Viewing nowObetain Capsule 20 mg (Fluoxetine Hydrochloride)
Fluoxetine Hydrochloride 22.4mg
Hard capsule · Prescription medication
Introvio Pharma Co., Ltd.

MFDS item code 202106605 · Approved 2021.09.17
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
This medication is primarily used to alleviate symptoms in patients with depression. Depression is characterized by persistent feelings of sadness and discomfort, changes in appetite and sleep, and difficulty concentrating. This medication typically shows improvements in these depressive symptoms within about 5-6 weeks. Additionally, it helps reduce excessive appetite and laxative behavior in patients with bulimia nervosa. For individuals with obsessive-compulsive disorder, this medication can decrease obsessive thoughts and behaviors, thereby aiding social and occupational functioning. It is also effective in alleviating depressive, anxious, and physical pain symptoms associated with premenstrual dysphoric disorder. However, regular evaluations of effectiveness are necessary for long-term use. Overall, this medication is used to improve the symptoms of depression and other related psychiatric and neurological disorders.
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 daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks or longer after treatment begins. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists agree 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 drug daily. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower 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 a psychiatric disorder and starting treatment with this drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have passed since discontinuing this drug. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this drug 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 an antidepressant used to treat depression and certain psychiatric disorders. It may increase the risk of suicidal thoughts or behavior when used in children, adolescents, and young adults aged 18 to 24. Therefore, careful evaluation by a physician is essential before administering to this age group. Particularly, patients with a high risk of suicide or psychiatric disorders should be closely monitored during the initial weeks of treatment for worsening symptoms, suicidal thoughts, or changes in behavior such as aggression. This medication should not be administered to certain patients, including those who are allergic to this medication or its components, those with severe renal impairment, and those currently taking a specific class of drugs known as MAO inhibitors. Patients with genetic metabolic disorders such as galactose intolerance or lactase deficiency should also avoid this medication. Patients with a history of seizures should be cautious, as this medication may worsen seizure activity, and those with a history of manic or hypomanic episodes should also be monitored closely. For patients with heart conditions or at risk for QT interval prolongation, an ECG is recommended due to potential effects on cardiac rhythm. Patients with hepatic or renal impairment may require dosage adjustments or careful monitoring. Diabetic patients may experience changes in blood glucose control while taking this medication, so regular monitoring is essential. Caution is warranted for patients who may experience pupil dilation, as this could increase the risk of elevated intraocular pressure or glaucoma. Common side effects include headache, nausea, insomnia, fatigue, and diarrhea, while rare but serious side effects may involve severe allergic reactions, liver dysfunction, bleeding, and psychiatric symptoms. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, paresthesia, anxiety, nausea, tremors, headache, so it should be tapered off under a physician's guidance. This medication may interact with other drugs, so it is crucial to inform your doctor or pharmacist of any other medications you are currently taking. Particularly, co-administration with MAO inhibitors or serotonergic drugs poses a risk of developing a severe side effect known as serotonin syndrome, so concurrent use should be avoided. During pregnancy, the risks to the fetus must be carefully weighed against the benefits of this medication, and during breastfeeding, consideration must be given to its secretion in breast milk and potential impact on the infant. Use in children and adolescents is not recommended due to insufficient data on safety and efficacy. Older adults require special assessment, and interactions with other diseases or medications must be carefully considered. In case of overdose, serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, necessitating immediate medical attention. This medication may be sensitive to light and moisture, so it should be stored in a tightly closed container out of reach of children, and it is advisable not to transfer it to another container. Lastly, it is important to exercise caution while driving or operating machinery during treatment, and avoiding alcohol consumption is advisable.
Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, reduced libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, 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, dyskinesia, ataxia, balance disorders, myoclonus, seizures, inability to sit still, buccoglosso-pharyngeal syndrome, serotonin syndrome, memory disorders, 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 for bruising, diaphoresis, angioedema, petechia, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myopathy, myalgia, frequent urination, dysuria, urinary retention, urination 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, dizziness, sensory disturbance, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, gradual systemic reactions, behavior related to suicide, hostility, growth delay, decreased alkaline phosphatase, platelet function changes, 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, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening of 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 may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best kept at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.
A hard capsule with a green upper and yellowish-green lower, filled with a white to off-white powder
Bottle packaging - 30 capsules/bottle, Bottle packaging - 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.