Fluoxetine Capsules (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 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 in 2 divided doses (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 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 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 stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. 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 therapy. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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 to treat 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 more urgent treatment of a psychiatric condition, including hospitalization and other interventions, consider administration. 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 specific patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (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 these uses.

This medication is primarily an antidepressant used for the treatment of psychiatric disorders such as depression. However, during treatment, there may be an increase in suicidal impulses or behaviors; thus, young patients, particularly those aged 18 to 24, should be closely monitored. The use of this medication is not approved for children and adolescents, and it is advisable not to use it in these populations. Patients with allergies to this medication or its additives, severe renal impairment, and those taking certain medications called MAO inhibitors should not receive this medication. Particularly, concomitant use of this drug with MAO inhibitors or crossing between them within a certain period can be dangerous. Patients with a history of seizures, high suicide risk, manic symptoms, heart disease, liver or kidney issues, diabetes, or those at risk of increased intraocular pressure need to be cautious when using this medication. Common side effects include headache, nausea, insomnia, fatigue, and diarrhea, while severe allergic reactions or cardiac arrhythmias have been reported rarely. Additionally, sudden discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, nausea, tremors, and headaches, so it should be tapered down gradually under a doctor's guidance. This medication may interact with other drugs, so patients must inform their doctor or pharmacist of any current medications, and it is advisable to avoid alcohol consumption. Pregnant or breastfeeding women should consult a physician before using this drug, as it may affect the fetus or newborn. It is preferable not to administer this medication to children and adolescents given the lack of established safety and efficacy, and it should also be used cautiously in the elderly. Finally, this medication should be kept out of reach of children and should not be stopped or altered in dosage arbitrarily; always follow a health professional's instructions.

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 abnormalities, abnormal libido, bruxism, mania, hallucinations, agitation, panic attacks, suicidal impulses and actions, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, general muscle cramps, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, cold sweat, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary dysfunction, 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, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe reactions related to the skin, kidneys, liver, or lungs, growth retardation, delayed puberty, sexual dysfunction, hypoglycemia, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, 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, worsening of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, psychomotor agitation, symptoms of serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, hypertonia, general muscle cramps, parpura, coordination disorders, seizures, nausea, vomiting, diarrhea)

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it must be kept at room temperature between 1 to 30 degrees Celsius, not in excessively cold or hot places.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle