental state should be performed, and family members or caregivers should also watch for any abnormal signs and consult a physician immediately if any are observed. This medication acts to regulate the level of serotonin, a neurotransmitter, and may lead to a serious side effect known as serotonin syndrome. Particularly, the risk is heightened when taken with other serotonergic medications, necessitating careful monitoring during concomitant administration. This medication should not be used in conjunction with certain medications, particularly MAO inhibitors, and should not be administrated to patients with impaired liver function or severe kidney disease, or those with uncontrolled glaucoma or hypertension. It is also contraindicated in patients with hypersensitivity or genetic disorders that impair the digestion of certain sugars. During treatment, blood pressure and heart rate should be monitored periodically, and in cases of elevated blood pressure, it may be necessary to consider dose adjustment or discontinuation of the medication. Orthostatic hypotension or symptoms of fainting may occur; thus, particularly during the initial treatment period and at dose increases, careful monitoring is warranted. This medication may increase the risk of bleeding in patients with a tendency for bleeding or those taking anticoagulants, so caution is needed. If severe allergic reactions such as rashes or symptoms like fever appear on the skin, administration should be stopped immediately. Elderly patients, dehydrated individuals, or those taking diuretics are at risk for developing hyponatremia, so caution is advised. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; it's important to taper the dose gradually under a physician’s guidance. There may be dizziness or drowsiness when driving or operating machinery, thus caution is recommended. Women who are pregnant or nursing should consult their physician prior to taking this medication, as it may affect newborns, particularly during late pregnancy. This medication is not recommended for use in children and adolescents under 18 years of age as safety and effectiveness have not been established. In cases of overdose, symptoms such as coma, seizures, and serotonin syndrome may arise; immediate medical attention is needed. This medication should be kept out of reach of children and stored in its original container to maintain its quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, diabetic neuropathic pain, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, reduced libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, paresthesia, tics, akathisia, neuroexcitation, attention deficit disorders, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastritis, belching, gastric ulcer, dysphagia, halitosis, stomatitis, bloody stools, 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, myalgia, oral dysphagia, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculation disorders, delayed ejaculation, abnormal uterine 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 serum potassium, increased serum cholesterol, muscle weakness, sensory reduction, concentration disorders, dyskinesia, dysarthria, abnormal dreams, loss of sense of direction, confusion, irritability, severe emotional fluctuations, suicide attempts, urination disorders, urinary urgency, nocturnal enuresis, polydipsia, abnormal urine odor, hypoactive sexual desire disorder, unusual sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, erythema multiforme, overflow incontinence, cutaneous vasculitis, microscopic colitis, seizures upon withdrawal, supraventricular arrhythmia, jaw opening dysfunction, hives, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, worsening depression, edema, gastric ulcer, discomfort in the head, burning sensation, intellectual disability, intoxication from medication, hiccups, respiratory distress

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius.

Appearance

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

Package unit

28 capsules/PTP