Difsetin Capsule 20 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20 mg orally once daily in the morning. In controlled clinical trials, doses of 20～80 mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg per day should not be exceeded. Onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, but psychopharmacologists recognize that acute episodes of depression require several months or more of drug treatment. 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 60 mg of this medicine per day. The daily dose should not exceed 80 mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60 mg of this medicine per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. 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 treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 5 weeks after administration of linezolid or intravenous methylene blue, or 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 risks associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with an intravenous dose of 1 mg/kg or less of this medicine are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions; therefore, the risk and benefit should be carefully assessed by a physician when administered to patients in this age group. This drug should not be used in patients with hypersensitivity, severe renal dysfunction, or those currently taking certain types of medications, including MAO inhibitors. Caution should be exercised when administering this drug to patients with a history of seizures; treatment should be discontinued immediately if seizures worsen or new seizures occur. Patients at risk of suicide should be monitored particularly closely during treatment initiation and dosage adjustments, and both patients and caregivers should be informed to report any abnormal behavior or suicidal thoughts to a physician immediately. This drug should be used with caution in patients with a history of mania or hypomania, and the administration should be discontinued if manic symptoms appear. Patients with cardiovascular disease or those at risk of QT interval prolongation should undergo an ECG before using this drug and should be monitored closely during treatment. Patients with impaired liver or kidney function may require dose adjustments, and diabetic patients should regularly check their blood glucose control status. This drug can induce pupil dilation, so it should be used cautiously in patients at risk of increased intraocular pressure or glaucoma. During the course of taking this medication, side effects such as headaches, nausea, insomnia, fatigue, and diarrhea can commonly occur, and in case of severe allergic reactions or skin rashes, use should be discontinued immediately and a doctor should be consulted. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, or nausea, so it should be gradually reduced under the guidance of a physician. This drug may interact with other medications, so it is essential to consult a doctor when starting a new medication or stopping an existing one, especially MAO inhibitors or serotonin-affecting drugs, due to potential risks. During pregnancy, there may be risks to the fetus, so it should only be used when necessary, and breastfeeding women should consider stopping breastfeeding due to the possibility of the drug being excreted in breast milk. In pediatric and adolescent populations, safety and efficacy have not been sufficiently established, and it is advisable not to prescribe it if possible. Elderly individuals should be cautious as they may have an increased risk of side effects depending on other health conditions and medication use. In the event of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, requiring immediate medical attention; there is no specific antidote. Caution should be taken when driving or operating dangerous machinery as judgment and motor skills may be affected. It is advisable to avoid alcohol consumption, and if any worsening symptoms or unusual behaviors occur while taking this medication, consult a physician immediately.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, dissociation, elevated mood, happy mood, thought disorders, altered libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and actions, confusion, attention deficits, dizziness, taste disturbances, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic spasms, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myalgia, increased urinary frequency, dysuria, urinary retention, voiding 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 values, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremor, headache, anaphylactoid reaction, gradual systemic response, severe skin, renal, hepatic, or pulmonary related reactions, weight loss, growth retardation, hyponatremia, platelet function changes, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia

This medication should be stored in a tightly closed container protected from air and moisture, preferably at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and prevents degradation.

Appearance

A hard capsule with a green upper part and a yellowish lower part, filled with a white to grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle