Medication info
Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 tablet
Manufacturer / importer
Mirae Bio Pharmaceutical Co., Ltd.
Appearance
Hard capsule with upper green and lower yellowish color filled with a whitish powder.
Packaging
Bottle - 30 capsules/bottle, Bottle - 300 capsules/bottle, Bottle - 500 capsules/bottle
Approval status
Active

MFDS item code 201310001 · Approved 2013.10.31

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg orally once daily in the morning. In controlled clinical trials, doses of 20~80mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (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 of treatment or longer. 2) Maintenance/continuation/extended 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 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. 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 necessary. 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 frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to an MAO inhibitor for the treatment of 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 elapse 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. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment should be considered. If linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this drug, and there is no alternative 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, discontinue this drug immediately and administer linezolid or intravenous methylene blue. 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 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 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
Mirae Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or lethargy in psychomotor activity
  • lack of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thought processes
  • decreased concentration
  • suicide attempts
View approved original text

This medication is primarily used effectively for depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. Symptoms in depression patients typically show improvement within about 5-6 weeks, alleviating various symptoms related to depressive states. In bulimia nervosa, it helps reduce binge eating and purging behaviors to aid in appetite control. For those with obsessive-compulsive disorder, it reduces symptoms related to compulsive behaviors, easing inconveniences in daily life. In patients with premenstrual dysphoric disorder, it helps alleviate recurrent symptoms of depression, anxiety, and physical symptoms. However, it is important to regularly assess the patient's condition during long-term use to reaffirm the medication's usefulness. This medication is used for symptom improvement of these conditions.

Dosage and Administration

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg orally once daily in the morning. In controlled clinical trials, doses of 20~80mg daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (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 of treatment or longer. 2) Maintenance/continuation/extended 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 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. 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 necessary. 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 frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to an MAO inhibitor for the treatment of 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 elapse 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. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment should be considered. If linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this drug, and there is no alternative 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, discontinue this drug immediately and administer linezolid or intravenous methylene blue. 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 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 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 mental health issues such as depression. During the course of taking this medication, particularly in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behavior, so caution is essential. Patients with allergies to this medication or its ingredients, severe kidney issues, or those taking specific types of other medications (MAO inhibitors) should not take this medication. Patients with a history of seizures or a high risk of suicide, those with symptoms of mania, or issues with heart, liver, or kidney function should use this medication with caution. Patients with diabetes should monitor their blood sugar levels frequently as this medication may affect blood sugar control. Caution is also needed for patients at risk of increased ocular pressure and glaucoma. Common side effects of this medication include headache, nausea, insomnia, fatigue, diarrhea, and reduced appetite; however, there may be rare, serious side effects such as allergic reactions, cardiac arrhythmias, bleeding, and skin rashes. Close observation for changes in mental state such as suicidal thoughts or behavior, anxiety, or aggression is necessary, especially at the beginning of treatment or when changing dosages, and family members or guardians should also be vigilant about these changes. This medication may interact with other drugs; thus, any other medications being taken should be disclosed to a physician or pharmacist, and alcohol consumption should be avoided. Women who are pregnant or breastfeeding must consult a doctor before taking this medication, as it may affect the fetus or newborn. Its safety and efficacy have not been sufficiently established for use in children and adolescents. In cases of overdose, symptoms such as vomiting, seizures, and heart issues may occur, requiring immediate medical attention; do not suddenly discontinue the medication but taper off it as directed by a physician. Finally, this medication should be stored out of reach of children and should not be transferred to other containers.

Side effects

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 disorder, abnormal dreams, derealization, elevated mood, elation, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal ideation and behavior, confusion, attention deficit, dizziness, taste disorder, somnolence, drowsiness, tremor, psychomotor agitation, movement disorder, ataxia, balance disorder, myoclonus, convulsion, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, respiratory-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal hemorrhage, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, muscular cramps, myalgia, pollakiuria, dysuria, urine retention, urinary dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function values, dizziness, sensory disturbance, sleep disorder, asthenia, agitation, anxiety, nausea, vomiting, tremor, headache, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, motor 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 should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Hard capsule with upper green and lower yellowish color filled with a whitish powder.

Package unit

Bottle - 30 capsules/bottle, Bottle - 300 capsules/bottle, Bottle - 500 capsules/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.