UniZac 10mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20～80mg daily were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses greater than 20mg daily should be administered twice daily (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 or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists agree 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 remission. 2. Bulimia nervosa Administer 60mg daily of this drug. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg daily of this drug. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg daily of this drug. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, and patients with concomitant diseases: Use a lower dose or reduce the frequency of administration. 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, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat a psychiatric disorder. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventions, consider administering treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug may be discontinued 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 methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this drug 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 drug is an antidepressant used for treating psychiatric disorders such as depression and may increase the risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults; therefore, careful monitoring is essential. This drug should not be administered to certain patients, such as those allergic to this drug or its additives, those with severe renal impairment, or those taking MAO inhibitors. Patients with a history of seizures or high risk of suicide, patients with a history of mania, patients with heart diseases, patients with impaired liver or kidney function, and diabetic patients should be particularly cautious when using this drug, and changes in symptoms should be closely monitored during treatment. Common side effects when taking this drug include headaches, nausea, insomnia, fatigue, diarrhea, and rare but serious allergic reactions, cardiac arrhythmias, bleeding, and hepatitis may occur. When discontinuing the prescription, it should not be stopped abruptly but rather gradually reduced in dosage, as withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea may occur, necessitating caution. Also, this drug may interact with other medications, so it is essential to consult a physician if you are currently taking or planning to take other drugs, especially if combining with MAO inhibitors or serotonergic drugs, which may be dangerous. Pregnant or breastfeeding women should thoroughly consult with a physician regarding the use of this drug, as it may affect the fetus or newborn; thus, caution should be exercised. This drug is not recommended for children and adolescents, as safety and efficacy have not been established, and should be used cautiously in the elderly. In case of overdose, serious side effects may occur, necessitating immediate medical attention. It should be stored out of reach of children, and it is advisable not to transfer it to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, 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 disturbances, abnormal libido, teeth grinding, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, akathisia, seizures, inability to sit still, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, hives, itching, hyperhidrosis, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myasthenia, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, 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 reactions, progressive systemic reactions, severe skin, kidney, liver or lung-related reactions, suicidal ideation, suicidal behaviors, bleeding, petechiae, purpura, 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, movement disorders, exacerbation of existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This drug is sensitive to light, so it should be stored in a dark container that prevents light exposure. Additionally, it is important to store it in a cool place below 25 degrees Celsius to ensure safe storage.

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle