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

MFDS item code 202009262 · Approved 2020.12.28
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
This medication is primarily used for the treatment of depression. Depression can be accompanied by symptoms such as persistent sadness, changes in appetite or sleep, fatigue, feelings of guilt, and decreased concentration. This drug is known to show improvement in symptoms within 5 to 6 weeks in patients with depression. It is also used for treating bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. Efficacy in relieving symptoms has been confirmed in each condition, but regular evaluation of the utility for each patient is necessary during long-term treatment. Therefore, this medication is used for depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.
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 daily were administered. If no improvement is observed, a dose increase 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, but psychopharmacologists recognize that acute episodes of depression require medication 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. The daily dose should not exceed 80mg. Measure electrolyte levels 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 medications, elderly patients, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. 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 have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. 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, 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 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 risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or with intravenous doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.
This medication is primarily used to treat psychiatric symptoms associated with depression. There is an increased risk of suicidal impulses or behaviors while taking this medication, particularly for young patients aged 18 to 24, who should be closely monitored. Patients allergic to this medication or its ingredients, patients with severe renal function impairment, and those currently taking certain types of medications (MAO inhibitors) should not take this medication. Patients with a history of seizures or high risk of suicide should be highly cautious when taking this medication and consult their healthcare provider immediately if symptoms worsen or any abnormal behavior changes occur. Patients with heart problems or liver or kidney function impairment should also exercise caution when taking this medication. Diabetic patients may experience changes in blood sugar control, so blood sugar should be checked regularly, and treatment adjustments made if necessary. This medication can dilate pupils, so patients at risk for intraocular pressure elevation or glaucoma should consult a doctor before use. Common side effects may include headaches, nausea, insomnia, fatigue, diarrhea, etc. If severe allergic reactions or rashes occur, stop taking the medication immediately and inform a healthcare provider. Suddenly stopping this medication can lead to withdrawal symptoms such as dizziness, sensory abnormalities, sleep disturbances, anxiety, nausea, tremors, etc., so doses should be gradually reduced as per a doctor's instructions. As this medication may interact with other drugs, consult a doctor or pharmacist before starting any new medication or changing ongoing medications. Women who are pregnant or breastfeeding should consult a specialist before taking this medication, as it may affect the fetus or baby. Safety and efficacy have not been sufficiently established for children or adolescents, so it is not recommended for them. Older adults may have an increased risk of side effects based on other diseases or medications they are taking, so caution is advised. In cases of overdose, symptoms such as nausea, vomiting, seizures, and heart problems may occur, necessitating immediate medical attention. This medication should be kept out of reach of children.
Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, neuropathy, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, sexual desire disorder, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disorders, somnolence, drowsiness, tremors, psychomotor hyperactivity, movement disorders, ataxia, balance disorders, tonic muscle spasms, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency to bruising, diaphoresis, angioedema, purpura, photosensitivity reaction, petechiae, polymorphic erythema, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, urinary dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behavior, behaviors related to suicide, hostility, manic reactions, growth delay, sexual maturation delay, sexual dysfunction, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia, 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, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, psychomotor agitation
Not everyone experiences these, and they can vary from person to person.
This medication may be sensitive to air or humidity, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius.
A green capsule filled with white or grayish-white powder
30 capsules/bottle, 200 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.