Duloxetine Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

Adults - Treatment of major depressive disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow them to adjust to the medicine, 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 treatment In general, response to antidepressant treatment begins to appear after 2∼4 weeks. Even after depressive symptoms have improved, it is recommended that patients continue taking the medicine for several months to prevent recurrence. The physician should periodically reassess the patient to determine whether continued treatment is necessary. -Treatment of generalized anxiety disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow them to adjust to the medicine, 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 prescribed, 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 medicine for generalized anxiety disorder, i.e., for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to continue treatment with this medicine should periodically reassess the patient to determine whether continued treatment is necessary. -Treatment of diabetic peripheral neuropathic pain Initial treatment 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 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 diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this medicine should be assessed individually. The efficacy of this medicine when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials, but a 1-year open-label safety study has been conducted. -Treatment of fibromyalgia Initial treatment The recommended dose of this medicine is 60mg once daily. To allow patients to adjust to the medicine, 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. 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 known to be a chronic condition. In placebo-controlled trials of treatment for fibromyalgia, 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 individual patient's response. -Treatment of osteoarthritis pain with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial treatment The recommended dose of this medicine is 60mg once daily. To allow patients to adjust to the medicine, 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 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, particularly because clinical data on the use of a dose of 120mg per day are limited. 4) Patients with hepatic impairment This medicine should not be used in patients with liver disease, as hepatic impairment may occur. 5) Patients with renal impairment No dose adjustment is necessary in 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 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 the medicine may be 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. 7) 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 medicine, an interval of at least 14 days should be allowed. Conversely, at least 5 days must have elapsed after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. 8) Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a 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 who is already receiving this medicine. 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 medicine 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 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 non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine 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: The safety and efficacy of this drug have not been studied in children and adolescents under 18 years of age. Therefore, use is not recommended.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders. Patients of all ages starting treatment should be closely monitored for worsening symptoms, suicidal tendencies, aggressiveness, or other unusual behavioral changes. There may be serious side effects, such as serotonin syndrome, especially when used in combination with certain medications; if symptoms occur, treatment must be stopped immediately. This medication is contraindicated in patients with hypersensitivity to its ingredients or those taking MAO inhibitors, severely impaired liver or kidney function, or those with uncontrolled glaucoma or hypertension. Patients with a history of mania, bipolar disorder, seizures, or bleeding tendencies, as well as elderly patients, should be closely administered and blood pressure and heart condition should be regularly monitored. Common side effects during treatment may include nausea, headache, dry mouth, drowsiness, dizziness, etc., most of which usually start early in treatment and lessen over time. Sudden discontinuation can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, and anxiety, so dosage should be tapered gradually prior to stopping. During pregnancy, there may be potential risks to the fetus, so it should only be used when necessary, and caution is advised during breastfeeding as a small amount of the drug may be excreted in breast milk. The safety and efficacy of this drug in children under 18 years of age have not been established, so its use is not recommended. In case of overdose, serious symptoms such as coma, seizures, and serotonin syndrome can occur, necessitating immediate medical attention. Drowsiness or dizziness may occur when driving or operating heavy machinery, so caution is advised. Additionally, there may be interactions with other medications; be sure to inform your doctor or pharmacist of any other medications you are taking.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, 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, tremor, paresthesia, myoclonus, restless leg syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, dizziness, ear pain, palpitations, tachycardia, ventricular 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, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photophobia, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle stiffness, muscle spasm, mouth opening disorder, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, 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 sensations, malaise, thirst, abnormal sensations, chills, gait disorders, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, lichen planus, cutaneous vasculitis, microscopic colitis, supraventricular arrhythmia, trismus, urticaria, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, worsening depression, edema, restlessness, abnormal dreams, mood swings, suicide attempt, overdose, intoxicated state, hiccups, shortness of breath

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 15 to 30 degrees Celsius. This helps in maintaining the effectiveness of the medication over time.

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 X 2)