Fluox Capsule 20 mg (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, an increase in dose may be considered after several weeks. Doses exceeding 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 starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, but psychopharmacologists agree that acute symptoms of depression require medication 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 continue remission. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte levels 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. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbidities: Use a low 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 Allow at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this medicine. Conversely, allow at least 5 weeks after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization, consider other interventions. 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, 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 nonintravenous routes (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 is primarily used to treat psychiatric disorders such as depression, and care must be taken especially for children, adolescents, and young adults due to the increased risk of suicidal thoughts and behavior. This medication should not be used in certain patients, such as those with allergies to this medication or its components, individuals with severe kidney dysfunction, and those taking MAO inhibitors. Particular caution should be exercised when administering this medication to patients with a history of seizures, a high risk of suicide, a history of mania, heart disease, or reduced liver or kidney function, and patients with diabetes. Common side effects during this medication include headache, nausea, insomnia, fatigue, and diarrhea, while serious side effects such as severe allergic reactions, skin rashes, bleeding, and heart arrhythmias may occur rarely; immediate consultation with healthcare personnel is required if such symptoms arise. Since this medication can interact with other drugs, it is crucial to consult a physician, especially when used in conjunction with MAO inhibitors, antidepressants, anticoagulants, or specific cardiovascular medications, and it is advisable to avoid alcohol intake. Women who are pregnant or breastfeeding should discuss with a physician before use as this medication may affect the fetus or newborn. The safety and efficacy of this medication have not been sufficiently confirmed in children and adolescents; therefore, it is not recommended. In elderly patients, caution is needed depending on other diseases or medication use. When discontinuing this medication, do not stop abruptly; doses should be gradually reduced according to a physician's instructions, as withdrawal symptoms may occur. This medication should be kept out of the reach of children, and storing it in a different container should be avoided.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, euphoric mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, abnormal movements, ataxia, balance disorders, stereotyped muscle spasms, seizures, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, indigestion, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency to bruise, diaphoresis, angioedema, petechial hemorrhage, phototoxicity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorder, gynecological bleeding, erectile dysfunction, ejaculation disorder, 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 impairment, sleep disturbances, lethargy, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver, or lung-related reactions, suicidal ideation, suicidal behavior, mania, hypomania, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, exacerbation of existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a light yellowish color, containing a white to light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle