Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 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 daily were administered. If no improvement is observed, an increase in dosage may be considered after several weeks. Doses greater than 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily 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 recognize that acute episodes of depression require pharmacotherapy for several months or longer. It is not known whether the dose of an antidepressant needed to relieve symptoms is the same as that needed to maintain or continue remission. 2. Bulimia nervosa Administer 60mg of this drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid 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. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 stopped 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at doses 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 should be used with caution in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, as the risk of suicidal thoughts and behaviors may increase. Patients with hypersensitivity to this medication or its additives, those with severe renal impairment, and those taking MAO inhibitors should not use this medication. Patients with a history of seizures should use this medication carefully and immediately discontinue treatment if seizures occur or their frequency increases. Patients at risk of suicide should be closely monitored during the initiation of treatment and upon any dosage changes, with family members or caregivers also closely observing the patient. Patients with a history of mania or hypomania should be cautious with this medication, and treatment should be stopped if symptoms of mania appear. Patients with heart disease or at risk of QT interval prolongation should undergo an ECG before using this medication and should stop treatment if arrhythmia symptoms emerge. Patients with impaired liver or kidney function may need a dosage adjustment, and those with severe renal impairment should avoid using this medication. Diabetic patients may be affected in blood sugar control, so blood glucose should be monitored regularly, and medication dosage should be adjusted if necessary. Patients at risk of increased intraocular pressure or acute glaucoma should be cautious as this medication may cause pupil dilation. Common side effects include headache, nausea, insomnia, fatigue, diarrhea, etc., and treatment should be stopped immediately if severe allergic reactions or skin rashes occur. To prevent sudden withdrawal symptoms upon discontinuation, the dosage should be gradually reduced instead of stopping abruptly. This medication may interact with other drugs; therefore, inform your doctor or pharmacist about any other medications being taken, especially that MAO inhibitors cannot be used concurrently. During pregnancy, this medication should be used only when absolutely necessary as there may be potential risks to the fetus, and if breastfeeding, consultation with a professional is necessary as it may be distributed in breast milk and affect the baby. It is generally advised not to use this medication in children or adolescents due to insufficient evidence of safety and efficacy. Elderly patients should use this medication cautiously due to the risk of side effects depending on their physical condition. In cases of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, requiring immediate medical attention. This medication should be stored 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, neuromuscular irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, hypertonic muscle spasms, convulsions, akathisia, buccoglosso-pharyngeal syndrome, serotonin syndrome, memory disturbances, blurred vision, pupillary dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary 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, petechia, photosensitivity, purpura, erythema multiforme, arthralgia, muscle cramps, myalgia, increased urinary frequency, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, 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 disturbance, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver, or pulmonary-related reactions, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-mediated 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, withdrawal symptoms, sensory disturbance, nightmares, insomnia, intense dreams, weakness, agitation, anxiety, nausea, vomiting, tremors, headache, akathisia, panic disorder, excitement, hostility, aggression, impulsivity, hypomania, mania

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to keep it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a pale yellow top and bottom, containing a white to light gray powder.

Package unit

For internal use - 30 capsules/bottle, For internal use - 100 capsules/bottle