Fluoxetine Capsule (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, a dose increase may be considered after several weeks. Doses exceeding 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of a sufficient antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/long-term treatment: There are no definitive data on how long a patient should be treated with this medicine, but psychopharmacologists generally agree that acute signs 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. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. The daily dose should not exceed 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 medications, elderly 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 a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. 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 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 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, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 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 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 is an antidepressant used to treat psychiatric disorders such as major depressive disorder. When administering to children, adolescents, and young adults, the risk of suicidal thoughts or behavior may increase; therefore, physicians must carefully assess treatment decisions. This medication should not be given to certain patients, such as those with allergies to this drug or its excipients, those with severe renal disease, and those currently taking MAO inhibitors. Patients with a history of seizures need to be cautious while using this drug, and treatment should be discontinued if seizures occur or worsen. Patients at risk for suicide require closer monitoring at the beginning of treatment and with dose changes, and both patients and their families should carefully observe any changes in suicidal thoughts or behavior. Caution is required when administering this medication to patients with a history of manic or hypomanic episodes, and treatment should be ceased if manic symptoms emerge. Patients with heart disease or at risk for QT interval prolongation should undergo ECG testing, and if arrhythmia symptoms occur during treatment, it should be discontinued immediately. Patients with impaired liver or kidney function should have their dosing reduced accordingly. Diabetics may experience changes in blood glucose control while taking this medication, so regular monitoring and treatment adjustments may be necessary. This medication may cause pupil dilation in patients at risk for increased intraocular pressure or acute glaucoma, and caution is advised. This drug contains Yellow No. 5, and those with sensitivity to this ingredient should be administered with caution. Common side effects of this medication may include headache, nausea, insomnia, fatigue, and diarrhea, and in rare cases, serious allergic reactions, hepatitis, or skin rashes can occur. Abrupt cessation of this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, tremors, thus dosage should be gradually tapered. Using this medication in combination with other serotonergic agents can lead to the serious side effect known as serotonin syndrome, hence special caution is needed. Alcohol consumption is not recommended, and any concurrent use of other drugs that may interact with this medication should be discussed with a physician. During pregnancy, this medication should only be used if deemed essential, and if breastfeeding, consideration should be given to the potential for drug transfer through breast milk. Elderly patients must be cautious due to potential adverse reactions depending on other comorbidities or medications. In cases of overdose, serious symptoms such as nausea, vomiting, seizures, arrhythmias, and coma may arise; thus, immediate medical attention is required. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, abnormal thoughts, 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-clonic seizures, convulsions, akathisia, Buccoglosal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary incontinence, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, restless mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremor, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver or pulmonary reactions, behaviors associated with suicide, hostility, growth delay, decreased alkaline phosphatase levels, platelet function changes, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, hyperprolactinemia, hypoglycemia, immune-related 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, hemorrhage, petechiae, purpura, abnormal bleeding from the skin

This medication may be sensitive to air or moisture and must be stored in a tightly sealed container. Additionally, it should be kept at room temperature, ideally between 1 and 30 degrees Celsius, to ensure safety and efficacy.

Appearance

A hard capsule containing a white to light gray powder with a pale yellow body and cap.

Package unit

30 capsules/bottle, 100 capsules/bottle