Youngjin Fluoxetine Capsule 20mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride once daily, administered orally 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 should 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 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 stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients receiving multiple medicines, elderly patients, and patients with comorbid conditions: Administer a low 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 psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks must have elapsed 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. If a patient requires more urgent treatment for a psychiatric condition requiring other interventions, including hospitalization, consider treatment. If a patient already receiving this medicine needs urgent treatment with linezolid or intravenous methylene blue, and there are no alternatives 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 in a particular patient, this medicine 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 medicine may be resumed 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 doses of this medicine 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 may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, physicians must carefully evaluate the risks and benefits before prescribing to patients in this age group. This medication should not be given to patients with hypersensitivity, severe kidney impairment, or those taking MAO inhibitors. Patients with a history of seizures should use this medication cautiously, and if seizures occur or become more frequent, treatment should be discontinued. Patients at risk for suicide should be carefully monitored during the early stages of treatment and when changing doses, and family members or caregivers should closely observe the patient's condition. Patients with cardiovascular disease or those at risk for QT interval prolongation should have an electrocardiogram before administration, and treatment should be immediately stopped if any abnormal symptoms arise during administration. Patients with liver or kidney impairment may need dosage adjustments or careful use of this medication. Diabetic patients may require adjustments to their insulin or blood sugar medications as blood sugar control may change. Patients at risk of increased intraocular pressure or glaucoma should be cautious as this medication may cause pupil dilation. Various side effects, such as headaches, nausea, insomnia, fatigue, and diarrhea, may occur; if serious allergic reactions or skin rashes develop, treatment should be stopped immediately. Discontinuation of treatment may result in withdrawal symptoms; therefore, dosage should be gradually reduced according to the physician's instructions. This medication may interact with other drugs, so patients must inform their physicians or pharmacists about any other medications they are taking, especially MAO inhibitors, as concurrent use is contraindicated. During pregnancy, it should only be used when absolutely necessary considering the risks to the fetus, and breastfeeding should be discontinued or the minimum dosage used while nursing. It is advisable not to administer this medication to children and adolescents as safety and efficacy have not been established. Elderly patients require caution due to risks of side effects from comorbidities or drug interactions. In cases of overdose, severe symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may arise, requiring immediate medical attention. This medication should be stored out of the reach of children and should not be transferred to other containers for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, reduced libido, sleep disorder, 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 disturbance, hypersomnia, drowsiness, tremor, psychomotor agitation, abnormal movement, ataxia, balance disorder, convulsions, spasms, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, respiratory distress, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, increased tendency to bruising, cold sweats, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, joint pain, muscle cramps, myalgia, frequent urination, dysuria, urinary retention, micturition disorder, 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, fractures, dizziness, sensory disturbances, sleep disorder, asthenia, agitation, anxiety, tremor, headache, rash, anaphylactoid reaction, progressive systemic reaction, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, aplastic anemia, atrial fibrillation, cataracts, 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 disorder, exacerbation of pre-existing 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 tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps preserve the medication's efficacy and allows for safe usage.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle