Duloxetine Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial dose This medicine 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 medicine has not been clearly established. Maintenance dose 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 relapse. The physician should periodically reevaluate the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial dose This medicine 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 of more than 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 dose Generalized anxiety disorder is generally considered a chronic condition. The efficacy of long-term use of this medicine 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 medicine should periodically reevaluate the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial dose This medicine is administered at a dose of 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, initiation at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, initiation at a lower dose followed by gradual dose increases should be considered. Maintenance dose Because diabetic peripheral neuropathic pain has a variable course and pain control is empirical, the effect of this medicine should be assessed individually. Although efficacy with administration of this medicine 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 dose The recommended dose of this medicine 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 dose Fibromyalgia is considered a chronic condition. The efficacy of this medicine in placebo-controlled fibromyalgia treatment trials 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 dose The recommended dose of this medicine 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. For 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 dose The safety and efficacy of this medicine for administration exceeding 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 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 Because hepatic impairment may occur, this medicine should not be used in patients with liver disease. 5. Patients with renal impairment No dose adjustment is necessary for 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 discontinuing treatment 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, reduce the dose by half or take the medicine 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 MAO inhibitors used to treat psychiatric disorders At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 5 days should elapse after discontinuing this medicine before initiating an MAO inhibitor for the treatment of psychiatric disorders. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for 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 preparations to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available, 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 medicine 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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 This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns regarding its safety and efficacy. 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 psychiatric disorders related to depression. During the use of this medication, especially among younger individuals aged 18 to 24, there may be an increased risk of suicidal impulses or behavior, so healthcare providers must exercise caution before prescribing, and patients and guardians should carefully observe for any changes in behavior. Furthermore, this medication can cause a serious condition called serotonin syndrome, which is more likely to occur when taken with certain other medications. Therefore, it is essential to consult with a doctor before starting combination therapy. This medication should not be given to patients with severely impaired liver or kidney function, uncontrolled hypertension, severe glaucoma, or specific metabolic disorders related to sugars. During administration, regular monitoring of blood pressure and heart rate is necessary, and caution is required as symptoms of orthostatic hypotension or fainting may occur. There is an increased risk of bleeding; patients taking anticoagulants or those with bleeding tendencies should be especially cautious. Withdrawal symptoms such as dizziness, anxiety, and sleep disturbances can commonly occur upon sudden cessation of this medication, so it is important to gradually taper off under a doctor's guidance. Women who are pregnant or breastfeeding should always consult with a physician before taking this medication, as side effects may occur in newborns, especially in late pregnancy. This medication is generally not recommended for use in children and adolescents due to insufficient evidence of safety and efficacy. Drowsiness or dizziness may occur while on this medication, hence caution is necessary when driving or operating hazardous machinery. In case of overdose, severe symptoms such as coma, seizures, and serotonin syndrome may occur, and immediate medical attention should be sought. This medication should be stored in its original container and kept out of reach of children.

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 disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, hypersomnia, tremor, paresthesia, tics, restless leg syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, cardiac dysrhythmia, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, pharyngeal tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stool, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity, cold sweats, tendency to bruise easily, Steven-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myoclonus, trismus, dysuria, frequent urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculatory dysfunction, 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, increased serum potassium, increased serum cholesterol, weakness, migraine, taste disorders, concentration issues, dyskinesia, speech disorders, abnormal dreams, loss of orientation, confusion, irritability, severe mood swings, suicide attempts, urinary disorders, urgency of urination, nocturnal enuresis, polyuria, abnormal urine odor, sexual aversion, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, facial flushing, orthostatic hypotension, peripheral coldness, acute pancreatitis, anaphylaxis, erythema multiforme, overflow incontinence, cutaneous vasculitis, hyperprolactinemia, hypersensitivity reactions, microscopic colitis, seizures upon drug withdrawal, supraventricular dysrhythmias, trismus, urticaria, worsening depression, edema, gastric ulcer, discomfort in the head, burning sensation, mental retardation, increased serum bilirubin, intoxication from medication, overdose, hiccups, respiratory distress

This medication should be stored in a tightly closed container to protect it from air and moisture, and the storage temperature should be maintained between 15 to 30 degrees Celsius. This helps to preserve the medication's effectiveness and prevent deterioration.

Appearance

A hard capsule with an upper purple part and a lower yellow-green part containing spherical granules that are white to light brown and enteric-coated.

Package unit

30 capsules/bottle, 100 capsules/bottle, 200 capsules/bottle