Rosettin Capsule 10 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 of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long a patient should be treated with this drug, but psychopharmacologists recognize 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 drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower 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 When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this drug 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 this drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for a psychiatric condition, including hospitalization, other interventional procedures should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there are no alternative medicines to linezolid or intravenous methylene blue 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with nonintravenous administration (oral tablets or local injection) of methylene blue or intravenous administration of this drug at 1mg/kg or less are 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. However, when administered to children, adolescents, or young adults, there may be an increased risk of suicidal thoughts or behavior; therefore, it should be used cautiously, especially in patients aged 18 to 24. Abnormal changes in behavior such as suicidal tendencies, aggression, or anger should be carefully monitored during treatment, and family members or guardians should also closely observe the patient. This medication should not be administered to certain patients. For example, it can be dangerous for those who are allergic to this medication or its additives, have severe renal impairment, or are taking other medications such as MAO inhibitors. Additionally, patients with genetic issues such as galactose intolerance should avoid taking it. Patients with a history of seizures should be cautious when using this medication, and if seizures occur or increase in frequency, treatment should be discontinued immediately. Patients at risk of suicide also require careful monitoring, as do patients with a history of mania or hypomania. Patients with heart disease or decreased liver or renal function should consult a physician before administration to adjust the appropriate dosage. Diabetic patients may be affected in blood sugar control and should periodically check their blood sugar status. This medication can rarely cause side effects like headache, nausea, insomnia, fatigue, and diarrhea, and in severe cases, dangerous symptoms such as allergic reactions, bleeding, or cardiac arrhythmias may occur. Withdrawal symptoms may also occur; therefore, do not abruptly discontinue use without following a physician's instructions to taper off the dosage gradually. This medication may interact with other drugs, so it is essential to consult a physician or pharmacist if other medications are being taken or if alcohol is consumed. Pregnant or breastfeeding women should carefully consider whether to take this medication based on its potential effects on the fetus or newborn, and if necessary, breastfeeding may need to be discontinued. Finally, the safety and efficacy of this medication have not been established for children and adolescents, and it is generally not recommended. Elderly patients also need to exercise caution depending on other conditions or medications. This medication should be stored out of reach of children and should not be transferred to other containers.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, inappropriate secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, spasms, akathisia, Buccoglossal syndrome, serotonin syndrome, memory disturbances, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT interval prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency for increased bruising, sweating, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequency of urination, dysuria, urinary retention, urination 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 enzyme levels, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver, or pulmonary associated reactions, growth retardation, death, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, worsening of pre-existing 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 to protect it from air and moisture. It is also advisable to store the medication at room temperature, which is neither too hot nor too cold, ideally between 1 degree and 30 degrees Celsius.

Appearance

Green capsule filled with white or grayish-white powder

Package unit

30 capsules/bottle, 200 capsules/bottle