Flumin Capsule (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: Administer fluoxetine hydrochloride 20mg orally once daily in the morning as the initial dose. In controlled clinical trials, doses of 20～80mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. 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 the acute symptoms 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 remission. 2. Bulimia nervosa Administer 60mg of this medicine daily. Do not exceed a daily dose of 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. Do not exceed a daily dose of 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients receiving multiple medicines, 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 or to an MAO inhibitor used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for treatment of 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 requiring 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, this medicine 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 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 non-intravenous administration of methylene blue (oral tablets or local injection) or 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 medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; therefore, careful observation is required during administration. It should not be used in patients with hypersensitivity to this drug or its excipients, patients with severe kidney impairment, and those taking MAO inhibitors. Caution should be exercised in patients with a history of seizures, as this medication may increase the risk of seizures; if seizures occur or frequency increases, discontinuation is necessary. Patients at risk of suicide should be closely monitored, especially at the beginning of treatment and during dosage changes, and family or caregivers should also carefully observe the patient's condition. This medication should be used cautiously in patients with a history of mania or hypomania, as it may worsen manic symptoms. Patients with heart disease or risk factors for QT interval prolongation should undergo ECG testing, and administration should be immediately stopped if symptoms of arrhythmia occur. Dosage adjustments may be needed for patients with impaired liver or kidney function. Diabetic patients may be affected in blood sugar control and should periodically check their blood sugar levels, adjusting medication as needed. This medication may cause pupil dilation, so patients at risk of increased intraocular pressure or acute glaucoma should be cautious. Common side effects during administration may include headaches, nausea, insomnia, fatigue, diarrhea, so symptoms should be monitored. Abruptly stopping this medication may cause withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, tremors, headaches, so it is important to reduce the dose gradually. If allergic reactions or severe rashes occur, consult healthcare professionals immediately. This medication may affect blood coagulation, so patients with bleeding risks or on anticoagulants should exercise caution. During treatment, there may be a decline in judgment or motor function, so caution is advised when driving a vehicle or operating hazardous machinery. This medication may interact with other drugs; inform healthcare professionals of all medications being taken, especially when combined with MAO inhibitors, serotonin-acting medications, or anticoagulants. Women who are pregnant or nursing should consult their doctor before using this medication, as it may affect the fetus or newborn. Safety and efficacy in children and adolescents has not been established, so administration is not recommended. Elderly patients may be at increased risk of adverse reactions due to comorbidities or concurrent medications, so use with caution. Overdosage may cause symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias, necessitating immediate medical attention. This medication should be kept out of the 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, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, feeling of happiness, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic contraction, cramps, 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, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reaction, 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, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, nausea, vomiting, tremor, headache, anaphylactoid reaction, progressive systemic reaction, severe reactions related to the skin, kidneys, liver, or lungs, hyponatremia, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

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

Appearance

A hard capsule with a green upper part and a light yellow lower part containing white to light gray powder

Package unit

30 capsules/bottle, 500 capsules/bottle