Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dosage 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 dosage 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 a sufficient 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 continue stability. 2. Bulimia nervosa Administer 60mg per day of this medicine. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg per day of this medicine. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day of this medicine. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dosage 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, 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 be started on this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for 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 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 medicine may be discontinued 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 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 with 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. The risk of suicidal thoughts or behavior may be increased, particularly in children, adolescents, and young adults; therefore, careful monitoring is required. This medication should not be administered to certain patients, such as those with allergies to the drug or its excipients, severe renal impairment, or those taking MAO inhibitors. Particular caution should be taken with patients having a history of seizures, high suicide risk, history of mania, heart disease, etc., and dosage adjustments may be necessary for patients with impaired liver or kidney function. For diabetic patients, it may affect blood glucose control, so they should frequently check blood glucose levels and may need to adjust insulin or hypoglycemic agent doses. Common side effects include headache, nausea, insomnia, fatigue, diarrhea, while rare but serious side effects may include allergic reactions, liver function abnormalities, bleeding, and cardiac arrhythmias. Upon discontinuation, withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, tremors may occur, making it important to gradually taper the dosage. This medication may interact with other drugs, so patients taking or planning to take other medications should consult their doctor or pharmacist, especially avoiding co-administration with MAO inhibitors due to potential risks. During pregnancy, use should be limited only to necessary cases due to risks to the fetus, and in nursing mothers, consideration should be given to discontinuing breastfeeding as the drug can be excreted in breast milk. Safety and efficacy in children and adolescents have not been established, and use in this age group is not recommended. No specific adverse reactions have been reported in elderly patients, but caution is advised based on other diseases or medication circumstances. In cases of overdose, symptoms such as nausea, vomiting, seizures, cardiac arrhythmias, coma may occur, requiring immediate medical attention; there is no specific antidote, so treatment should be symptomatic. This medication should be stored out of the reach of children, and transferring it to other containers is not advisable for quality maintenance.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, neuroticism, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, derealization, elevated mood, happy mood, thought disorder, 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, cramps, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, sweating, angioedema, petechiae, photophobia, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, urinary 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, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, gradual systemic response, severe skin, kidney, liver or pulmonary-related reactions, weight loss, growth delay, hyponatremia, changes in platelet function, 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-related hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius. This will help to preserve the effectiveness of the medication.

Appearance

A solid green capsule filled with white to off-white powder.

Package unit

30 capsules/bottle, 200 capsules/bottle