Viewing nowPMS Fluoxetine Capsule 10 Milligrams (Fluoxetine Hydrochloride)
Fluoxetine Hydrochloride 11.18mg
Hard capsule · Prescription medication
Pharma Science Korea Co., Ltd.

MFDS item code 201405194 · Approved 2014.11.06 · Insurance code 627600070
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), premenstrual dysphoric disorder, and bulimia nervosa
This medication is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. For depression, effects may appear within about 5 to 6 weeks, improving key symptoms such as changes in appetite and sleep, and decreased concentration. In patients with bulimia nervosa, it reduces bingeing and purging behaviors. In obsessive-compulsive disorder, it alleviates obsessive symptoms, reducing discomfort in daily life. In patients with premenstrual dysphoric disorder, it helps alleviate periodic emotional instability and physical symptoms. However, regular evaluation of individual patient conditions is important during long-term administration.
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 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 longer after the start of treatment. 2) Maintenance/continuation/long-term treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists agree that acute episodes of depression require drug treatment for several months or longer. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as the dose needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with comorbid diseases: Use a lower dose or reduce the frequency of administration. 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, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat a psychiatric disorder. 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 or other interventions, treatment may 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 weeks after receiving linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection), or with intravenous administration of this drug at a dose of 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 an antidepressant used for the treatment of psychiatric disorders like major depression. Caution is necessary when administering to children, adolescents, and young adults as there is an increased risk of suicidal thoughts or behaviors. It should not be administered to patients with hypersensitivity or severe renal impairment, nor to those taking certain medications (MAO inhibitors). It should be used cautiously in patients with a history of seizures or high suicide risk, and any changes in symptoms during treatment should be immediately discussed with a doctor. Patients with heart disease or impaired liver and kidney function should also use it cautiously, and diabetic patients requiring blood sugar control should closely monitor their blood sugar levels while taking this medication. It can cause pupil dilation, so it should be used cautiously in patients with high intraocular pressure. Rarely, severe allergic reactions or skin rashes may occur, so any unusual symptoms should be reported to a healthcare professional immediately. Discontinuing this medication abruptly can lead to withdrawal symptoms such as dizziness, anxiety, and headache; therefore, the dosage should be gradually reduced according to the doctor's instructions. There may be interactions with other medications, so all medications being taken should be reported to the doctor, and medications should not be stopped or added without consulting a healthcare professional. Women who are pregnant or breastfeeding should consult a doctor before using this medication, as it may affect the fetus or newborn; careful consideration is necessary. Safety and effectiveness in children and adolescents have not been established, and it is generally not recommended. Elderly patients also require special caution, as serious side effects can occur in the event of overdose, necessitating immediate medical intervention. This medication should be kept out of reach of children, and transferring it to other containers should be avoided as it may negatively affect product quality.
Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, loss of appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric 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, movement disorders, ataxia, balance disorders, paroxysmal muscle spasms, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, 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, alopecia, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, muscle spasms, myalgia, frequent urination, painful urination, 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, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe skin, reactions related to kidneys, liver, or lungs, suicidal ideation, suicidal behavior, hostility, growth delay, delayed puberty, Stevens-Johnson syndrome, changes in platelet function, bleeding, sitting still inability, movement disorders, 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 must be stored in a tightly sealed container. Additionally, it is best to avoid very hot or very cold environments, and to store it at a temperature between 1 degree and 30 degrees Celsius.
A hard capsule with a green upper part and a light gray lower part filled with white powder
30 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.