Fluoxetine Capsule (Fluoxetine Hydrochloride)

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 daily were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses greater than 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily 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 drug, but psychopharmacologists generally agree that the 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 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. After 6 months of treatment, reevaluate whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to the patient's 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, an interval of at least 14 days must be allowed. 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 start this drug because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent 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, in 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. Patients should be monitored 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 administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses 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 primarily used to treat depression and psychiatric disorders. This medication may increase the risk of suicidal impulses or behavior, especially in young populations aged 18 to 24, so when administering to this age group, the physician must carefully evaluate the risks and benefits. This drug should not be used in patients with hypersensitivity, severe renal impairment, or those taking certain medications such as MAO inhibitors. Patients with a history of seizures should be cautious when using this drug, and treatment should be stopped immediately if the frequency of seizures increases. Additionally, patients at high risk for suicide require closer monitoring at the start of treatment. Patients with heart disease or a tendency for prolonged QT intervals should also be cautious when using this medication, and dose adjustments may be needed for patients with impaired liver and kidney function. For diabetes patients, this drug may affect blood sugar control, so blood sugar levels should be monitored carefully. This drug can rarely cause pupil dilation, thus caution is needed for patients at risk for increased intraocular pressure or glaucoma. During treatment, side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may commonly occur, and rarely, severe side effects such as allergic reactions or cardiac arrhythmias may happen. Particularly at the beginning of treatment or with dosage changes, mental changes such as suicidal impulses or behavior, aggression, and anxiety may occur, hence patients and caregivers should carefully observe these symptoms and consult a physician immediately if any abnormalities arise. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, nausea, tremors, and headaches; therefore, the dosage should be gradually decreased per a physician’s instructions. Due to potential interactions with other drugs, it is essential to inform healthcare providers about other medications being taken, particularly avoiding concomitant use with MAO inhibitors or serotonergic medications. During pregnancy, there may be risks to the fetus, so it should only be used when absolutely necessary, and caution is advised during breastfeeding as the medication can be transmitted through breast milk. There is no established safety and efficacy in children and adolescents, so it is recommended not to use in this age group. The elderly may be at risk for side effects depending on their physical condition; caution is warranted. In cases of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, necessitating immediate medical attention. This medication should be kept out of reach of children, and transferring it to other containers can lead to accidental ingestion or quality deterioration.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbance, hypersomnia, drowsiness, tremors, psychomotor hyperactivity, movement disorder, ataxia, balance disorder, myoclonic jerks, seizures, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency to bruising, diaphoresis, angioedema, petechiae, phototoxic reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urine retention, urinary disturbances, 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 ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe reactions related to skin, kidneys, liver, or lungs, weight loss, growth retardation, delayed sexual maturation, sexual dysfunction, hypoglycemia, platelet function changes, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, 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, exacerbation of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding of the skin

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be kept at room temperature between 1 degree and 30 degrees Celsius for safety.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle