Fluoxetine Extended Release 20 mg (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 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 starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine; however, psychopharmacologists agree that acute episodes of depression require several months or more of drug therapy. 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 medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, 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 psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 this medicine because of the increased risk of serotonin syndrome. For patients requiring 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 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, discontinue this medicine 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 occurs first. Treatment with this medicine 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 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 such use.

This drug should be used cautiously in children or adolescents with major depressive disorder or psychiatric illnesses, as there may be an increased risk of suicidal thoughts and actions. Patients with allergic reactions to this medication or severe renal impairment, as well as those currently taking certain medications (especially MAO inhibitors), should not take this drug. Patients with a history of seizures or a high risk of suicide, those exhibiting manic symptoms, or those with heart disease or hepatic/renal dysfunction should exercise caution when using this drug. Diabetic patients should be aware that changes in blood sugar may occur while taking this drug, thus careful blood glucose control is necessary. This medication may cause eye-related side effects such as pupil dilation, and patients with elevated intraocular pressure should take caution. Common side effects include headache, nausea, insomnia, fatigue, and diarrhea, with potential risks of severe allergic reactions, suicidal thoughts, and cardiac arrhythmias. If this medication is suddenly discontinued, withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea may occur, thus it should be reduced gradually according to a physician's instructions. This drug may interact with other medications, necessitating consultation with a physician, particularly when taken with medications that affect blood coagulation or heart function. During pregnancy, there may be potential risks to the fetus, so it should be used only when necessary, and caution is advised when breastfeeding due to potential drug transfer to the infant. The safety and efficacy of this drug in children and adolescents are not sufficiently established, and its use is not recommended. Elderly patients may be at increased risk for side effects, so caution is warranted. In cases of overdose, symptoms may include nausea, vomiting, seizures, and cardiac arrhythmias, necessitating immediate contact with medical institutions. This medication should be kept out of reach of children and not transferred to other containers.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, neuroexcitation, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disturbances, abnormal libido, 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, tonic-clonic seizures, spasms, inability to sit still, Buccoglosssal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, incidents related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, muscle cramps, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, weakness, nausea, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, reactions related to the kidneys, liver, or lungs, suicidal ideation, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, 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 sealed container to prevent air ingress and should be kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the efficacy of the medication.

Appearance

White rectangular extended release tablet

Package unit

100 tablets (10 tablets/PTP x 10)