Rosetan Capsule (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride, administered 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 in 2 divided doses (morning and noon), and the maximum dose of 80 mg per day 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 drug; however, psychopharmacologists recognize 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 the amount needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60 mg of this drug 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 drug per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug 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 concomitant illnesses: 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 a psychiatric disorder and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this drug. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization, or other interventions, consider administration. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this drug, and no alternative to linezolid or intravenous methylene blue is available, 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this drug at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of an emergency onset of serotonin syndrome with these uses.

This medication is primarily used as an antidepressant for psychiatric disorders such as depression. When taking this medication, there is a possibility that suicidal thoughts or behaviors may increase in children, adolescents, and young adults aged 18 to 24, so physicians should carefully assess the need for treatment and the associated risks. Particularly, patients under 25 years of age may have an increased risk of suicide, so during the initial treatment phase and when the dose is changed, patients and their guardians should carefully monitor symptoms. This medication should not be administered to specific patients, for example, those who are allergic to this medication or its components, have severe kidney dysfunction, or are taking another medication called an MAO inhibitor. Patients with a history of seizures or manic symptoms should use this medication cautiously, and treatment should be immediately discontinued if seizures occur or manic symptoms appear. Patients with heart disease or those at risk of cardiac issues like QT interval prolongation also require caution, and dosage adjustments may be needed for patients with impaired liver or kidney function. Diabetic patients should monitor their blood sugar levels closely as this medication can affect blood sugar control. This medication may cause pupil dilation, so care is needed for patients with elevated intraocular pressure or those at risk for glaucoma. Common side effects during use may include headache, nausea, insomnia, fatigue, and diarrhea, and serious side effects such as allergic reactions or cardiac arrhythmias have been reported rarely. Additionally, if this medication is suddenly discontinued, symptoms such as dizziness, sensory abnormalities, anxiety, nausea, and tremor may occur; therefore, it should be tapered off gradually under a physician's supervision. This medication may interact with other drugs; if you are taking any other medications, you should consult with your physician or pharmacist, especially in the case of MAO inhibitors or serotonin-acting medications, which should not be used together. During pregnancy, it should only be used when absolutely necessary due to potential risks to the fetus, and caution is also needed while breastfeeding as this medication can be excreted in breast milk and affect the baby. It is recommended that this medication is not used in children and adolescents, as safety and efficacy have not been sufficiently established. No specific adverse reactions have been reported in the elderly; however, caution is warranted depending on the presence of other diseases or medications being taken. Finally, while taking this medication, caution should be exercised regarding activities like driving or operating machinery, and alcohol consumption is not recommended.

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, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, spasms, inability to remain seated, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT 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 to bruise easily, diaphoresis, angioedema, petechiae, phototoxicity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disorders, sleep disturbances, asthenia, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe reactions related to skin, kidneys, liver or lungs, weight loss, growth retardation, delayed puberty, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, desquamative 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, inability to remain seated, psychomotor restlessness, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding from the skin

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. A storage temperature of between 1 degree and 30 degrees Celsius is recommended.

Appearance

A hard capsule with the upper part in teal and the lower part in light yellow, filled with a white to grayish-white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle