Fluoxetine Hydrochloride Capsules

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 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 twice daily (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 drug; however, 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. Do not exceed 80mg per day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug per day. Do not exceed 80mg per day. 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, elderly patients, and patients with comorbid illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from an MAO inhibitor used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, allow an interval of at least 14 days. Conversely, if starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks must elapse after discontinuing this drug. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or an intravenous methylene blue preparation should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, or other interventional procedures, consider treatment. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this drug. 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 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 restarted 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 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 medication is primarily used as an antidepressant for treating mental disorders such as depression. It may increase the risk of suicidal thoughts or behavior, especially in young people aged 18 to 24, so it must be prescribed with extreme caution in this age group. It should never be administered to patients with a history of allergies to this drug or its components, severe renal impairment, or those taking certain medications known as MAO inhibitors. Special caution is necessary for patients with a history of seizures, high suicide risk, manic symptoms, cardiovascular conditions, or impaired liver and kidney function, and symptoms must be closely monitored during administration. In diabetic patients, this medication may worsen glycemic control, necessitating frequent blood sugar monitoring and treatment adjustments if needed. This medication may dilate pupils, requiring caution in patients with a risk of increased intraocular pressure or glaucoma. Common side effects include headache, nausea, insomnia, fatigue, diarrhea, and while severe allergic reactions, bleeding, and cardiac arrhythmias may occur, patients should immediately consult healthcare professionals if any of these symptoms arise. Sudden discontinuation can lead to withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, nausea, shaking, so doses should be gradually reduced following a doctor's instructions. This drug may pose a risk of serotonin syndrome if taken in conjunction with other serotonergic agents, necessitating special caution when used simultaneously. During pregnancy, it may pose potential risks to the fetus and should only be used when absolutely necessary, while breastfeeding as it may be excreted in milk affecting the infant, necessitating thorough discussion with a doctor regarding treatment necessity. Its safety and efficacy in children and adolescents have not been sufficiently established, so it is advisable to avoid use. Although no specific adverse reactions have been reported in the elderly, considering other health conditions or concurrent medications is essential for cautious use. In case of overdose, severe symptoms such as nausea, vomiting, seizures, arrhythmias, and coma may occur, requiring immediate emergency treatment. This medication may affect judgment and reaction time when driving or operating hazardous machinery, so caution is advised, and alcohol consumption should be avoided. Before taking any other medications, herbal products, or over-the-counter drugs, consultation with a healthcare provider or pharmacist is mandatory. It should be stored out of reach of children and not transferred to other containers for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, abnormal libido, teeth grinding, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disorders, dizziness, taste disorders, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, convulsions, inability to sit still, buccolingual syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency for increased bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myalgia, increased urinary frequency, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver, or lung-related reactions, weight loss, growth delay, delayed sexual maturation, sexual dysfunction, hyponatremia, platelet function changes, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, 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, akathisia, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding of the skin, postpartum hemorrhage, akathisia, psychomotor restlessness

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance

For domestic use: opaque capsules containing a white to light gray powder with a pale yellow upper and lower part. For export: capsules with a green upper part and a light yellow lower part containing grayish-white powder.

Package unit

Domestic: 30 capsules/bottle, 100 capsules/bottle. Export: 100 capsules (10 capsules/PTP X 10).