Serosetin Capsule 20mg (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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (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 patients should be treated with this medicine; however, 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 stability. 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 the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant illnesses: 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 initiating treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when initiating an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must 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 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 no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine at doses 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 medication is primarily used to treat psychiatric disorders such as depression. It may increase the risk of suicidal ideation or behavior in children, adolescents, and young adults aged 18 to 24. Therefore, when administering to this age group, careful evaluation of the risks and benefits by a healthcare professional is required. This medication should not be administered to specific patients, such as those with allergies to this drug or its additives, severe renal impairment, and patients currently taking certain other medications (MAO inhibitors). Particular caution is required for patients with a history of seizures or high suicide risk, those with a history of mania, and patients with cardiac disease or liver and kidney dysfunction. Since this drug is metabolized in the liver and excreted by the kidneys, dose adjustment may be needed for patients with liver or kidney impairment. In diabetic patients, changes in blood glucose control may occur while taking this medication, so blood glucose should be closely monitored. This medication may dilate the pupils, so caution is advised in patients with high intraocular pressure or a risk of glaucoma. Additionally, this drug contains a specific dye (Yellow No. 5), so patients allergic to this dye should be cautious. Side effects such as headaches, nausea, insomnia, fatigue, diarrhea, etc., may occur while taking this medication, and if symptoms are severe, consultation with a healthcare professional is necessary. In the early stages of treatment or when changing doses, abnormal behavioral changes such as suicidal thoughts, aggression, anxiety, and restlessness may occur, so patients and caregivers should observe closely. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors, so the dosage should be reduced gradually as directed by a physician. Caution is necessary for concomitant use of this medication with other serotonin-acting drugs, as this may lead to serious serotonin syndrome. Alcohol consumption is not recommended, and caution is needed when driving or operating dangerous machinery. During pregnancy, it should only be used if absolutely necessary due to potential risks to the fetus, and during breastfeeding, careful consideration should be given as this drug may be excreted in breast milk and affect the baby. Elderly patients need to be cautious as they may have a higher risk of side effects depending on other comorbidities or medications. In case of overdose, serious symptoms such as nausea, vomiting, seizures, and heart arrhythmias may occur, and immediate medical attention should be sought. This medication should be stored out of the reach of children and should not be transferred to other containers for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, disorders of libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, dysgeusia, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, spasms, sitting disability, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, 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, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, 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, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, suicidal ideation, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, erythema nodosum, 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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness safely.

Appearance

A hard capsule containing white to light gray powder with a light yellow upper and lower part.

Package unit

30 capsules/bottle, 100 capsules/bottle