Eurozac Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride orally once daily in the morning. Doses of 20～80mg per day were administered in controlled clinical trials. If no improvement is observed, a dose increase may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, but psychopharmacologists recognize that acute episodes of depression require medication for several months or longer. It is not known whether the amount of antidepressant required to relieve symptoms is the same as that needed to maintain or sustain improvement. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with comorbid conditions: Use a lower dose or reduce the dosing frequency. Adjust the dose appropriately according to age and symptoms. Switching from or to an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 weeks must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 5 weeks 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 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 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 these uses.

This medication may increase the risk of suicidal ideation and behavior in children, adolescents, and young adults with major depression or psychiatric disorders; therefore, the physician must make a careful judgment regarding the administration of this medication. This medication should not be used in patients with specific diseases or histories, especially in patients currently taking MAO inhibitors, as concomitant treatment is prohibited. Patients with a history of seizures, those at high risk for suicide, patients with a history of mania, and those with heart diseases need to be particularly careful when using this medication. Patients with impaired liver or kidney function may require dose adjustment, and diabetic patients should be cautious as blood sugar control may be affected. Common side effects of this medication include headaches, nausea, insomnia, fatigue, diarrhea, and decreased sodium levels, and severe allergic reactions or skin rashes have also been reported. During the initial administration or when changing the dose, careful observation for worsening depressive symptoms, suicidal ideation, changes in behavior such as aggression should be conducted, and family or guardians should be educated to monitor these changes. This medication may interact with other drugs, so if other medications are being taken, the physician or pharmacist must be informed; especially concurrently using drugs affecting blood coagulation may increase the risk of bleeding. During pregnancy, it should only be used if absolutely necessary, considering the risks to the fetus, and in breastfeeding, since this medication is excreted in breast milk, discontinuation of breastfeeding should be considered. Safety and efficacy in children and adolescents have not been established, and use should be avoided. Elderly patients should also use this medication with caution; if this medication is suddenly discontinued, withdrawal symptoms such as dizziness, anxiety, and headaches may occur, so the dose should be tapered gradually. While taking this medication, caution is required when driving a vehicle or operating dangerous machinery, and alcohol consumption is not recommended. Store this medication in a closed container to protect it from air and moisture, and keep it out of the reach of children. Do not transfer to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, reduced appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, altered taste, hypersomnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, urinary frequency, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal hemorrhage, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, exacerbation of pre-existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication should be stored in a closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness for a prolonged period.

Appearance

A hard capsule filled with white to grayish-white powder with a green upper and lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle