Viewing nowFluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)
Fluoxetine Hydrochloride 11.2mg
Hard capsule · Prescription medication
Ixu Pharmaceutical Co., Ltd.

MFDS item code 202106027 · Approved 2021.08.19
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
This medication is effective in the treatment of depression, with symptom improvement typically observed within 5 to 6 weeks. Depression is characterized by persistent sadness and various symptoms that interfere with daily functioning. Additionally, it helps reduce binge eating and related behaviors in the treatment of anorexia nervosa. In obsessive-compulsive disorder, it decreases obsessive symptoms and behaviors, alleviating their negative impact on social life. In premenstrual dysphoric disorder, it is used to improve emotional and physical symptoms related to the menstrual cycle. In all cases, regular evaluation of efficacy during long-term use is important. This medication is primarily used to treat depression, anorexia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.
Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20–80 mg/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/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 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 remission. 2. Bulimia nervosa Administer 60 mg/day of this medicine. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms.
This medication is an antidepressant used to treat psychiatric disorders such as major depression. It may increase the risk of suicidal thoughts or behaviors in young people aged 18 to 24, so caution is essential when prescribing it to patients in this age group. During treatment, close monitoring for worsening depressive symptoms, suicidal thoughts, aggression, or other abnormal behavioral changes is necessary, and family or caregivers should also be vigilant. This medication should not be administered to specific patients, such as those with allergies to the drug or its excipients, those with severe renal impairment, and those taking MAO inhibitors. Patients with a history of seizures or a high risk of suicide should use this medication with additional caution, and if symptoms worsen during use, they should consult a healthcare professional immediately. Patients with heart disease or impaired liver or kidney function should also be cautious when taking this medication, and diabetic patients who require blood sugar control should monitor for changes in blood sugar levels while taking this medication. This medication may rarely cause side effects such as headache, nausea, insomnia, fatigue, and diarrhea, and severe allergic reactions, bleeding, or unstable heart rhythms may occur. If any unusual symptoms arise, healthcare professionals should be notified immediately. Pregnant or breastfeeding women should consult a doctor before taking this medication, as it may affect the fetus or newborn. The safety and efficacy of this medication in children and adolescents have not been sufficiently demonstrated, so its use is not recommended in this age group. While taking this medication, alcohol should be avoided, and any other medications should be disclosed to a doctor due to potential interactions. Also, abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced per the doctor’s guidance. Finally, this medication should be stored in a safe place out of reach of children, and it is not advisable to change the storage container arbitrarily.
Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, euphoric mood, dysphoria, abnormal sexual desire, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonic jerks, seizures, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, 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, alopecia, tendency for increased bruising, diaphoresis, angioedema, petechial hemorrhage, photosensitivity, 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, fatigue, abnormal mood, feeling cold, feeling hot, mucosal hemorrhage, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, renal, hepatic, or pulmonary reactions, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, rash, allergic symptoms, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, 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, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior
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 or moisture. In addition, it is best to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain its effectiveness and safety.
Green capsules filled with white or grayish-white powder
30 capsules/bottle, 300 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.