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

MFDS item code 201907732 · Approved 2019.11.05 · Insurance code 642005240
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder
This medication is effective for the following conditions. In depressed patients, it improves symptoms such as persistent and severe sadness, changes in appetite and sleep, fatigue, guilt, and decreased concentration within 5-6 weeks. It also helps reduce binge eating behaviors in patients with bulimia nervosa. For patients with obsessive-compulsive disorder, it alleviates obsessive thoughts and behaviors, thus reducing their impact on social and work life. In patients with premenstrual dysphoric disorder, it helps alleviate emotional instability and physical discomfort. For each symptom and disorder, it is important to regularly evaluate efficacy during long-term treatment. These efficacy attributes are used to improve patients' symptoms.
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 20~80mg per day were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses greater than 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 longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medication, but psychopharmacologists agree that acute episodes of depression require pharmacotherapy 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 improvement. 2. Bulimia nervosa Administer 60mg of this medication per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medication per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medication per day. Reassess the need for continued treatment after 6 months of therapy. - Patients with renal and/or hepatic impairment, patients taking multiple medications, older 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 medication, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this medication before starting an MAO inhibitor for treatment of a psychiatric disorder. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medication may be stopped immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or intravenous administration of this medication at doses of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.
This medication is primarily used as an antidepressant to treat psychiatric disorders related to depression. While taking this medication, the risk of suicide ideation or suicidal behavior may increase in certain age groups, especially young patients aged 18 to 24, so careful judgment and continuous monitoring by a physician is necessary. Additionally, this medication should not be used in conjunction with certain drugs, particularly MAO inhibitors, as this can lead to dangerous side effects. Patients with hypersensitivity to this medication, severe renal impairment, or genetic lactose intolerance should not take it. Patients with a history of seizures, those at high risk for suicide, those with a history of mania, and patients with heart disease should be particularly cautious when using this medication and may require regular ECG checks and monitoring as necessary. Patients with impaired liver or kidney function may need dosage adjustments, and diabetic patients should monitor their blood sugar levels closely as there may be changes in blood glucose control. Common side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur during treatment, while rare but serious side effects such as allergic reactions, bleeding, and cardiac arrhythmias have also been reported. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, and anxiety, so it is essential to gradually reduce the dosage under the supervision of a physician when stopping treatment. During pregnancy, there may be risks to the fetus, so it should only be used when absolutely necessary, and care is needed during breastfeeding as the medication can be passed through breast milk. This medication has not been sufficiently proven safe and effective for children and adolescents and is not recommended for this group. Though no specific adverse reactions have been reported in the elderly, caution is needed depending on other diseases and medications taken. Alcohol consumption should be avoided during treatment, and potential interactions with other medications should be discussed with a doctor or pharmacist. This medication may affect judgment or motor function, so caution should be exercised when driving or operating dangerous machinery.
headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, appetite loss, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses, behavioral changes, confusion, attention disorder, dizziness, taste disorder, drowsiness, tremors, psychomotor agitation, motor disturbances, ataxia, balance disorders, tics, convulsions, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related inflammation and fibrosis, nosebleed, vomiting, indigestion, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased bruising, cold sweats, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, muscular cramps, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms (dizziness, sensory disturbances, sleep disorders, weakness, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reaction, progressive systemic reaction, suicidal ideation, suicidal behavior, kidney and weight loss, growth delay, failure of ejaculation, cervical bleeding, weakness, Stevens-Johnson syndrome, platelet function changes, bleeding, inability to sit still syndrome, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, 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 avoid exposure to air or moisture. It is important to maintain a storage temperature of room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety over time.
A hard capsule with green upper and lower parts filled with a white or whitish 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.