Serotin Capsule 20 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride administered orally once daily in the morning. In controlled clinical trials, doses of 20～80mg daily were administered. If no improvement is observed, a dose increase 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 patients should be treated with this medicine, but psychopharmacologists recognize that acute symptoms 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 continue stability. 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. The dose may be increased or decreased 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 medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged 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 comes first. Treatment with this medicine may be restarted 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 a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric conditions, hence caution should be exercised in these age groups. It should not be administered to certain patients, for instance, those allergic to this drug or its components, those with severe renal impairment, or those currently using MAO inhibitors. Particular caution should be applied when prescribing to patients with a history of seizures or high suicidal risk, and they should consult a physician immediately if symptoms worsen or abnormal behaviors occur. Patients with heart disease or at risk of QT interval prolongation must undergo monitoring including ECG when using this medication. Patients with impaired liver or kidney function should have their dosage adjusted or use the medication with caution, and diabetic patients should carefully monitor their blood sugar levels. This medication may cause pupil dilation and should be used cautiously in patients at risk of increased intraocular pressure or acute glaucoma. During the use of this medication, various side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur; if symptoms persist or worsen, it is essential to inform medical personnel. Particularly during the early stages of treatment or when changing doses, mental symptoms such as suicidal impulses, aggression, anxiety, and restlessness should be closely monitored, and family or caregivers should pay careful attention to the patient. Abrupt discontinuation of this medication may lead to withdrawal symptoms, including dizziness, abnormal sensations, sleep disturbances, anxiety, and headaches, so discontinuation should always be gradual under a physician's guidance. Additionally, this medication may interact with other drugs, hence it's critical to discuss with a healthcare professional if you are taking or planning to take other medications. During pregnancy, potential risks to the fetus must be considered; thus, the use of this medication should only be contemplated if the benefits outweigh the risks, and careful evaluation is necessary while breastfeeding, as the drug can be transmitted through breast milk. Safety and efficacy for use in children and adolescents have not been adequately confirmed and are not recommended in these age groups. No specific adverse reactions have been reported in the elderly, but caution is required depending on other conditions or medications used. In cases of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, requiring immediate medical attention, and because there is no specific antidote, appropriate treatment must be applied according to symptoms. Keep this medication out of reach of children, and be careful not to transfer it to other containers as it may affect quality.

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, feelings of happiness, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, abnormal movements, ataxia, balance disorders, tonic-clonic seizures, spasms, inability to sit still, buccal-lingual syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, 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, pruritus, hyperhidrosis, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, 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 function tests, fracture, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, renal, liver or pulmonary-related reactions, suicidal ideation, suicidal behavior, behavior related to suicide, hostility, growth retardation, withdrawal symptoms, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, 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, akathisia, psychomotor agitation

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help ensure the medication's effectiveness.

Appearance

A hard gelatin capsule of light yellow color containing a white to light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle