Fluoxetine Capsules (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 above 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 treatment begins. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. Do not exceed a daily dose of 80mg. Measure electrolyte concentrations 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. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medicines, older adults, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately 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 medicine, 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 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, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If 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 for 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 for 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 a nonintravenous route (oral tablets or local injection), or with intravenous administration of this medicine at 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 suicidal thoughts or behavior in children, adolescents, and young adults with depression or psychiatric disorders, therefore caution is essential. This medication should not be administered to patients with allergies to this drug or its additives, or severe renal dysfunction, and to those taking certain medications like MAO inhibitors. Patients with a history of seizures or manic symptoms should use this medication with caution, and caution is also required for patients with heart disease or liver and kidney dysfunction. Diabetic patients may experience changes in blood sugar control during treatment and should monitor their blood glucose levels closely. This medication may rarely cause side effects such as headache, nausea, insomnia, fatigue, diarrhea, and hyponatremia, and severe allergic reactions, bleeding, or changes in mental state have also been reported. If symptoms such as suicidal thoughts, aggression, anxiety, or restlessness occur during treatment, consult a physician immediately. This medication has many interactions with other drugs, so patients must inform their physician or pharmacist about all medications being taken. During pregnancy, it should only be used when necessary due to risks to the fetus, and during breastfeeding, the mother should discontinue breastfeeding or consult a physician. Suddenly discontinuing this medication may lead to withdrawal symptoms such as dizziness, anxiety, and headaches; therefore, dosage should be gradually reduced according to a physician's instructions. Caution is needed when driving a car or operating hazardous machinery as this medication may impair judgment and concentration. The safety of this medication has not been sufficiently confirmed in children or adolescents, thus its use is not recommended. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac abnormalities may occur, requiring immediate medical treatment.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, 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 behaviors, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, clonic-tonic cramps, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, urinary frequency, dysuria, urinary retention, voiding dysfunction, 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 disturbances, sleep disturbances, weakness, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, renal, liver, or pulmonary related reactions, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, platelet function changes, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, 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, movement disorders and exacerbation of existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius (room temperature) to preserve the effectiveness and safety of the medication.

Appearance

A hard capsule with a green upper part and a yellowish-white lower part filled with light gray powder

Package unit

30 capsules/bottle, 500 capsules/bottle