Rosetin Capsule (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 twice daily (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; however, it is generally accepted among psychopharmacologists 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 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, 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 psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks should have elapsed 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, consider administering treatment. 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, for a specific 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 comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks 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, are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

This medication is primarily used to treat psychiatric disorders such as depression. It may increase the risk of suicidal thoughts or behaviors in young patients, especially those aged 18 to 24, thus caution should be exercised when administering to this age group. This medication should not be used in patients with hypersensitivity to it or those with severe renal impairment, as well as in patients taking certain types of medications (MAO inhibitors). Patients with a history of seizures need to be particularly careful when using this medication, and treatment should be halted immediately if seizures occur or if their frequency increases. Patients with depression or those at high risk of suicide may experience worsening of their condition in the early stages of treatment; therefore, careful observation and monitoring are required. Patients with heart disease or problems related to QT interval prolongation should undergo an ECG prior to using this medication and periodically monitor their cardiac status during treatment. Patients with impaired liver or kidney function should have their doses reduced or be administered cautiously. Diabetic patients may experience changes in blood sugar control while on this medication, and blood glucose levels should be monitored frequently, adjusting medication doses as necessary. This medication may dilate pupils, so caution is required for patients with elevated intraocular pressure or those at risk for glaucoma. Common side effects during treatment may include headaches, nausea, insomnia, fatigue, and diarrhea; should severe allergic reactions or skin rashes occur, medical consultation should be sought immediately. Suddenly discontinuing this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors, so doses should be tapered down gradually following a physician's directions. Interactions with other medications are possible; therefore, inform the physician or pharmacist of any other medications being taken. Pregnant or nursing women should consult with healthcare professionals as the use of this medication may affect the fetus or newborn. Safety and efficacy in children and adolescents has not been established, so use should be avoided if possible. Elderly patients may have increased risk of side effects depending on concurrent medical conditions or medications, thus care is needed. This medication may impair judgment or motor skills when driving or operating dangerous machinery, so caution is advised. Alcohol consumption may affect the efficacy or side effects of this medication and is therefore not recommended. Store out of the reach of children and do not transfer to another container.

headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal hormone secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, myotonic contractions, seizures, inability to remain seated, 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, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency to bruise easily, cold sweat, angioedema, petechial hemorrhage, photosensitivity, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, voiding dysfunction, 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, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, suicide-related behaviors, hostility, growth delay, decreased alkaline phosphatase levels, changes in platelet function, 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, necrosis, 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

Store this medication in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Hard capsule with a green upper part and a light yellow lower part, filled with white or grayish-white powder

Package unit

30 capsules/bottle, 200 capsules/bottle