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 the 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 more after the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but 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 the amount 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 concentrations 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older 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, 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 discontinuation of 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 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. Patients should be monitored 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 drug 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 drug at 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 used primarily as an antidepressant to treat psychiatric disorders such as depression. It may increase the risk of suicidal thoughts or behaviors in young patients particularly between the ages of 18 and 24, therefore administration in this age group should be done very cautiously. This medication should not be used in patients with hypersensitivity, severe renal impairment, or those taking certain types of medications such as MAO inhibitors. Patients with a history of seizures should be given this medication with caution, and if seizures worsen or increase in frequency, the administration should be discontinued. Patients at risk for suicide and those exhibiting manic symptoms should also use it cautiously and consult a doctor immediately if symptoms arise. Patients with heart disease or who are at risk for QT interval prolongation should undergo an ECG before starting this medication. Patients with impaired liver or renal function may require dosage adjustments. Patients with diabetes should be careful as their blood sugar control may be affected. This medication can rarely cause pupil dilation, so it should be used with caution in patients at risk of increased intraocular pressure or glaucoma. Common side effects may include headache, nausea, insomnia, fatigue, diarrhea; if severe allergic reactions or skin rashes occur, treatment should be discontinued immediately. Stopping the medication abruptly can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep issues, and anxiety, so the dosage should be decreased gradually according to a doctor's instructions. This medication can interact with other drugs, so patients should definitely inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should consult a doctor thoroughly before using this medication as it may affect the fetus or newborn, so careful consideration is needed. Safety and efficacy in pediatric and adolescent populations has not been sufficiently established, so administration is not recommended. Elderly patients should be cautious as the risk of side effects may increase depending on other conditions or medications they are taking. In case of overdose, serious symptoms such as cardiac abnormalities, seizures, or coma can occur, and immediate medical attention is necessary. This medication should be kept out of reach of children, and transferring it to another container should be avoided to maintain quality.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, abnormal thinking, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory disorders, blurry vision, pupillary dilation, 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, tendency to bruising, cold sweat, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, persistent erection, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behavior, behaviors related to suicide, hostility, growth delay, ejaculation failure, ejaculation disorders, premature ejaculation, delayed ejaculation, retrograde ejaculation, cervical bleeding, uterine dysfunction, uterine bleeding, genital bleeding, functional uterine bleeding, menorrhagia, frequent menstruation, postmenopausal bleeding, vaginal bleeding, weakness, Stevens-Johnson syndrome, toxic epidermal necrolysis, platelet function changes, abnormal bleeding, 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, hepatic 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, anxiety, agitation, panic disorder, excitement, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, akathisia, psychomotor restlessness

This medication may be sensitive to air or humidity, so it should be kept in a tightly closed container at room temperature. Avoid placing it in excessively hot or cold areas and store it in a cool place away from direct sunlight.

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