Duloxetine Capsule 30mg (Duloxetine Hydrochloride)

Adult dosage

Adults 1) 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, then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses exceeding 60mg once daily, and the dose-response relationship for the efficacy of this drug 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, 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, 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, then increased to 60mg once daily. Although efficacy was demonstrated at 120mg once daily, there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose of more than 60mg once daily is selected, 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 drug for generalized anxiety disorder, i.e., for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who elect to extend treatment 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, with or without food. Although it is safe and effective at 120mg once daily, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability was reduced 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 may be considered. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be evaluated individually. Although efficacy with treatment 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 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 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 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/day provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this drug for more than 13 weeks in 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 once daily are limited. 4. Patients with hepatic impairment This drug should not be used in patients with liver disease because 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 drug should not be administered to patients with end-stage renal disease (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, if possible, rather than abrupt discontinuation. To reduce the risk of withdrawal symptoms, after more than 1 week of drug treatment, it is recommended that the dose be gradually reduced beginning 2 weeks before discontinuation. During this period, reduce the dose by half or take it every other day. However, the exact approach should be determined based on the individual patient's circumstances, such as 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, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 days should have elapsed 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 treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to patients 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a nonintravenous route (oral tablets or local injection) or with intravenous administration of this drug at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Children's dosage

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 indications other than major depressive disorder have not been studied.

This medication is primarily used to treat symptoms associated with depression, particularly effective in major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain. This drug is not recommended for use in children and adolescents as safety and efficacy have not been established. During the initial period of taking this medication or when changing the dosage, there may be an increased risk of suicidal thoughts or behaviors, so patients and caregivers should closely monitor for such symptoms. Serotonin syndrome can occur as a serious side effect, so caution is especially needed when taking this medication with serotonin agents, and if symptoms appear, medical personnel should be notified immediately. Patients with poor liver function or severe renal disease should not take this medication, and patients with hypertension or uncontrolled glaucoma should also avoid this medication. This medication can increase blood pressure and heart rate, so patients with hypertension should regularly check their blood pressure, and they should be aware of the possibility of orthostatic hypotension or fainting symptoms. Patients with a tendency to bleed or who are taking anticoagulants or medications affecting platelet function should use this medication cautiously as it may increase the risk of bleeding. If severe skin reactions such as rashes, blisters, or mucosal damage occur during treatment, the patient should stop taking the medication immediately and consult healthcare personnel. During treatment, hyponatremia, which is a decrease in sodium concentration in the blood, may occur, so elderly patients and those with dehydration should be careful for symptoms and may need testing. This medication can affect urinary function, making it difficult to pass urine, so if there are issues with urination or difficulty in passing urine, medical personnel should be informed. Taking this medication may lead to uncomfortable symptoms such as psychomotor agitation; if these symptoms occur, dosage adjustments or discontinuation should be considered. Liver damage or hepatitis symptoms have been reported, so monitoring for signs of liver dysfunction is crucial. If the medication is abruptly stopped, withdrawal symptoms such as dizziness, sensory abnormalities, and sleep disturbances may occur, so it is safest to taper off under medical supervision when discontinuing. Drowsiness or dizziness may occur while taking this medication, so caution is required when driving or operating hazardous machinery. This medication can interact with other drugs; special caution is needed when combining with MAO inhibitors, serotonin agents, anticoagulants, CYP1A2 inhibitors, etc., and consultation with healthcare personnel is mandatory. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and it is not recommended during breastfeeding. Certain patient groups such as children, adolescents, elderly individuals, patients with liver disease, or renal disease should take special care when using this medication. In case of overdose, symptoms like coma, seizures, and serotonin syndrome may appear, and immediate emergency treatment is required. This medication should be stored out of reach of children and kept in its original container to maintain quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, suicidal ideation, teeth grinding, disorientation, sleep disorders, flat affect, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, myoclonus, restless legs syndrome, restlessness, irritability, attention deficit, taste disturbances, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, akathisia, extrapyramidal symptoms, blurred vision, pupillary dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, ventricular tachycardia, hypertension, flushing, hypertension, orthostatic hypotension, syncope, hypertensive crisis, 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, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myalgia, dysphagia, dysuria, frequent urination, nocturia, urinary 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, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, constipation, insomnia, sedation, weakness, decreased appetite, palpitations, vomiting, blurred vision, decreased appetite, dizziness, drowsiness, increased sweating, diarrhea, fatigue, headache, tremors, sensory disturbances, migraine, taste disturbances, insomnia, anxiety, sleep disorders, abnormal dreams, orgasmic dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, rash, itching, facial flushing, seasonal allergies, upper respiratory infection, urinary tract infection, influenza, gastroenteritis virus, weight gain, musculoskeletal pain, muscle spasm, headache, dizziness, drowsiness, tremors, sensory disturbances, migraine, taste disturbances, insomnia, anxiety, sleep disorders, abnormal dreams, orgasmic dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, rash, itching, facial flushing, palpitations, dizziness, ear pain, tinnitus, hypothyroidism, blurred vision, diplopia, vision loss, bloating, belching, gastritis, halitosis, stomatitis, gastric ulcer, hematochezia, melena, chills, tremors, abnormal sensations, warmth, coldness, physical discomfort, thirst, gait disturbances, gastroenteritis, laryngitis, weight gain, elevated serum cholesterol levels, dehydration, hyperlipidemia, dyslipidemia, musculoskeletal pain, muscle spasms, muscle cramps, taste disorders, weakness, sensory disturbances, sensory loss, attention deficit, abnormal movements, myoclonus, impaired sleep quality, speech disorders, abnormal dreams, sleep disorders, flat affect, teeth grinding, loss of spatial orientation, confusion, irritability, severe mood swings, suicide attempt, suicide, urination disorders, urgent urination, enuresis, polyuria, abnormal urine odor, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal symptoms, drooling, skin vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, muscle cramps, restless legs syndrome, seizures upon discontinuation, supraventricular arrhythmia, opening disorder, urticaria, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, worsening depression, edema, gastric ulcer, head discomfort, burning sensation, intellectual disability, depression, elevated serum bilirubin, drug intoxication, hiccups, respiratory distress, restlessness, abnormal dreams, emotional lability, overdose, weight loss, discontinuation of treatment due to adverse drug reactions, withdrawal symptoms, coma, seizures

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is best to keep the storage temperature between 15 to 30 degrees Celsius.

Appearance

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

Package unit

28 capsules/PTP