Pulsitin Capsule (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, a dose increase 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 must not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks or longer of treatment. 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 that needed to maintain or continue stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine 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 comorbidities: Administer a low 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 must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 must 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, other interventions 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 judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. The patient 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 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 medicine at 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 is primarily used to treat psychiatric disorders such as depression, and there is an increased risk of suicidal impulses or behavior, particularly in children, adolescents, and young adults, so careful monitoring is required. This medication should not be used in patients with hypersensitivity, severe renal dysfunction, or those taking certain types of medications such as MAO inhibitors. Particular caution should be exercised in administering this medication to patients with a history of seizures or suicidal tendencies as well as those with heart disease or liver and kidney function issues. Common side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur during treatment, and there is a rare risk of serious allergic reactions, bleeding, and cardiac arrhythmias. Changes in mental state such as suicidal impulses or behavior, aggression, and anxiety should be closely monitored when starting treatment or adjusting dosages, and family members or caregivers should be instructed to observe the patient carefully. Women who are pregnant or breastfeeding should carefully consider the use of this medication due to potential effects on the fetus or newborn. This medication may interact with other drugs, therefore, any concurrent or planned use of other medications should be discussed with a doctor. When discontinuing, do not stop abruptly; taper the dosage gradually according to a physician's instructions, as sudden discontinuation may result in withdrawal symptoms such as dizziness, anxiety, and headaches. Furthermore, this medication has not been adequately evaluated for safety and efficacy in children and adolescents, and its use is not recommended in these populations. Care should be taken when driving or operating hazardous machinery during treatment, and alcohol ingestion should be avoided. Finally, this medication should be stored out of the reach of children, and should not be transferred to other containers to ensure safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, 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, tonic-clonic muscle spasms, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, sweating, increased tendency for bruising, cold sweat, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, muscle spasms, myalgia, frequent urination, dysuria, urinary retention, urinary 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, fractures, dizziness, sensory disturbances, sleep disorders, myasthenia, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe reactions related to the skin, kidneys, liver, or lungs, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, 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

This medication can be sensitive to air or moisture, so it should be kept in a tightly closed container. It is best to store it at room temperature between 1°C and 30°C. Doing so will help maintain the efficacy of the medication over time.

Appearance

A hard capsule with a green upper part and a light yellow lower part filled with white to grayish-white powder

Package unit

30 capsules/bottle, 100 capsules/bottle