Duloxetine Capsule 60 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 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, 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 whether continued treatment is necessary. 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, 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 greater 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 extend treatment with this drug should periodically reassess the patient to determine whether continued treatment is necessary. 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, starting at a lower dose may be considered. In patients with renal impairment, which often occurs as a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment Because diabetic peripheral neuropathic pain has a variable course 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. 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. 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 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. Administration of doses exceeding 60mg per day to patients who do not respond to the recommended dose (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 when administered for more than 13 weeks for the treatment of osteoarthritis pain have not been studied. 2. Elderly 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 the 120mg daily dose are limited. 4. Patients with hepatic impairment Because hepatic impairment may occur, this drug should not be used in patients with liver disease. 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 whenever possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, it is recommended to gradually reduce the dose 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 specific 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 drug, at least 14 days must elapse. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days must 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 this drug because of the increased risk of serotonin syndrome. For patients who require treatment of a more urgent psychiatric condition, including hospitalization or other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 a non-intravenous route (oral tablets or local injection) or with 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 such use.

Children's dosage

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

This medication is used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults, so it should be administered with caution, especially in patients aged 18 to 24. During treatment, the patient's suicidal tendencies, aggression, anger, and other abnormal behavioral changes should be closely monitored, and family members or caregivers should carefully observe the patient as well. Additionally, this medication can cause a severe side effect known as serotonin syndrome, hence special caution is needed when combined with other serotonergic drugs. It should not be taken with MAO inhibitors, and a certain period must be observed before starting other medications after discontinuation. Patients with liver disease, end-stage kidney disease, uncontrolled angle-closure glaucoma, uncontrolled hypertension, and certain genetic disorders should not take this medication. Patients with mania or bipolar disorder, those with a history of seizures, kidney and heart diseases, bleeding tendencies, elderly patients, etc., should take this medication cautiously. Common side effects during treatment include nausea, headache, dry mouth, drowsiness, dizziness, etc., which mostly occur early in treatment and tend to diminish over time. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, sensory disorders, sleep disturbances, anxiety, nausea, headache, therefore the dosage should be reduced gradually under a doctor's supervision. This medication may increase blood pressure and the risk of hypertensive crises, so patients with hypertension should regularly check their blood pressure, and caution is warranted due to the risk of orthostatic hypotension and fainting. The risk of bleeding may be increased, so patients taking anticoagulants or medications affecting platelet function should be particularly careful. Severe skin reactions may occur, so if symptoms such as rash, blisters, or mucosal lesions appear, medication should be stopped immediately, and medical consultation should be sought. There have been reports of liver function abnormalities and damage symptoms such as hepatitis and jaundice, thus patients with a history of liver disease should undergo regular liver function tests. Drowsiness or dizziness might occur when driving or operating machinery, therefore caution is warranted, especially when combined with alcohol or sedatives, which are central nervous system depressants. The use of this medication during pregnancy is not clearly indicated for fetal effects, so it should only be used when clearly necessary. During breastfeeding, it is secreted in small amounts in breast milk, and breastfeeding is not recommended. This medication is not recommended for children and adolescents under 18, as its safety and efficacy have not been established. In case of overdose, severe symptoms such as coma, seizures, and serotonin syndrome may appear, and immediate emergency treatment is required. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration in quality.

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 thoughts, bruxism, disorientation, sleep disturbances, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, hypersomnia, tremors, sensory disturbances, akathisia, restlessness, irritability, attention deficit, dysgeusia, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, 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 tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, blood in stools, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, phototoxic reaction, diaphoresis, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, musculoskeletal spasm, jaw clenching disorder, 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, acute pancreatitis, anaphylaxis, erythema multiforme, cutaneous vasculitis, edema, gastric ulcer, blood in stools, black stools, chills, tremors, abnormal sensations, heat sensation, cold sensation, physical discomfort, gait disturbances, gastroenteritis, laryngitis, upper respiratory tract infection, urinary tract infection, influenza, gastroenteritis virus, weight gain, hyperlipidemia, dyslipidemia, taste disorders, attention deficit disorders, movement disorder, speech disorders, abnormal dreams, apathy, loss of sense of direction, confusion, irritability, severe emotional fluctuations, suicide attempt, urination disorders, urgency of urination, enuresis, polyuria, abnormal odor of urine, sexual apathy, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, throat constriction, facial flushing, orthostatic hypotension, peripheral coldness

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain the storage temperature between 15 to 30 degrees Celsius to preserve the medication's effectiveness.

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.

Package unit

28 capsules/PTP