Duloxetine Capsule 30mg (Duloxetine Hydrochloride)

Adult dosage

Adults 1) Treatment of major depressive disorder Initial treatment This medication 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, 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 medication has not been clearly established. Maintenance treatment In general, response to antidepressant treatment 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 treatment should be continued. 2) Treatment of generalized anxiety disorder Initial treatment This medication 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, then increased to 60mg once daily. Efficacy was 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 selected, the dose should be increased in 30mg increments 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 medication for generalized anxiety disorder, that is, beyond 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend treatment should periodically reassess the patient to determine whether treatment should be continued. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medication is administered at 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, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, consider starting at a low dose and gradually increasing it. Maintenance treatment Diabetic peripheral neuropathic pain varies in its progression, and pain control is empirical; therefore, the effect of this medication should be assessed individually. Although efficacy with administration 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 treatment The recommended dose of this medication is 60mg once daily. To allow the patient to adjust to the medication, initiate treatment at 30mg once daily for 1 week, then increase to 60mg once daily. Some patients may respond to the starting dose. No evidence of additional benefit has been observed with doses exceeding 60mg/day, even in patients who do not respond to 60mg, 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 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 to continue 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 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. 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 medication for the treatment of osteoarthritis pain for more than 13 weeks 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 120mg daily dose are limited. 4. Patients with hepatic impairment This medication should not be used in patients with liver disease, as hepatic impairment may occur. 5. Patients with renal impairment No dose adjustment is necessary for 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 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, the dose may be reduced by half or taken every other day. However, the specific approach should be determined based on the patient's circumstances, including the duration of treatment and the dose 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 medication. Conversely, at least 5 days should elapse after discontinuing this medication before starting an MAO inhibitor to treat psychiatric disorders. 8. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of 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 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. 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 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 methylene blue administered by a non-intravenous route (oral tablets or local injection) or with intravenous administration of this medication at 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: This medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age because of concerns regarding safety and efficacy. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication may increase the risk of suicidal thoughts and behavior in young individuals with major depressive disorder or psychiatric disorders, so doctors should carefully consider the necessity and risks of treatment. Patients of all ages taking this medication should be closely monitored for unusual behavior changes such as worsening depression, suicidal tendencies, or aggression, and family or caregivers should also observe the patient closely. Severe side effects known as serotonin syndrome may occur with this medication, particularly when used with other serotonergic agents. It is prohibited to use this medication in conjunction with certain MAO inhibitors for the treatment of psychiatric disorders or within a certain time frame after stopping them. Patients with poor liver function or end-stage kidney disease, uncontrolled glaucoma, or hypertension should not use this medication. Patients with mania, epilepsy, cardiovascular diseases, tendencies for bleeding, and the elderly should use this medication with caution. Common initial side effects include nausea, headaches, dry mouth, drowsiness, dizziness, which usually diminish over time. If this medication is suddenly discontinued, withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, and anxiety may occur, so the dosage should be gradually reduced. Blood pressure may increase, so patients with hypertension should regularly monitor their blood pressure, and if it continues to rise, consideration should be given to dosage adjustment or discontinuation. Orthostatic hypotension and syncope may occur, so caution is required when first taking the medication or changing the dose. There is a risk of bleeding, so patients taking anticoagulants or drugs affecting platelet function should be cautious. Severe skin reactions may occur; if there are any abnormal signs, such as rashes or mucosal damage, the medication should be stopped immediately. Liver damage and hepatitis have been reported, so if there are symptoms of liver dysfunction, consultation with a physician is necessary. Caution is needed when driving or operating machinery due to possible sedation or dizziness. This medication should be used cautiously when combined with alcohol or central nervous system depressants, and concurrent use with CYP1A2 inhibitors may increase plasma concentration. The risk to the fetus during pregnancy is unknown, so it should only be used when necessary, while breastfeeding is not recommended as it is excreted in breast milk in small amounts. Safety and efficacy have not been established for use in children and adolescents under 18 years of age. In case of overdose, coma, seizures, serotonin syndrome, etc., immediate emergency treatment is required. This medication should be kept out of reach of children and stored in its original container to prevent 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, reduced libido, anorgasmia, restlessness, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, myoclonic jerks, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, pupillary dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia, elevated blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive emergency, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, increased 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, myotonia, jaw opening disorder, dysuria, increased frequency of urination, nocturia, urinary hesitation, urinary retention, polyuria, decreased urine flow, urine odor abnormality, 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 sensations, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, increased serum potassium, increased serum cholesterol, dry mouth, constipation, insomnia, drowsiness, fatigue, poor appetite, sedation, weakness, palpitations, dizziness, increased sweating, diarrhea, vomiting, blurred vision, decreased appetite, headache, anxiety, tremors, restlessness, thirst, sleep disorders, abdominal pain, emotional lability, worsening depression, abnormal dreams, weight gain, ALT increase, sensory disturbances, edema, cold sweat, hyperhidrosis, rash, AST increase, halitosis, gastric ulcer, gastritis, stomach pain, hypersomnia, discomfort in head, taste abnormalities, burning sensation, mental retardation, restless legs syndrome, delirium, irritability, agitation, apathy, anger, nightmares, suicide attempt, depression, mania, hypersensitivity, warmth sensation, pruritus, urticaria, weight loss, increased serum bilirubin, drug intoxication, overdose, hiccups, respiratory distress, erectile dysfunction, delayed ejaculation, sexual dysfunction, flushing, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal disorder, urinary incontinence, glaucoma, cutaneous vasculitis, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, allergic reactions, hypertensive emergency, microscopic colitis, muscle cramps, restless legs syndrome, seizures upon discontinuation of treatment, supraventricular arrhythmia, orofacial dystonia, urticaria

This medication should be stored in a sealed container to prevent air and moisture access, preferably in a cool place between 15 to 30 degrees Celsius. This way, the effectiveness of the drug can be maintained.

Appearance

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

Package unit

28 capsules/PTP