Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

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 daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. Onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists generally agree that acute episodes of depression require several months or longer 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 drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. Reassess whether continued treatment is needed after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this drug. - 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. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment 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 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. 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 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 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 is primarily used as an antidepressant for treating psychiatric disorders related to depression. When taking this medication, careful observation is required as the risk of suicidal impulses or behavior may increase, especially in children, adolescents, and young adults. It should not be used in patients with hypersensitivity or severe kidney dysfunction, as well as those taking certain medications such as MAO inhibitors. Patients with a history of seizures may have an increased risk of seizures while taking this medication, so it should be used with caution, and treatment should be discontinued immediately if symptoms occur. This medication can affect the heart, so patients with heart disease or arrhythmias need an electrocardiogram prior to use and careful observation during treatment. Patients with decreased liver and kidney function may need dose adjustments. Diabetic patients may experience changes in blood sugar control, so they should frequently check their blood sugar and adjust the medication dosage if necessary. Patients with high eye pressure or at risk for glaucoma should also be cautious. Common side effects may include headache, nausea, insomnia, fatigue, and diarrhea, while rare but serious allergic reactions, skin rashes, bleeding, and psychological changes may occur. When discontinuing this medication, do not stop suddenly but gradually reduce the dosage according to the physician's instructions, as withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea may occur. This medication can interact with other drugs, so if other medications are being taken, it is essential to inform the physician or pharmacist, especially when taking drugs that affect blood coagulation or other psychiatric medications. Women who are pregnant or nursing should consult a physician before using this medication as it may affect the fetus or newborn. It is not recommended for children or adolescents as safety and efficacy have not been adequately established. Elderly patients may be at increased risk of adverse reactions depending on other conditions or medications, so caution is advised.

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, derealization, elevated mood, happy mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal ideation and behavior, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disturbances, tics, spasms, inability to sit still, Bucco-Glossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupillary 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, tendency to bruise, cold sweat, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, urgency, 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 bleeding, weight loss, abnormal liver function tests, suicidal thoughts, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver or lung-related reactions, weight loss, growth delay, hyponatremia, platelet function changes, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, inability to sit still, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding of the skin

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Furthermore, it should be kept away from excessive heat or cold, ideally stored at room temperature between 1°C and 30°C.

Appearance

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

Package unit

30 capsules/bottle, 200 capsules/bottle