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/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/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 medicine; however, psychopharmacologists recognize that acute episodes of depression require several months or more of drug treatment. 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 60 mg/day of this medicine. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching to or from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment should be considered. 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 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 methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous doses of this medicine of 1 mg/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 used to treat psychiatric disorders such as major depression, and caution is needed as there may be an increased risk of suicidal thoughts and behaviors, especially in children, adolescents, and young adults aged 18 to 24. Before taking this drug, it is essential to check for any allergies to this drug or its additives, any serious renal dysfunction, and whether an MAO inhibitor is being taken. Patients with a history of seizures, suicidal tendencies, past manic episodes, heart disease, liver impairment, or kidney dysfunction require careful observation and caution when using this drug. Since this drug may affect blood sugar control, diabetic patients should regularly monitor their blood glucose levels, and dosage adjustments of insulin or oral hypoglycemic agents may be necessary. This drug can dilate the pupils, potentially increasing intraocular pressure, so patients at risk for glaucoma should be cautious. Common side effects include headache, nausea, insomnia, fatigue, and diarrhea, while serious allergic reactions, skin rashes, liver function abnormalities, and cardiac arrhythmias can occur in rare cases. If suicidal thoughts or behaviors, anxiety, agitation, aggression, or anger arise during treatment, consult a doctor immediately. In the case of pregnancy or breastfeeding, consult a doctor before taking this medication as it may affect the fetus or newborn, and carefully consider the risks and benefits of drug use during breastfeeding. Due to numerous interactions with other medications, caution is required when used with MAO inhibitors, serotonin-acting drugs, anticoagulants, antidepressants, and specific heart medications. This drug may cause withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and headache if abruptly discontinued, so dosage should be gradually reduced under a doctor's guidance. Caution is needed as this drug may impair judgment or motor function when driving or using hazardous machinery. Store this drug out of reach of children and do not transfer it to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste abnormalities, somnolence, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, hypertonic muscle spasms, seizures, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency for increased bruising, diaphoresis, angioedema, petechiae, photodermatosis, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, restless mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, asthenia, restlessness, anxiety, tremor, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver, or lung-related reactions, suicidal ideation, suicidal behavior, hostility, manic reactions, growth retardation, ejaculation failure, cervical bleeding, uterine dysfunction, asthenia, Stevens-Johnson syndrome, hemorrhagic diarrhea, melena, gastric ulcer bleeding, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This drug should be stored in a tightly sealed container to avoid contact with air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius. This will help maintain the drug's effectiveness and safety over time.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle