Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 must 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, 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 medicine per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. 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 low dose or reduce the frequency of administration. The dose may be adjusted according to age and symptoms. Switching from or to 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 must 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 interventional procedures, treatment should be considered. It may be necessary to administer linezolid or intravenous methylene blue urgently to a patient who is already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, immediately discontinue this medicine 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with 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 drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults aged 18 to 24 with major depressive disorder or other psychiatric conditions, so physicians should carefully consider whether to prescribe it. This drug should not be used in patients who have previously had allergic reactions to it or its additives, patients with severe renal impairment, or patients currently taking MAO inhibitors, a specific type of psychiatric medication. Patients with a history of seizures should be particularly cautious when using this drug, and treatment should be immediately discontinued if seizures occur or their frequency increases. As this drug may induce suicidal thoughts or behavior in patients with depression, close monitoring of changes in symptoms should occur during the initial treatment phase, and both patients and guardians should be made aware of these changes and encouraged to consult with a physician. Patients with heart disease or cardiac rhythm issues should undergo an ECG before taking this medication and immediately report any cardiac symptoms encountered during use to their physician. Patients with impaired liver or renal function should adjust the dosage of this medication, and diabetic patients should periodically check their blood glucose levels. This drug may cause pupil dilation, so it should be used with caution in patients at risk of increased intraocular pressure or acute glaucoma. This drug contains certain dyes, and patients allergic to these components should take it with caution. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, while serious allergic reactions, hepatitis, and skin reactions can occur infrequently. When discontinuing treatment, do not stop abruptly and reduce the dosage gradually as directed by a physician, as withdrawal symptoms such as dizziness, anxiety, and sleep disturbances may arise. Potential interactions with other medications may occur, so it is vital to inform the physician or pharmacist of any other medications being taken, especially when taken with MAO inhibitors, anticoagulants, or other CNS drugs. During pregnancy, use should be limited to necessary cases considering the risks to the fetus, and in breastfeeding, the drug can be excreted in breast milk, necessitating consideration of weaning. The safety and efficacy of this drug in children and adolescents have not been sufficiently established, so it is best to avoid use whenever possible. No specific unacceptable reactions have been reported in elderly patients; however, monitoring is necessary based on other diseases or medications taken. In cases of overdose, symptoms may include nausea, vomiting, seizures, and cardiac arrhythmias, requiring immediate medical treatment. This drug should be kept out of reach of children and should not be transferred to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, sexual dysfunction, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, 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, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, sweating, alopecia, tendency to bruise easily, cold sweat, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, bladder dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, cold sensations, hot sensations, mucosal bleeding, weight loss, abnormal liver function tests, dizziness, sensory disturbances, sleep disorders, fatigue, agitation, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-mediated hemolytic anemia, renal failure, movement disorders, optice neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This drug may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also important to maintain its efficacy by storing it at room temperature, specifically between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a green upper and lower part containing white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle