Duloxetine Capsule 60mg (Duloxetine Hydrochloride)

Adult dosage

Adults 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. 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. 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 exceeding 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 known to be 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 the need for continued treatment. 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. In patients for whom tolerability is a concern, 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 Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be assessed individually. The efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, a 1-year open-label safety study was conducted. 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 administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is known to be 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. 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. In patients who do not respond to the recommended dose (60mg/day), administration of doses 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. 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. Patients with hepatic impairment Because hepatic impairment may occur, this drug should not be used in patients with liver disease. 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). Discontinuation of treatment When discontinuing this drug, gradual dose reduction over at least 1~2 weeks is recommended whenever possible, rather than abrupt discontinuation. To reduce the risk of withdrawal symptoms when discontinuing treatment after more than 1 week of medication use, it is recommended that the dose be gradually reduced beginning 2 weeks beforehand. During this period, the dose may be reduced by half or taken 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. 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, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days must have elapsed after discontinuing this drug. 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 for a more urgent psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available 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 drug 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 drug may be resumed 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 a dose 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 drug should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns regarding safety and efficacy. The safety and efficacy of this drug for indications other than major depressive disorder have not been studied.

This drug may increase the risk of suicidal thoughts and behaviors in young patients with major depressive disorder or psychiatric conditions, so physicians should carefully evaluate the risks and benefits prior to administration. It is not approved for use in children and adolescents, and suicide tendencies should be carefully monitored in this age group. Severe side effects such as serotonin syndrome may occur, so caution should be exercised when combined with serotonergic medications, and the medication should be discontinued immediately if symptoms appear. Concomitant use with specific MAO inhibitors is contraindicated, and it should not be administered to patients with liver disease, end-stage kidney disease, uncontrolled glaucoma, or hypertension. Patients with mania or bipolar disorder, kidney impairment, hypertension, or bleeding tendencies should be given the medication with caution. Side effects such as nausea, headache, dry mouth, drowsiness, and dizziness are common during treatment, mostly occurring early and improving over time. Abrupt discontinuation of this drug may result in withdrawal symptoms like dizziness, sensory disturbances, and sleep disturbances, so the dosage should be gradually reduced. Blood pressure increases and heart rate elevation may occur, so hypertensive patients should regularly monitor their blood pressure, and care should be given to symptoms of orthostatic hypotension and fainting. The risk of bleeding may increase, so caution is necessary for patients taking anticoagulants or drugs affecting platelet function. Severe skin reactions may rarely occur, so if rashes, blisters, or mucosal damage appear, treatment should be discontinued immediately. There is a risk of liver damage, so if symptoms of liver dysfunction occur, consultation with a physician is advised, and caution should be exercised during pregnancy due to potential risks to the fetus. Women who are breastfeeding should avoid nursing as small amounts of the medication may be secreted into breast milk. There is a risk of accidents due to drowsiness or dizziness while driving or operating machinery, so caution is advised. There may be interactions with other medications, so it is essential to inform the physician or pharmacist about any concurrent medications. In cases of overdose, severe symptoms such as coma, seizures, or serotonin syndrome may occur, so immediate medical attention is necessary. This medication should be kept out of the reach of children and stored in its original container to prevent degradation.

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, agitation, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, paresthesia, torsion dystonia, restlessness, neuroexcitability, attention deficit, dysgeusia, 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, elevated blood pressure, flushing, hypertension, peripheral chilliness, orthostatic hypotension, syncope, hypertension crisis, yawning, throat stiffness, nosebleeds, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver damage, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, phototoxic reactions, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle spasms, muscle tension, muscle stiffness, oral opening dysfunction, dysuria, polyuria, nocturia, urinary hesitancy, urinary retention, diuresis, decreased urine flow, unusual 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, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, elevated serum potassium, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, incontinence, cutaneous vasculitis, edema, decreased blood pressure, onychomycosis, confusion, chest discomfort, dry skin, elevated serum bilirubin, state of intoxication, overdose, hiccups, shortness of breath, opening disorder, self-harm, suicidal thoughts, suicidal behavior

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is important to maintain the storage temperature between 15 to 30 degrees Celsius. This will help to preserve the effectiveness of the medication.

Appearance

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

Package unit

28 capsules/ PTP (14 capsules/PTP*2)