Fluoxetine Capsule (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: Administer 20mg of fluoxetine hydrochloride orally once daily in the morning as the initial dose. 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 longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists recognize that acute episodes of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug. Conversely, allow at least 5 weeks after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with non-intravenous administration of methylene blue (oral tablets or local injection), or with 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 drug is mainly used to treat mental health issues such as depression. During the use of this medication, particularly in children, adolescents, and young adults aged 18 to 24, there is a risk of increased suicidal thoughts or behavior, so careful observation is required. This medication should not be used in patients with an allergy to it or those with severe kidney dysfunction, or in patients taking certain medications (MAO inhibitors). Patients with a history of seizures must be cautious when taking this medication, and if seizures occur or increase in frequency, treatment should be stopped immediately. Patients with depression may show changes such as suicidal thoughts or behavior, aggression upon initial treatment or dose adjustment, so family members or caretakers should observe them closely. Patients with heart disease or those at risk for QT interval prolongation need an electrocardiogram before administration and should stop treatment if any adverse symptoms occur. Patients with liver or kidney impairment should use the medication cautiously with a reduced dose. Diabetic patients should frequently check blood glucose levels as there may be changes in blood sugar control and adjust drug doses if necessary. This medication may cause pupil dilation, which poses caution for patients with high intraocular pressure or at risk for glaucoma. The most common side effects include headache, nausea, insomnia, fatigue, and diarrhea, and if severe allergic reactions or skin rashes occur, consultation with a doctor should be sought immediately. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors; thus, the dose should be gradually reduced as per the physician's instructions. Combining this drug with other medications or consuming alcohol may cause interactions, so patients should consult with their doctor or pharmacist. Women who are pregnant or breastfeeding should carefully consider the potential effects on the fetus or newborn when taking this medication, and if breastfeeding, should stop or use the minimal effective dose. The safety and efficacy in children and adolescents have not been sufficiently established, hence its use is not recommended. Elderly patients may have an increased risk of side effects depending on other underlying conditions or medications, and therefore, caution is needed. In case of overdose, serious symptoms such as vomiting, seizures, and cardiac irregularities may occur, requiring immediate medical treatment.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, loss of appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disturbances, ataxia, balance disorders, tonic-clonic spasms, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flush, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, sweating, increased tendency to bruise, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, suicidal ideation, suicidal behavior, 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, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication should be stored in a tightly sealed container to prevent air or moisture exposure. Additionally, it is recommended to keep the medication at room temperature between 1°C and 30°C. It is safe to avoid extremely hot or cold places.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle