Unizac Capsule 20 mg (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 dose 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 must not be exceeded. 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 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 sustain remission. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose must not exceed 80mg. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for treatment of a psychiatric disorder, at least 5 weeks must have elapsed since discontinuation of this medicine. 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. When this medicine is administered intravenously at a dose of 1mg/kg or less

This medication is used to treat psychiatric disorders such as major depressive disorder and needs careful observation because there is an increased risk of suicidal thoughts or behaviors, especially in children, adolescents, and young adults aged 18 to 24. This medication should not be used in certain patients, for example, those who are allergic to this medication or its additives, those with severe renal impairment, and patients currently taking MAO inhibitors. Patients with a history of seizures should use this medication with caution and should discontinue treatment immediately if seizures occur or their frequency increases. This medication can affect the cardiovascular system; therefore, patients with heart disease or those at risk for QT interval prolongation should undergo an ECG test before administration and monitor their heart condition carefully during the treatment. For patients with decreased liver or kidney function, dosage adjustments may be necessary as the metabolism of this medication might be affected. In diabetic patients, blood sugar control may vary, so blood glucose levels should be monitored regularly, adjusting the dosage of insulin or hypoglycemic agents as needed. Patients with elevated intraocular pressure or acute glaucoma risk should exercise caution due to potential pupil dilation. Common side effects during this medication include headache, nausea, insomnia, fatigue, and diarrhea, while rare cases may present allergic reactions or serious skin reactions. In the initial phase of treatment or upon changing the dose, abnormal behavioral changes such as suicidal thoughts, aggression, anxiety, and restlessness may occur, and both patients and guardians should carefully observe these symptoms and consult a doctor immediately if any abnormal symptoms appear. There is a risk of a serious side effect known as serotonin syndrome when this medication is combined with other serotonin-acting medications, so it must be taken exactly as directed by a physician. During pregnancy, there may be potential risks to the fetus, so it should only be used when absolutely necessary, and if breastfeeding, the cessation of breastfeeding should be considered as the drug may be secreted in breast milk. The safety and efficacy of this medication have not been established in children and adolescents, so it is not recommended for use in this population. Elderly patients may require dosage adjustments, and they should inform their physician of any medications they are currently taking due to the potential for drug interactions. When discontinuing this medication, do not stop abruptly; instead, gradually reduce the dosage. Withdrawal symptoms such as dizziness, anxiety, and headaches may appear, so caution is required. It is advisable to avoid alcohol consumption while taking this medication, and care should be taken when driving or operating dangerous machinery. Store out of reach of children and do not transfer to another container for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, 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, somnolence, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, convulsions, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency to bruise, cold sweat, angioedema, purpura, phototoxic reaction, livedo reticularis, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremor, headache, anaphylactoid reaction, progressive systemic reactions, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, QT prolongation, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius to safely maintain the efficacy of the medication.

Appearance

A hard capsule with a green upper part and a yellowish lower part filled with a white powder.

Package unit

30 capsules/bottle, 500 capsules/bottle