Proctin Capsule 20mg (Fluoxetine Hydrochloride)

Adult dosage

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 per day were administered. If no improvement is observed, an increase in the 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 an adequate antidepressant effect may be delayed until 4 weeks or longer after the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this product; 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 required to relieve symptoms is the same as that required to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this product per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this product per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this product per day. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: 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 starting treatment with this product, 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 product. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this product because of the increased risk of serotonin syndrome. For patients who require 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 product. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this product 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 product may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or intravenous administration of this product at a dose of 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 associated with depression. It is not approved for use in children or adolescents, and there may be an increased risk of suicidal thoughts or behavior in young adults aged 18 to 24, so caution is advised. During treatment with this medication, changes in mental states such as suicidal tendencies, aggression, anxiety, and insomnia should be closely monitored. Patients with hypersensitivity or severe renal impairment, as well as those taking specific medications such as MAO inhibitors, should not use this medication. Patients with a history of seizures should use this medication cautiously, and treatment must be discontinued immediately if seizures occur or frequency increases. Patients with heart disease or those at risk for QT interval prolongation should have an ECG before administration and discontinue if any abnormalities arise. Patients with impaired liver or kidney function may need dosage adjustments. Diabetic patients should closely monitor their blood glucose levels as it may change during treatment. This medication may cause pupil dilation, so caution is required for patients with glaucoma. Common side effects include headache, nausea, insomnia, fatigue, and diarrhea; if allergic reactions or severe skin rashes occur, consult a doctor immediately. Sudden discontinuation of this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, and anxiety; therefore, it is recommended to gradually taper off the dosage. During pregnancy, the risks and benefits to the fetus must be carefully considered, and caution is advised during breastfeeding as the drug may be passed into breast milk. Interactions may occur when taken with other medications, so any other medicines being taken should be discussed with a doctor or pharmacist. This medication may affect judgment or motor skills, so caution is needed when driving or operating hazardous machinery. In case of overdose, cardiac problems or central nervous system symptoms may occur, requiring immediate medical attention. This medication should be kept out of reach of children, and it is advisable not to change the container arbitrarily.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis reactions, serum sickness, inappropriate secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, sexual desire abnormalities, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disorders, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, spasms, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory disorders, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, muscle spasms, myalgia, frequent urination, dysuria, urinary retention, voiding 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, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, gradual systemic reactions, severe skin, kidney, liver or lung-related reactions, suicidal ideation, suicidal behavior, increased suicidal tendency, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, aggressive behavior, 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, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, vaginal bleeding

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help maintain the drug's effectiveness and safety.

Appearance

A hard capsule with a green upper part and a white lower part filled with white to off-white powder.

Package unit

For domestic use - 30 capsules/bottle, for domestic use - 200 capsules/bottle