Duloxetine 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 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 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 reevaluate 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 above 60mg. Nevertheless, if a dose exceeding 60mg once daily is chosen, it 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 known to be 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 reevaluate 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 above 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, consider initiating treatment at a lower dose and gradually increasing it. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this drug should be assessed individually. The efficacy of treatment with this drug 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 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 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 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 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. For patients who do not respond to the recommended dose (60mg/day), administration of doses above 60mg daily 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 Dosage 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 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 dosage adjustment is necessary for 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 discontinuing treatment 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 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 MAO inhibitors for the treatment of psychiatric disorders A gap of at least 14 days should be allowed between discontinuation of an MAO inhibitor used to treat psychiatric disorders and initiation of treatment with this drug. Conversely, at least 5 days should elapse after discontinuation of this drug 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 should not initiate treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventional procedures should be considered. 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. 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 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 non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the potential for 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 medication is primarily used for treating depression or anxiety disorders, diabetic neuropathic pain, and fibromyalgia. Patients with suicidal tendencies, particularly young adults between the ages of 18 and 24 and adolescents, need careful monitoring when taking this medication. There is a risk of serious side effects known as serotonin syndrome, so caution is advised when used with other serotonin-related drugs. This medication should not be administered to patients with certain liver diseases, untreated high blood pressure, severe kidney impairment, or specific genetic disorders. Blood pressure and heart rate should be monitored periodically during treatment, especially in patients with hypertension or heart disease. Orthostatic hypotension or fainting may occur, so caution is necessary when starting the medication or increasing the dose. Patients taking anticoagulants or medications that affect platelet function should exercise caution due to an increased risk of bleeding. If severe skin rash or allergic reactions occur, the medication should be discontinued immediately, and a doctor should be consulted. There is a potential for hyponatremia (lowered sodium levels), particularly in older adults or patients with dehydration or liver cirrhosis, so caution is necessary. The medication may affect urinary function, leading to difficulty urinating; report any such symptoms to your doctor. Suddenly stopping the medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be tapered off gradually under a doctor's guidance. Dizziness or drowsiness may occur when driving or operating machinery, so caution is advised. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication, and it is advisable to avoid taking it while breastfeeding. The safety and efficacy in children and adolescents under 18 years have not been established, and it should not be used in this population. In cases of overdose, serious symptoms such as coma, increased heart rate, and seizures may occur, requiring immediate emergency treatment. This medication should be stored in its original container, out of reach of children.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, reduced appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorder, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, dyskinesia, restless legs syndrome, low sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, dizziness, ear pain, palpitations, tachycardia, ventricular arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, abdominal distension, 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 reaction, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myoclonus, orofacial dystonia, dysuria, frequency, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow, urine odor changes, 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, hyperkalemia, increased serum cholesterol, acute pancreatitis, anaphylaxis, erythema multiforme, cutaneous vasculitis, gynecological bleeding, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, microscopic colitis, restless legs syndrome, seizures upon discontinuation, supraventricular arrhythmia, trismus, urticaria, worsening of depression, edema, gastric ulcer, discomfort in the head, burning sensation, intellectual disability, intoxication, hiccups, dyspnea, restlessness, abnormal dreams, emotional lability, suicide attempts, overdose

This medication should be stored in a tightly sealed container to protect it from air or moisture and kept in a cool place between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

A hard capsule with a blue upper part and a white lower part containing white to light brown spherical delayed-release granules.

Package unit

28 capsules (14 capsules/PTP x 2)