Medication info
Fluoxetine Capsule (Fluoxetine Hydrochloride)

Fluoxetine Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Seongyi Bio Pharmaceutical Co., Ltd.
Appearance
A hard capsule with green upper part and light yellow lower part containing a white to grayish-white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 202106361 · Approved 2021.09.03

Summary

Main use
Treatment of mental disorders (depression, obsessive-compulsive disorder), premenstrual dysphoric disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
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, an increase in dose 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 several months or more of drug therapy. 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. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, 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 MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue This drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. In patients who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, consider administering treatment. 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 judged to outweigh the risk of serotonin syndrome, 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 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 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.

Ingredients

Manufacturer
Seongyi Bio Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or retardation of psychomotor activity
  • lack of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feeling worthless
  • slowing of thought
  • decreased concentration
  • suicidal attempts
View approved original text

This medication is primarily used for the treatment of depression, which is a condition accompanied by various symptoms including a persistently low mood or discomfort lasting for at least 2 weeks. It is also effective in alleviating problems related to neurogenic hyperphagia, or excessive appetite. In obsessive-compulsive disorder, it helps reduce the distress caused by obsessive thoughts and behaviors, improving the impact on social or work life. This medication aids in alleviating depression, anxiety, and physical symptoms related to premenstrual dysphoric disorder, thus enhancing the quality of daily life. It is important to regularly assess the condition of individual patients with long-term use. In summary, this medication is used to improve various mental and some physical symptoms such as depression, neurogenic hyperphagia, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

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, an increase in dose 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 several months or more of drug therapy. 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. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, 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 MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue This drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. In patients who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, consider administering treatment. 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 judged to outweigh the risk of serotonin syndrome, 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 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 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.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depression or psychiatric disorders, so it is essential to consult a doctor before use. This medication should not be administered to specific patients, such as those allergic to this medication or its additives, patients with severe kidney dysfunction, and those taking certain medications (MAO inhibitors). Patients with a history of seizures or those at high risk of suicide, as well as patients with mania or heart disease, require special caution when using this medication, and regular observation and monitoring are crucial. Since this medication is metabolized and excreted through the liver and kidneys, dose adjustment may be necessary for patients with impaired liver or kidney function. Patients with diabetes may experience changes in blood sugar control while taking this medication and should monitor their blood sugar periodically. This medication can dilate the pupils and increase intraocular pressure, so patients at risk for glaucoma should use it with caution. Common side effects during usage include headache, nausea, insomnia, fatigue, and diarrhea; if severe allergic reactions or unusual symptoms such as suicidal impulses appear, medical personnel should be notified immediately. Abruptly stopping this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so dosage should be gradually reduced according to the doctor's instructions. There may be interactions with other medications, so if you are taking other medications, it is essential to inform your doctor or pharmacist, particularly when combining with MAO inhibitors, anticoagulants, or certain antidepressants. Pregnant or breastfeeding women should use this medication only after consulting with health professionals, as its use may affect the fetus or newborn. Safety and efficacy have not been established in children and adolescents, so use is not recommended. Elderly patients are at increased risk for adverse reactions depending on underlying conditions or other medications, so caution is advised during use. In case of overdose, symptoms such as nausea, seizures, cardiac abnormalities may occur, requiring immediate treatment at a hospital; there is no specific antidote, so symptomatic treatment is necessary. This medication should be kept out of reach of children and should not be transferred to other containers. Judgment and motor skills may be affected during use, so caution is necessary when driving a car or operating dangerous machinery.

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, happy mood, thought disturbances, sexual desire abnormalities, 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, tics, convulsions, inability to sit still, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, dilation of pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, cold sweats, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequency of urination, dysuria, urinary retention, voiding dysfunction, 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, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, 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, 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 closed container to prevent exposure to air or moisture, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. By storing it this way, the efficacy of the medication will be maintained for a long time, preventing deterioration.

Appearance and packaging

Appearance

A hard capsule with green upper part and light yellow lower part containing a white to grayish-white powder

Package unit

30 capsules/bottle, 300 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.