Isetin Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg 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 the 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 a full 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 a patient should be treated with this medicine, but psychopharmacologists agree 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 remission. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medicines, elderly patients, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to MAO inhibitors used to treat psychiatric disorders When stopping an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must elapse. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must elapse after discontinuing this medicine. 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 of a psychiatric condition, including hospitalization or 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 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 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 receiving linezolid or intravenous methylene blue, or for 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 administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine 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 drug is an antidepressant used for psychiatric disorders such as major depressive disorder. During the intake of this drug, the risk of increased suicidal impulses or behaviors may arise; hence, young patients, especially those between the ages of 18 and 24, should be monitored more closely. It is not recommended for use in children and adolescents as safety and efficacy have not been established. Avoid use in patients with an allergy to this drug, severely impaired renal function, or those taking certain types of medications (MAO inhibitors). Patients with a history of seizures should be cautious as the risk of seizures may increase during the use of this drug, and care is also needed for those with heart conditions or abnormal electrocardiograms. Diabetic patients may experience impacts on blood sugar control, and blood sugar should be checked regularly with adjustments made to medication dosage as necessary. This drug can occasionally cause severe allergic reactions, skin rashes, bleeding, or liver function abnormalities; patients should consult a doctor immediately if symptoms occur. Avoid alcohol consumption during treatment, and consult with a doctor or pharmacist when taking this medication in conjunction with others. Women who are pregnant or nursing should consult extensively with a doctor as this drug may affect the fetus or baby. Abrupt cessation of this drug may cause withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; dosage should be gradually reduced according to a doctor's instructions. Caution should be exercised when performing activities that require attention, such as driving or operating machinery while taking this drug. It is important to consult healthcare professionals immediately if there are any changes in mental state or behavior during treatment.

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, elevated mood, happy mood, abnormal thoughts, abnormal libido, teeth grinding, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, dystonic muscle spasms, cramps, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, increased tendency for bruising, cold sweat, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, micturition disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, 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 disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, suicidal ideation, suicidal behavior, 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, kidney failure, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, seizures, asymptomatic arrhythmias, cardiac arrest, coma

This drug may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to maintain the drug's efficacy and safety.

Appearance

A capsule with green upper and lower parts filled with white or grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle