Norzak Capsule 10mg (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 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; however, psychopharmacologists generally agree that acute episodes 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 drug per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid diseases: 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 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 requiring treatment of a more urgent 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 product. 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 product 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 product may be resumed 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 intravenous administration of this product 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 medication can increase the risk of suicidal thoughts or behaviors when administered to children, adolescents, and young adults with major depressive or psychiatric disorders. Therefore, doctors must carefully evaluate the necessity and risks. This medication should not be administered to certain patients. For instance, it is contraindicated in patients with allergies to this medication or its components, severe renal impairment, and those currently taking specific types of medications like MAO inhibitors. Special caution is required for patients with a history of seizures, suicidal tendencies, a history of mania, or those with heart disease or impaired liver and kidney function. Diabetic patients may experience difficulties in blood sugar control while taking this medication, necessitating an adjustment in the doses of insulin or other hypoglycemic agents. This medication may dilate the pupils, so caution should be exercised in patients with elevated intraocular pressure or at risk for acute glaucoma. Common side effects during the use of this medication include headaches, nausea, insomnia, fatigue, diarrhea, etc., while rare but serious side effects include severe allergic reactions, bleeding, cardiac arrhythmias, and liver dysfunction. Especially in children and adolescents, there is a risk of suicidal thoughts and behaviors, growth delays, and sexual development disorders, so its use is not recommended. This medication can cause withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors if discontinued abruptly after long-term use, so doses should be tapered gradually under physician guidance. This medication can interact with other drugs, especially MAO inhibitors, other antidepressants, anticoagulant medications, and heart-related drugs; therefore, it is essential to consult a physician if any of these medications are being taken. The risks and benefits for the fetus must be carefully considered when used during pregnancy, and in breastfeeding, there is a possibility of drug transmission through breast milk, so discontinuation of breastfeeding should be considered. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, and caution is needed for the elderly depending on their other conditions or medications. In the case of an overdose, symptoms such as nausea, vomiting, seizures, cardiac arrhythmias, and coma may occur, necessitating immediate medical attention; there is no specific antidote. This medication should be kept out of the reach of children and should not be transferred to other containers to maintain quality. Judgment and motor functions may be affected during treatment, so care should be taken while driving or operating dangerous machinery, and alcohol consumption should be avoided.

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, sexual desire disorder, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorders, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic clonic seizures, convulsions, akathisia, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechial hemorrhage, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, urinary frequency, dysuria, urinary retention, voiding dysfunction, 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 disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behavior, 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, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication should be stored in a tightly sealed container to prevent air and moisture ingress, preferably at room temperature between 1°C and 30°C. Such storage conditions will help maintain the medication's effectiveness and prevent degradation.

Appearance

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

Package unit

30 capsules/bottle, 200 capsules/bottle