Duloprex Capsule 30 mg (Duloxetine Hydrochloride)

Adult dosage

1. 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 them 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, a response to antidepressant treatment begins to appear after 2~4 weeks. Continued medication use for several months is recommended to prevent recurrence even after depressive symptoms have improved. 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 them 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 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, that is, for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to continue 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, with or without food. 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 tolerability concerns, initiation at a lower dose may be considered. For patients with renal impairment, which often occurs as a complication of diabetes, initiation at a lower dose followed by gradual dose increases should be considered. Maintenance treatment Because the progression 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 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 with 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 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 studies 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), 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. 2. Elderly patients Dose adjustment based on age is not recommended. However, as with other medications, caution should be exercised during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. 4. Patients with hepatic impairment This drug should not be used in patients with liver disease, as hepatic impairment may occur. 5. Patients with renal impairment Dose adjustment is not 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). 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, gradual dose reduction beginning 2 weeks before discontinuation is recommended to reduce the risk of withdrawal symptoms. During this period, the dose may be halved or the medication taken every other day. However, the precise approach should be determined in consideration of each 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 drug, an interval of at least 14 days should be allowed. Conversely, when initiating an MAO inhibitor for the treatment of 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 be started on this drug because of the increased risk of serotonin syndrome. For patients who require 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 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 occurs 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 with 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

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 concerns regarding safety and efficacy. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is used to treat psychiatric disorders such as major depressive disorder, and careful observation is needed due to an increased risk of suicidal thoughts or behaviors, particularly in young individuals aged 18 to 24. Additionally, this medication can cause a serious adverse reaction known as serotonin syndrome, which is more likely to occur when taken with other serotonergic drugs. It should not be taken with certain medications, particularly MAO inhibitors, and it is not safe for patients with severely impaired liver or kidney function, uncontrolled hypertension, or angle-closure glaucoma. Blood pressure and heart rate should be monitored periodically while on this medication, as postural hypotension or fainting symptoms may occur. Patients with a tendency to bleed or those taking anticoagulants or drugs affecting platelet function should be cautious as the risk of bleeding may increase. This medication can cause severe allergic reactions or severe skin disorders; therefore, if symptoms such as rash, blisters, or mucosal injury occur, administration should be stopped immediately. Elderly patients, dehydrated patients, or those on diuretics should be closely monitored for the risk of hyponatremia. Abrupt cessation of this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders, so the dosage should be gradually reduced as directed by a physician. Caution should be exercised when driving or operating machinery, as drowsiness or dizziness may occur. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and lactating women are advised against its use as it may be transmitted through breast milk. Safety and efficacy have not been established for children and adolescents under 18 years of age, so use in this population is not recommended. In case of overdose, there is a risk of coma, seizures, and serotonin syndrome; therefore, care must be taken not to exceed the prescribed dosage, and immediate medical assistance should be sought if an overdose is suspected. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration.

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 ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, myoclonus, restlessness, neuroexcitation, attention disorders, taste disturbances, 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, 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 reaction, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myospasm, jaw clenching disorder, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine output, unusual urine odor, erectile dysfunction, ejaculation disorders, 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 creatinine phosphokinase, hyperkalemia, increased serum cholesterol, insomnia, sedation, weakness, poor appetite, palpitations, headache, dizziness, drowsiness, tremors, migraine, taste disturbances, insomnia, restlessness, sleep disorders, abnormal dreams, decreased libido, ejaculation disorders, penile disorders, cough, sore throat, sweating, rash, itching, facial flushing, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal syndrome, enuresis, glaucoma, skin vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reaction, hypertensive crisis, microscopic colitis, muscle cramps, rash, restless legs syndrome, seizures upon withdrawal, supraventricular arrhythmia, tinnitus, jaw clenching disorder, urticaria, dizziness, xerostomia, constipation, diarrhea, dyspepsia, fatigue, decreased appetite, vomiting, blurred vision, sedation, weakness, drowsiness, headache, tremors, sensory disturbances, migraine, taste disturbances, insomnia, restlessness, sleep disorders, abnormal dreams, decreased libido, ejaculation disorders, penile disorders, cough, sore throat, sweating, rash, itching, facial flushing, weight gain, dehydration, hyperlipidemia, dyslipidemia, musculoskeletal pain, muscle contraction, muscle cramps, taste disorders, malaise, sensory disturbances, concentration disorders, dyskinesia, myoclonus, decreased sleep quality, speech disorder, abnormal dreams, sleep disorders, apathy, bruxism, loss of directional sense, confusion, hypersensitivity, severe mood swings, suicide attempt, suicide, urinary disorders, urgency in urination, nocturnal enuresis, polyuria, abnormal urine odor, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightening, facial flushing, flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, aggression and anger, angioedema, erythema multiforme, extrapyramidal symptoms, enuresis, glaucoma, skin vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reaction, hypertensive crisis, microscopic colitis, muscle cramps, rash, restless legs syndrome, seizures upon withdrawal, supraventricular arrhythmia, tinnitus, jaw clenching disorder, urticaria

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best kept in a cool place between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance

Enteric-coated spherical granules that are white to light brown contained in hard capsules with a blue upper part and a white lower part.

Package unit

28 capsules/PTP