Kukje Fluoxetine Capsule (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: Administer fluoxetine hydrochloride 20mg orally once daily in the morning as the initial dose. Doses of 20～80mg per day were administered in controlled clinical trials. If no improvement is observed, an increase in dose 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 medicine; however, psychopharmacologists recognize 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 that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this medicine per day. Do not exceed a daily dose of 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. Do not exceed a daily dose of 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 medications, elderly patients, and patients with concomitant diseases: Administer 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 psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, if starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must elapse after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider treatment. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue, and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. 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 comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection), or intravenous administration of this medicine at 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 is primarily used as an antidepressant for treating psychiatric disorders. During the course of treatment with this medication, there may be an increase in suicidal impulses or behaviors, so young patients, particularly those aged between 18 and 24, should be monitored closely. Patients with a history of allergic reactions to this medication, severe kidney impairment, or those taking certain types of medications (e.g., MAO inhibitors) should not take this medication. Patients with a history of seizures or suicidal tendencies should use this medication with caution, and they should promptly consult a physician if their symptoms worsen or if abnormal behaviors arise. Patients with heart disease or liver or kidney function issues should exercise extreme caution when using this medication. Diabetic patients should closely monitor their blood glucose levels as changes may occur during treatment with this medication. This medication can cause pupil dilation, so patients at risk for increased intraocular pressure should be cautious. Common side effects that may occur during treatment include headaches, nausea, insomnia, fatigue, and diarrhea, and patients should inform their doctor if these effects become severe. Abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so dosages should be gradually reduced under a physician's guidance. This medication can interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking, and it is advised to avoid alcohol consumption. Pregnant or breastfeeding women should consult their physician before taking this medication, as it may affect the fetus or newborn, necessitating careful consideration. Safety for children and adolescents has not been established, and it is recommended not to administer this medication to them. Elderly patients must be cautious as the risk of side effects may increase depending on other conditions or medications being taken. In cases of overdose, symptoms may include nausea, vomiting, seizures, and cardiac arrhythmias, requiring immediate medical attention.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, benign fasciculation syndrome, seizures, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, incidents related to the lungs, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increase in tendency to bruise, sweating, angioedema, petechiae, photosensitivity reactions, 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, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, suicidal ideation, suicidal behavior, 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, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication may be sensitive to air or humidity, so it is important to store it in a tightly sealed container at room temperature. Room temperature is generally defined as between 15 and 25 degrees Celsius, and extremes in temperature should be avoided.

Appearance

Green hard capsule with a yellowish base filled with a white to whitish powder

Package unit

30 capsules/bottle, 100 capsules/bottle