Medication info
Flutin Capsule (Fluoxetine Hydrochloride)

Flutin Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Daewon Pharm Co., Ltd.
Appearance
A hard capsule with a green upper part and a light yellow lower part containing a white to off-white powder.
Packaging
For domestic use: 30 capsules/bottle, 300 capsules/bottle; for export: 100 capsules (10 capsules/PTPX10)
Approval status
Active

MFDS item code 199901556 · Notified 1999.09.22 · Insurance code 671803560

Summary

Main use
Treatment of psychiatric disorders (depression, obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric 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/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/day 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 medication; however, psychopharmacologists recognize that acute episodes of depression require medication treatment for several months or longer. It is not known whether the amount of antidepressant needed to achieve symptom relief is the same as that needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60 mg/day of this medication. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medication. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medication. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid conditions: 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 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this medication. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization, other interventions 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medication 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 occurs first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at doses of 1 mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Daewon Pharm Co., Ltd.

Efficacy & effects

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

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

This medication is effective for various mental health conditions including depression, anorexia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. When treating depression, it helps improve persistent feelings of sadness and related symptoms that interfere with daily life within 5-6 weeks. In cases of anorexia nervosa, it reduces binge eating and purging behaviors. For obsessive-compulsive disorder, it helps reduce obsessive thoughts and behaviors, thus mitigating their negative impacts on social and work life. It also contributes to alleviating symptoms of premenstrual dysphoric disorder, such as depression, anxiety, and physical pain. However, the therapeutic effect should be regularly evaluated for long-term use in all diseases. This medication is used for the improvement of these 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/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg/day should be administered twice daily (morning and noon), and the maximum dose of 80 mg/day 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 medication; however, psychopharmacologists recognize that acute episodes of depression require medication treatment for several months or longer. It is not known whether the amount of antidepressant needed to achieve symptom relief is the same as that needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60 mg/day of this medication. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medication. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medication. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid conditions: 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 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 5 weeks must have elapsed after discontinuing this medication. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization, other interventions 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medication 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 occurs first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medication at doses of 1 mg/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 an antidepressant used for treating psychiatric disorders such as major depression. This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so careful evaluation of risks and benefits by a physician is necessary when used in these age groups. This medication should not be used in certain patients, such as those who have allergies to this medication or its additives, severe renal impairment, or are currently taking MAO inhibitors. Patients with a history of seizures should exercise caution when using this medication and must discontinue treatment immediately if seizures occur or worsen. In the early stages of treatment, there may be worsening depression symptoms or abnormal behaviors such as suicidal thoughts, aggression, or anger, so the patient and guardians should closely monitor for these symptoms and consult a physician immediately if they occur. Patients with cardiovascular disorders or impaired liver and kidney function should use this medication cautiously and may need to undergo electrocardiograms and blood tests as necessary. This medication may affect blood sugar control, so diabetic patients should regularly monitor their blood sugar levels and may require adjustments to their medication dosage. It is advisable to avoid alcohol consumption while taking this medication and consult a physician or pharmacist about potential interactions when used with other medications. Pregnant or breastfeeding women should consult a physician before taking this medication, and careful decisions should be made considering its effects on the fetus and newborn. This medication has not been established for safety and efficacy in children and adolescents, so its use is not recommended when possible. Abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, and headaches, so the dosage should be gradually reduced according to a physician's instructions. When storing this medication, keep it in a safe place out of the reach of children and do not transfer it to other containers.

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 disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behavior, confusion, attention deficit disorder, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, cramps, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory disorders, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rashes, urticaria, pruritus, hyperhidrosis, alopecia, tendency to bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, nausea, vomiting, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, 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, 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.

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, maintaining storage temperatures between 1°C and 30°C room temperature. This will safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

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

Package unit

For domestic use: 30 capsules/bottle, 300 capsules/bottle; for export: 100 capsules (10 capsules/PTPX10)

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.