Medication info
Fluoxetine 20 mg Tablets (Fluoxetine Hydrochloride)

Fluoxetine 20 mg Tablets (Fluoxetine Hydrochloride)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 tablet
Manufacturer / importer
Genewon Science Co., Ltd.
Appearance
Turquoise round film-coated tablets
Packaging
Bottle - 30 tablets/bottle, Bottle - 500 tablets/bottle
Approval status
Active

MFDS item code 202102809 · Approved 2021.03.31

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and binge-eating disorder
Who uses it
Adults
Adult dosage
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 daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80 mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists recognize that acute symptoms 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 stability. 2. Bulimia nervosa Administer 60 mg of this drug daily. The daily dose should not exceed 80 mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg of this drug daily. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug daily. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant diseases: 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 psychiatric disorders and starting treatment with this drug, 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 drug. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. If the patient requires more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. If it may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug, and there are no alternative drugs to linezolid or intravenous methylene blue 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. Monitor the patient 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 comes first. Treatment with this drug may be resumed 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 intravenous administration of this drug at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Genewon Science Co., Ltd.

Efficacy & effects

Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and binge-eating disorder

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation
  • psychomotor retardation
  • lack of interest
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • decreased concentration
View approved original text

This medication shows effects on mood improvement in patients with depression within 5-6 weeks and is used to alleviate persistent feelings of sadness and related symptoms that interfere with daily life. Additionally, it reduces binge eating and purging behaviors in cases of bulimia nervosa. It also decreases obsessive thoughts and behaviors in patients with obsessive-compulsive disorder, improving discomfort in social and work life. Furthermore, it helps alleviate symptoms such as depression, anxiety, and physical pain related to premenstrual dysphoric disorder. Long-term use requires continuous evaluation of effectiveness for each individual. Overall, this medication effectively improves various mental and neurological symptoms.

Dosage and Administration

Adult dosage

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 daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80 mg daily should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists recognize that acute symptoms 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 stability. 2. Bulimia nervosa Administer 60 mg of this drug daily. The daily dose should not exceed 80 mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg of this drug daily. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug daily. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant diseases: 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 psychiatric disorders and starting treatment with this drug, 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 drug. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. If the patient requires more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. If it may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug, and there are no alternative drugs to linezolid or intravenous methylene blue 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. Monitor the patient 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 comes first. Treatment with this drug may be resumed 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 intravenous administration of this drug at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is primarily used to treat psychiatric disorders such as depression. However, suicidal thoughts or behaviors may increase during treatment, especially in adolescents and young adults aged 18-24, so it is important to consult a physician thoroughly before taking the medication. This medication should not be administered to individuals with allergies to this drug or its components, serious kidney dysfunction, or those taking certain other medications (MAO inhibitors). Those with a history of seizures should exercise particular caution when using this drug, and if seizures occur frequently, the physician should be consulted immediately. Additionally, patients with depression at high risk for suicide require careful monitoring, especially during the initial stages of treatment and when changing doses. Individuals with heart disease or those at risk for QT interval prolongation should undergo an electrocardiogram before taking this medication and should be closely monitored during treatment. Patients with impaired liver or kidney function should have their dosage adjusted, and diabetic patients should frequently monitor their blood glucose levels as this medication may affect glucose control. This medication may cause pupil dilation, thus patients with elevated intraocular pressure or at risk for glaucoma should be cautious. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, while serious allergic reactions, liver dysfunction, or bleeding can occur in rare cases. Abruptly discontinuing this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea; therefore, the dosage should be gradually reduced under a doctor's guidance. Furthermore, this medication can interact with other drugs, so if other medications are being taken, a doctor or pharmacist should be informed, and alcohol consumption should be avoided. Pregnant or breastfeeding women should consult healthcare professionals before taking this medication, as it may affect the fetus or newborn. Lastly, this medication has not been adequately proven to be safe and effective for children and adolescents and is generally not recommended. The elderly should also take caution, and in case of overdose, immediate medical attention is necessary.

Side effects

headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disturbance, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonic jerks, convulsions, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, hair loss, increased tendency for bruising, cold sweats, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, voiding disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, persistent erection, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, anxiety, nausea, vomiting, tremors, headache, anaphylactic reaction, progressive systemic reaction, severe skin, kidney, liver, or pulmonary-related reactions, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, 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 and exacerbation of existing 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.

Storage

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 25 degrees Celsius at room temperature. This preserves the drug's effectiveness and safety for a longer time.

Appearance and packaging

Appearance

Turquoise round film-coated tablets

Package unit

Bottle - 30 tablets/bottle, Bottle - 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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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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.