Duloxetine Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial dose This medication 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 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/day, and the dose-response relationship for the efficacy of this medication has not been clearly established. Maintenance dose 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 recurrence. The physician should periodically reassess the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial dose This medication 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 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 exceeding 60mg once daily is prescribed, the dose should be increased in 30mg increments 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 medication 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 medication should periodically reassess the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial dose This medication 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 concerns about tolerability, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance dose The effect of this medication should be evaluated individually because diabetic peripheral neuropathic pain has a variable course and pain control is empirical. Although efficacy with administration of this medication 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 medication is 60mg once daily. To allow the patient to adjust to the medication, 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. 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 dose Fibromyalgia is considered a chronic condition. In placebo-controlled trials of fibromyalgia treatment, the efficacy of this medication 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 medication 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), doses exceeding 60mg/day provide no additional benefit and are associated with a higher incidence of adverse reactions. Maintenance dose The safety and efficacy of administration of this medication 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 is required during treatment, particularly because clinical data on the use of a dose of 120mg/day are limited. 4. Patients with hepatic impairment Because hepatic impairment may occur, this medication 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 medication 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 medication, 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 medication use, gradual dose reduction beginning 2 weeks beforehand is recommended to reduce the risk of withdrawal symptoms. During this period, reduce the dose by half or take the medication 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 an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 days must have elapsed after discontinuation of this medication. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for 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 a patient already receiving this medication. 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 medication 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 medication 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 intravenous administration of this medication 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 these uses.

Children's dosage

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

This drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Therefore, when used in this age group, doctors must carefully assess the risks and benefits. All patients taking this medication should be closely monitored for any worsening of symptoms, suicidal thoughts, aggression, rage, or any abnormal behavioral changes after treatment initiation, and family members or caregivers should also closely observe the patient and consult a doctor if any abnormalities are noted. This medication carries a risk of developing life-threatening serotonin syndrome when combined with other serotonergic drugs, so it should not be used with MAO inhibitors, and patients must be carefully monitored for signs of serotonin syndrome during co-administration. People with certain conditions such as liver disease, end-stage renal disease, uncontrolled glaucoma or hypertension should not take this medication, and it should also be avoided in cases of hypersensitivity. Patients with a history of mania or bipolar disorder, epilepsy, hypertension, or heart disease, as well as those who are prone to bleeding or are on anticoagulants should be given this medicine with caution. Common side effects of this medication include nausea, headache, dry mouth, drowsiness, and dizziness, mainly occurring early in treatment and tend to alleviate with time. If the treatment is abruptly stopped, withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and tremors may occur, so the dose should be gradually reduced according to the doctor's instructions. During treatment, increases in blood pressure and heart rate may occur, so blood pressure and heart status should be checked periodically, as postural hypotension and fainting symptoms should also be monitored. This medication may increase the risk of bleeding, so caution is needed for patients with bleeding tendencies or those on anticoagulants, NSAIDs, or aspirin. Severe liver damage, including fatal liver failure, has been reported, so if symptoms of liver dysfunction occur, immediate consultation with healthcare providers is necessary. Care should be taken during driving or operating dangerous machinery as drowsiness or dizziness may occur. During pregnancy, potential risks to the fetus exist, so it should only be taken if necessary, and during breastfeeding, it is not recommended as this medication is excreted in small amounts in breast milk. In children and adolescents under 18 years, safety and efficacy have not been established, and it is generally not recommended for use, but if clinically necessary, careful monitoring for signs of suicidal symptoms should be carried out. In case of overdose, serious symptoms such as coma, seizures, and serotonin syndrome may appear, so immediate emergency treatment is necessary if overdose is suspected. This medication should be stored out of the reach of children and kept in its original container to prevent quality degradation.

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 thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, somnolence, tremors, sensory disturbances, myoclonic jerks, akathisia, irritability, attention deficit, taste disturbances, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, ventricular arrhythmias, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, fainting, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stools, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reactions, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, muscle spasms, jaw opening disorder, dysuria, urinary frequency, 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 sensation, malaise, thirst, abnormal sensations, chills, gait disorders, weight loss, weight gain, elevated serum creatine phosphokinase, elevated serum potassium, elevated serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, hyperhidrosis, cutaneous vasculitis, microscopic colitis, supraventricular arrhythmias, trismus, hypotension, onychomycosis, worsening depression, edema, gastric ulcer, head discomfort, burning sensation, mental retardation, drugged state, hiccups, respiratory distress, akathisia, abnormal dreams, mood swings, suicide attempts, overdose

This medication may be sensitive to air or moisture, so it should be stored in a closed container. Additionally, to maintain its efficacy, it is best to store it at a cool temperature between 15 to 30 degrees Celsius.

Appearance

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

Package unit

28 capsules (14 capsules/PTP x 2)