Fluoxetine Hydrochloride Capsule 10 mg

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20～80mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (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 or more of treatment. 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 several months or more of drug treatment. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations 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. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: Use a lower dose or reduce the dosing frequency. Adjust the dose appropriately according to age and symptoms. Switching from MAO inhibitors used to treat 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 to treat psychiatric disorders, at least 5 weeks must elapse after discontinuing this medicine. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition that requires 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 there is no alternative to linezolid or intravenous methylene blue 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 risks of administering methylene blue by a nonintravenous route (oral tablets or local injection), or administering this medicine by intravenous injection at a dose of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This drug is primarily an antidepressant used to treat psychiatric disorders related to depression. Caution must be exercised when prescribing to patients aged 18 to 24, as it may increase the risk of suicidal thoughts or behaviors in this age group. This medication should not be administered to patients who have allergies to this drug or its ingredients, severe renal impairment, or who are currently taking MAO inhibitors. Patients with a history of seizures must use this medication with special care, and treatment should be stopped immediately if seizures occur or increase in frequency. During the initial phase of treatment, there may be a worsening of depressive symptoms or the emergence of dangerous behaviors such as suicidal impulses; therefore, patients and caregivers should carefully monitor these changes and communicate closely with the physician. Since this drug is metabolized and excreted by the liver and kidneys, dosage adjustments may be necessary for patients with impaired liver or kidney function. Diabetic patients should periodically check their blood sugar levels, as this drug may cause changes in blood sugar control. This drug may occasionally cause pupil dilation and increase intraocular pressure, posing a risk to patients with glaucoma. Common side effects include headache, nausea, insomnia, fatigue, diarrhea, and rarer but severe side effects such as allergic reactions or cardiac arrhythmias. Discontinuing this drug suddenly may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and tremors; thus, the dosage should be gradually reduced according to the physician's instructions. This drug may interact with other medications; therefore, patients must inform their physician about any other medications they are taking, especially MAO inhibitors, anticoagulants, some heart medications, or other antidepressants. Pregnant or breastfeeding women should consult a physician before taking this medication and consider the potential risks to the fetus or newborn. The safety and efficacy of this drug in children and adolescents have not been established, and its use is not recommended. Elderly patients should be observed closely due to an increased risk of side effects depending on their other conditions or medications. Finally, this drug should be stored out of reach of children, and patients should not arbitrarily stop or alter their dosage.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought abnormalities, sexual desire abnormalities, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disorders, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, seizures, akathisia, buccoglossal syndrome, serotonin syndrome, memory disorders, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related incidents, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rashes, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myositis, myalgia, frequent urination, dysuria, urinary retention, urinary dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal moods, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver or pulmonary-related reactions, weight loss, growth delay, sexual maturity delay, sexual dysfunction, ejaculation failure, cervical bleeding, uterine dysfunction, uterine bleeding, genital bleeding, dysfunctional uterine bleeding, heavy menstruation, frequent menstruation, postmenopausal bleeding, vaginal bleeding, asthenia, Stevens-Johnson syndrome, suicidal impulses, platelet function changes, abnormal bleeding, 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-mediated hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia

This drug should be stored in a tightly closed container to prevent air or moisture from entering. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius to maintain the drug's efficacy over time.

Appearance

A hard capsule with green upper and lower parts filled with white or grayish-white powder

Package unit

30 capsules/bottle, 500 capsules/bottle