Viewing nowFloxen Capsule (Fluoxetine Hydrochloride)
Fluoxetine Hydrochloride 22.4mg
Hard capsule · Prescription medication
Hwaile Pharmaceuticals Co., Ltd.

MFDS item code 201805198 · Approved 2018.12.20
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder
This medication is effectively used for various psychiatric conditions such as depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. In depression, this medication shows symptom improvement within 5-6 weeks and helps alleviate various symptoms such as changes in appetite and sleep, and fatigue. In patients with bulimia nervosa, it contributes to a reduction in binge eating and laxative use. In obsessive-compulsive disorder, it significantly reduces obsessive thoughts and behaviors, positively impacting social life and work performance. For patients with premenstrual dysphoric disorder, it improves cyclical depression and anxiety symptoms, as well as physical discomfort such as breast pain and headaches. However, with long-term use, the effect needs to be regularly evaluated on a per-patient basis. For these reasons, this medication is used for the treatment of various mental health issues.
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 dose 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 more of 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 several months or more of drug treatment. 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 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. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: Use a lower dose or reduce the dosing frequency. Adjust the dose appropriately 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 elapse after discontinuing this medicine. 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 more urgent treatment of a psychiatric condition that requires hospitalization or other interventions, treatment should be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks of administering methylene blue by a nonintravenous route (oral tablets or local injection), or administering this medicine by intravenous injection at a dose of 1mg/kg or less, are 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 to improve symptoms associated with depression. While taking this medication, especially in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors which should be closely monitored. Patients who have previously shown allergic reactions to this medication or its components, or those with severe renal impairment, should not use this medication. Additionally, this medication must not be used in conjunction with certain medications known as MAO inhibitors, as dangerous side effects may occur. Caution is required when administering this medication to patients with a history of seizures, and if seizures occur or increase in frequency, immediate discontinuation of use is necessary. Patients with cardiovascular diseases or at risk for cardiac rhythm disorders should also be careful when taking this medication. Patients with liver or kidney impairment may need dosage adjustment. Patients with diabetes may affect blood glucose control, so blood glucose levels need to be monitored regularly. This medication may cause side effects such as headaches, nausea, insomnia, fatigue, diarrhea, and decreased appetite in some patients. If changes in mood, anxiety, agitation, aggression, or suicidal impulses occur during treatment, consult a doctor immediately. This medication should be used cautiously during pregnancy after carefully weighing the risks versus benefits for the fetus, and consultation is required in the case of breastfeeding. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disorders, so the dosage should be gradually reduced according to a doctor's instructions. It is advisable to avoid alcohol consumption during treatment, and interactions with other medications may occur, hence consultation with a doctor or pharmacist is necessary. This medication is not recommended for use in children or adolescents as its safety and efficacy have not been adequately established. Elderly patients may have an increased risk of side effects depending on other underlying conditions or medications they are taking, requiring caution. Finally, this medication should be kept out of reach of children, and any abnormal reactions during use should be reported to healthcare professionals immediately.
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, unusual dreams, depersonalization, elevated mood, euphoric mood, thought disturbances, sexual dysfunction, bruxism, 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, chorea, convulsions, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, 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 disturbances, weakness, agitation, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver or pulmonary-related reactions, suicidal ideation, suicidal behavior, increased risk of fractures, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behaviors, akathisia, psychomotor restlessness
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer period.
A hard capsule with a light yellow color, filled with a grayish-white powder.
30 capsules/bottle, 500 capsules/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.