Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20～80 mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg daily should be administered twice daily (morning and noon), and the maximum dose of 80 mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine; however, psychopharmacologists recognize that acute symptoms 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 the amount needed to maintain or continue stability. 2. Bulimia nervosa Administer 60 mg of this medicine daily. The daily dose should not exceed 80 mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60 mg of this medicine daily. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine daily. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to MAO inhibitors 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 treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, consider administering this medicine. 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 resumed 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 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 such use.

This medication is primarily used for the treatment of psychiatric disorders such as depression. However, it should be used with extreme caution in children, adolescents, and young adults aged 18 to 24, as it may increase the risk of suicidal impulses or behaviors. Patients who are allergic to this medication or its excipients or those with severe renal dysfunction should not take it. Additionally, patients currently taking or who have recently discontinued MAO inhibitors, a specific type of medication, may be at risk when using this medication. This medication should be used cautiously in patients with a history of seizures, and if seizures worsen, it should be discontinued immediately. Close monitoring is required for depressed patients with suicidal impulses or manic symptoms when using this medication. Patients with heart disease or issues with liver or kidney function should also use this medication cautiously, and the doctor may adjust the dosage as needed. Diabetic patients should monitor their blood glucose levels regularly as there may be changes in their control. This medication can dilate pupils, increasing intraocular pressure, so patients at risk for glaucoma should be cautious. Common side effects may include headaches, nausea, insomnia, fatigue, and diarrhea, but serious allergic reactions or liver dysfunction can occur infrequently. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, vomiting, and tremors, so it should be gradually reduced under a doctor’s guidance. This medication can interact with other medications; therefore, patients taking other medications should inform their doctor or pharmacist. During pregnancy, it should only be used when absolutely necessary considering risks to the fetus, and caution is needed during breastfeeding as this medication may be excreted in breast milk affecting the baby. Safety and efficacy have not been established in children and adolescents, hence it is not recommended. Elderly patients should be cautious as there may be a risk of side effects due to other illnesses or medications. In case of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmia may occur, necessitating an immediate visit to a medical facility. This medication should be stored out of the reach of children and not transferred to other containers for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, loss of appetite, hyponatremia, anxiety, neuroexcitation, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbance, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency to bruise easily, cold sweat, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, micturition disorders, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbance, sleep disorders, weakness, agitation, anxiety, nausea, vomiting, tremors, headache, anaphylactic reaction, gradual systemic reactions, suicidal ideation, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic 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 tightly closed container to prevent entry of air or moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle