Norjak Capsule 20mg (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, an increase in dosage 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 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 stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medicines, elderly patients, and patients with concurrent diseases: Administer a low dose or reduce the frequency of administration. Adjust the dosage 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 medicine, an interval of at least 14 days must be allowed. Conversely, at least 5 weeks must elapse after discontinuing this medicine 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 this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, use should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 medicine 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 for 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. The risk associated with non-intravenous administration (oral tablets or local injection) of methylene blue or intravenous administration of this medicine at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

This medication may increase the risk of suicidal thoughts or behavior in younger populations with major depression or other psychiatric illnesses, so it is crucial to consult with a physician adequately before administration and make a careful decision. This medication should not be used in certain patients, such as those allergic to this drug or its additives, those with severe renal impairment, and those currently taking MAO inhibitors. Patients with a history of seizures should use this medication with caution; treatment should be stopped immediately if a seizure occurs or its frequency increases. Patients at risk of suicide should be closely monitored, especially during the initial stages of treatment and when changing dosages, and families or caregivers should also observe changes in the patient's condition. Patients with a history of mania or hypomania should be cautious while using this medication, and treatment should be stopped if manic symptoms appear. Patients with heart diseases or those at risk for QT interval prolongation should have an ECG before the administration of this medication, and treatment should be stopped immediately if unusual symptoms appear. Patients with impaired liver or kidney function should have their doses adjusted, and diabetic patients should monitor their blood glucose levels as this medication may affect blood sugar control. This medication can cause pupil dilation, and patients at risk of increased intraocular pressure or acute glaucoma should be cautious. Patients with allergic reactions to certain dyes contained in this medication should use it carefully. Common side effects of this medication include headaches, nausea, insomnia, fatigue, and diarrhea; if abnormal behavior or suicidal thoughts occur, consult a doctor immediately. Suddenly stopping this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, trembling, etc., thus the dose should be gradually reduced according to a physician's instructions. Interactions with other medications may occur, so patients should inform their doctors or pharmacists of any other medications they are taking. During pregnancy, there is a potential risk to the fetus, so use under a doctor's judgment is essential, and caution is needed during lactation as this medication may secret into breast milk. Safety in children and adolescents has not been established, and this medication is not recommended for them. Elderly patients should be cautious due to the risk of adverse reactions depending on other diseases or medications they are taking. In cases of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac issues may occur, and immediate medical attention should be sought. This medication should be kept out of reach of children, and transferring it to another container is not advisable for quality maintenance.

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, feelings of happiness, thought disorder, 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, tonic-clonic seizures, spasms, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, swallowing difficulties, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency to bruising, cold sweats, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, bladder 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, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid response, progressive systemic response, severe reactions related to skin, kidneys, liver, or lungs, behavior related to suicide, hostility, growth retardation, Stevens-Johnson syndrome, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-mediated hemolytic anemia, renal failure, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C. Storing it this way helps maintain its effectiveness over a longer period.

Appearance

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

Package unit

30 capsules/bottle, 200 capsules/bottle