Profin Capsule (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 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 twice daily (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 of treatment or longer. 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 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 sustain stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. Reassess whether continued treatment is needed after 6 months of treatment. 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 dosing frequency. 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 start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization and other interventional procedures, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient who is already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue 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 drug may be stopped 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 administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with an intravenous dose of this drug 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 behaviors in children and adolescents with major depressive disorder or psychiatric disorders, as well as in young adults aged 18 to 24, when used for a short term, so physicians should carefully consider the need for treatment and the associated risks. This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to this medication or its additives, in patients with severe renal impairment, or in patients currently taking MAO inhibitors. Caution should be exercised in administering this medication to patients with a history of seizures, those at high risk of suicide, patients with a history of mania, patients with heart disease, or those with liver and kidney function problems, diabetics, and patients at risk of increased intraocular pressure. Common side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur during the use of this medication, and rarely, allergic reactions, bleeding, weight loss, withdrawal symptoms, etc., may happen, so caution is necessary. During the initial administration or dose adjustment, careful observation for changes in mental state such as suicidal thoughts, behavioral changes, aggression, and anxiety is required, and the patient and caregiver should consult a physician immediately if such symptoms appear. This medication may interact with other drugs, so it is essential to consult a physician before taking it together with MAO inhibitors, serotonergic agents, anticoagulants, antidepressants, etc., and it is advisable to avoid alcohol consumption. During pregnancy, the risks to the fetus and the benefits of this medication must be carefully considered, and caution is necessary during breastfeeding as the medication may be passed through breast milk. The safety and efficacy in children and adolescents have not been established, so the use of this medication is not recommended. No specific adverse reactions have been reported in the elderly, but caution is needed depending on other medical conditions or medications they may be taking. In cases of overdose, serious symptoms may appear, including nausea, vomiting, seizures, and cardiac irregularities, so one should seek appropriate care immediately, and the discontinuation of this medication should be done gradually per a physician's instruction. This medication should be stored out of reach of children and should not be transferred to other containers.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorder, sexual desire disorder, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorder, somnolence, drowsiness, tremors, psychomotor agitation, movement disorder, ataxia, balance disorder, tonic-clonic convulsions, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity, 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, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe reactions related to the skin, kidneys, liver, or lungs, suicide-related behaviors, hostility, growth retardation, decreased alkaline phosphatase levels, platelet function changes, abnormal bleeding, 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, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, psychomotor restlessness

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to ensure the medication's effectiveness.

Appearance

Hard capsule filled with white to grayish powder, upper part green, lower part pale yellow

Package unit

30 capsules/bottle, 200 capsules/bottle