Fluoxetine Capsule (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 20～80mg 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 twice daily (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 starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug. However, psychopharmacologists generally agree 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 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 needed. - Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. - Switching to or from an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, 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 treatment with 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. 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 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 a non-intravenous route (oral tablets or local injection) or intravenous administration of this drug 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 may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive or psychiatric disorders, so it should be used with caution. This medication should not be administered to patients with hypersensitivity, severe renal impairment, or those currently taking MAO inhibitors, a specific class of medication. Patients with a history of seizures or high suicidal risk, those with mania or heart disease, patients with impaired liver or kidney function, and diabetic patients should use this medication with caution. Common side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur, and rarely serious side effects such as allergic reactions, severe skin reactions, bleeding, or cardiac arrhythmias may develop. If there are any changes in mental state during the course of taking this medication, such as suicidal thoughts or behaviors, anxiety, agitation, or aggression, contact a doctor immediately. This medication may interact with other drugs, so it is essential to inform your physician or pharmacist about any other medications you are taking, and it is advisable to avoid alcohol intake. Pregnant or breastfeeding women should consult a physician thoroughly before using this medication, as it may affect the fetus or newborn. Safety and efficacy in children and adolescents have not been established, and its use is not recommended. Elderly patients should also take special precautions, and in case of overdose, seek immediate medical assistance. This medication should be kept out of reach of children, and transferring it to other containers should be avoided.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, inappropriate secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, neural hyperexcitability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, derealization, euphoric mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, convulsions, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, respiratory events related to the lungs, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, polyuria, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe reactions related to skin, kidneys, liver, or lungs, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, rash, allergic symptoms, hypoglycemia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesias, 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 restlessness

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication over time.

Appearance

A hard capsule with a pale yellow color containing a white to light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle