Fluoxetine Capsule 20mg (Fluoxetine Hydrochloride)

Adult dosage

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 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 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 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 necessary. Patients with renal and/or hepatic impairment, patients receiving multiple drugs, older adults, and patients with concomitant 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, 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 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 and other interventional procedures, consider treatment. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this drug, and there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this drug 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this drug at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with depression or psychiatric disorders, therefore careful evaluation is required before use. Patients with hypersensitivity to this drug, severe renal impairment, and those taking certain types of medication, such as MAO inhibitors, should not be administered this drug. Patients with a history of seizures may have an increased risk of seizures while taking this drug and need to be monitored carefully and discontinue treatment immediately if symptoms occur. Patients at risk of suicide should be closely observed for symptoms during the initial treatment phase or dose adjustment, and family members or caregivers should also carefully monitor the patient's condition. Patients with heart disease or those at risk of QT interval prolongation should have an ECG prior to taking this drug, and treatment should be stopped if abnormalities arise. Patients with impaired liver or kidney function should have their dosages adjusted, and diabetic patients should periodically check their blood sugar control status. This drug may cause pupil dilation; therefore, patients with high intraocular pressure or at risk of glaucoma should exercise caution. Common side effects include headaches, nausea, insomnia, fatigue, diarrhea; if allergic reactions or severe rashes occur, use should be discontinued immediately. Withdrawal symptoms such as dizziness, sensory abnormalities, anxiety, and nausea may occur when discontinuing this drug, so dosage should be reduced gradually. There are many drug interactions, particularly with MAO inhibitors, serotonergic agents, anticoagulants, and certain heart medications, so caution is needed when combining these. During pregnancy, the risks and benefits to the fetus should be carefully considered, and if breastfeeding, consultation with a specialist is necessary as this drug can be secreted in breast milk and affect the baby. Safety and efficacy have not been established for children and adolescents, so use is not recommended. Elderly patients should use this drug cautiously, considering other diseases or medications they may be taking. In cases of overdose, severe symptoms such as nausea, seizures, and cardiac arrhythmias may occur, necessitating immediate medical attention. Caution is needed when driving or operating dangerous machinery while on this medication, and alcohol consumption should be avoided. This drug must be kept out of reach of children, and transferring it to other containers can increase the risk of quality deterioration or accidents.

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, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor hyperactivity, movement disorders, ataxia, balance disorders, transient muscular cramps, convulsions, inability to remain seated, 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, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, sensation of cold, sensation of heat, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, renal, hepatic, or pulmonary-related reactions, suicidal ideation, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, exacerbation of pre-existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This drug should be stored in a tightly sealed container to avoid exposure to air or light. A storage temperature of 1 to 30 degrees Celsius is recommended.

Appearance

A hard capsule with a green upper part and a white lower part filled with a white to off-white powder.

Package unit

For domestic use - 30 capsules/bottle, for domestic use - 200 capsules/bottle, for export - 30 capsules/box [10 capsules/PTP × 3]