Duloxetine Hydrochloride Capsule 30 mg

Adult dosage

Adult 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 above 60mg once daily, and the dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance treatment In general, the therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms improve, continued medication use for several months is recommended to prevent relapse. 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. Although efficacy has been demonstrated at 120mg once daily, there is no evidence of additional benefit at doses above 60mg. Nevertheless, if a dose of 60mg or more once daily is chosen, the dose should be increased in 30mg increments once daily. The safety of doses above 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 The dose of this drug is 60mg once daily, with or without food. Although 120mg once daily is safe and effective, there is no evidence of additional benefit at doses above 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, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Diabetic peripheral neuropathic pain has a variable course, and pain control is empirical; therefore, the effect of this drug should be evaluated individually. The efficacy of treatment with this drug for more than 12 weeks has not been systematically studied in placebo-controlled trials, although 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 additional benefit has been observed at doses above 60mg/day, and administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is known to be a chronic condition. In placebo-controlled trials of fibromyalgia treatment, the efficacy of this drug was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term trials lasting more than 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), administering doses above 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 drugs, caution is needed 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 (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. When discontinuing treatment after more than 1 week of use, it is recommended that the dose be gradually reduced beginning 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken 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 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 discontinuation of 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. In 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 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. 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 nonintravenous routes (oral tablets or local injection) or intravenous injection 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 these uses.

Children's dosage

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 primarily used for the treatment of psychiatric disorders associated with depression. During the use of this medication, particularly in children, adolescents, and young adults, there is an increased risk of suicidal thoughts or behaviors, so doctors should closely monitor the patient's condition. This medication improves symptoms by inhibiting the reuptake of neurotransmitters serotonin and norepinephrine, and there may be a serious side effect called serotonin syndrome, so caution is needed when taken with serotonergic agents. It is particularly contraindicated to use in combination with MAO inhibitors or to use within a certain period. This medication should not be administered to patients with severely impaired liver or kidney function, or those with uncontrolled glaucoma or hypertension. During treatment, side effects such as headaches, dizziness, nausea, dry mouth, and drowsiness can commonly occur, and these symptoms may be more pronounced at the beginning of treatment. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors, so it should be gradually tapered off according to the doctor's instructions. Serious side effects such as elevated blood pressure, orthostatic hypotension, bleeding tendency, liver damage, and severe skin reactions may occur; if any abnormal symptoms arise, the physician should be consulted immediately. Women who are pregnant or breastfeeding should consult with their doctor before taking this medication, as it may affect the fetus or newborn. This medication should be avoided in individuals under 18 years old, as safety and effectiveness have not been established. Elderly patients should use this medication with caution, and especially with high doses, the risk of side effects may increase. In the case of overdose, symptoms such as coma, seizures, or serotonin syndrome can occur, requiring immediate emergency treatment. Finally, this medication should be kept out of the reach of children and stored in its original container to prevent quality deterioration or misuse.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremor, sensory disturbances, myoclonus, restlessness syndrome, neuroexcitability, attention deficit disorder, 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 dysrhythmia, hypertension, flushing, hypotension, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, bloody stools, elevated liver enzyme levels, 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, muscle spasms, jaw opening disorder, dysuria, frequency of urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary 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, elevated serum creatine phosphokinase, increased serum potassium, elevated serum cholesterol, xerostomia, decreased appetite, insomnia, anxiety, abnormal dreams, weakness, headache, tremors, migraine, taste alteration, insomnia, sleep disturbances, orgasm dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, pruritus, facial flushing, elevated serum cholesterol levels, dehydration, hyperlipidemia, dyslipidemia, muscle stiffness, concentration difficulties, abnormal movement disorders, speech disturbances, abnormal dreams, loss of sense of direction, confusion, irritability, severe mood swings, suicide attempt, urination disorders, urinary urgency, enuresis, polyuria, abnormal urine odor, sexual dysfunction, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, yawning, throat tightness, orthostatic hypotension, peripheral coldness, acute pancreatitis, erythema multiforme, extrapyramidal disorders, enuresis, cutaneous vasculitis, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, muscle cramps, seizures upon discontinuation of treatment, supraventricular dysrhythmia, jaw stiffness, urticaria, exacerbation of depression, edema, peptic ulcer, head discomfort, burning sensation, mental retardation, intoxicated state from medication, hiccups, dyspnea

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 15 and 30 degrees Celsius. This will help maintain the drug's efficacy and safety.

Appearance

A hard capsule with an upper blue and lower white part containing white enteric-coated spherical granules.

Package unit

30 capsules/bottle, 100 capsules/bottle