Medication info
Flutin Capsule 10 mg (Fluoxetine Hydrochloride)

Flutin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a green upper and lower part filled with a white or grayish powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200301251 · Notified 2003.09.15 · Insurance code 671803570

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
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 the 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 sufficient antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine. However, psychopharmacologists agree 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 improvement. 2. Bulimia nervosa Administer 60 mg/day of this medicine. Do not exceed 80 mg/day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. Do not exceed 80 mg/day. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. 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 illnesses: 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 a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 medicine. If there is no alternative to linezolid or intravenous methylene blue 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 medicine 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 for 24 hours after the last dose, whichever occurs first. Treatment with this medicine 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 medicine at a dose of 1 mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Depression
  • change in appetite
  • change in sleep
  • agitation or retardation of psychomotor activity
  • lack of interest in daily life
  • reduced sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • decreased concentration
  • suicide attempts
View approved original text

This medication is used for various mental and physical disorders. For patients with depression, the therapeutic effect of this medication appears within 5-6 weeks and helps improve persistent and severe depressive states. Additionally, it is effective in reducing binge eating and excessive bowel movements in patients with bulimia nervosa. In obsessive-compulsive disorder, it decreases obsessive thoughts or behaviors to ease difficulties in daily life. Furthermore, it is used to improve emotional instability and physical symptoms caused by premenstrual dysphoric disorder. However, it is crucial to regularly assess the efficacy for individual patients during long-term use. This medication is used for the treatment of depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

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 the 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 sufficient antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine. However, psychopharmacologists agree 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 improvement. 2. Bulimia nervosa Administer 60 mg/day of this medicine. Do not exceed 80 mg/day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg/day of this medicine. Do not exceed 80 mg/day. 4. Premenstrual dysphoric disorder Administer 20 mg/day of this medicine. 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 illnesses: 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 a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of a psychiatric disorder. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 medicine. If there is no alternative to linezolid or intravenous methylene blue 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 medicine 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 for 24 hours after the last dose, whichever occurs first. Treatment with this medicine 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 medicine at a dose of 1 mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is an antidepressant used for the treatment of psychiatric disorders such as depression. It may increase the risk of suicidal thoughts or behaviors, especially in younger patients aged 18 to 24; hence, physicians should carefully evaluate the risks and benefits when prescribing this medication to this age group. Patients with hypersensitivity or severe renal impairment, and those taking certain types of medications such as MAO inhibitors, should not use this medication. Caution is necessary in patients with a history of seizures, and treatment should be discontinued immediately if seizures occur or their frequency increases. This medication may affect heart function; thus, patients with heart disease or those with abnormalities such as prolonged QT interval are encouraged to undergo an ECG before administration. Patients with impaired liver or kidney function may require dosage adjustment, and diabetic patients should be cautious with blood sugar control. Additionally, this medication can cause pupil dilation, so patients at risk of increased intraocular pressure or glaucoma should use it cautiously. Common side effects during administration may include headache, nausea, insomnia, fatigue, and diarrhea; if severe allergic reactions or skin rashes occur, medical attention should be sought immediately. Discontinuation of this medication suddenly may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors, so the dosage should be gradually reduced following a physician's guidance. Moreover, interactions with other medications, including antidepressants, may occur, so it is essential to consult healthcare professionals if taking or planning to take other medications. Women who are pregnant or breastfeeding should thoroughly discuss with their physician the potential effects of this medication on the fetus or newborn before taking it. Finally, safety has not been established for children and adolescents; thus, this medication is not recommended, and caution is also necessary for elderly patients. It is crucial to store this medication out of reach of children and not to transfer it to other containers.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, 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 disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorders, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, seizures, inability to sit still, Buccglosal 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, hair loss, increased tendency for bruising, sweating, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, restlessness, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbance, asthenia, restlessness, anxiety, tremors, headache, anaphylactoid reactions, gradual systemic reactions, severe reactions involving the skin, kidneys, liver, or lungs, weight loss, growth retardation, delayed puberty, hypoglycemia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, 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, inability to sit still, psychomotor agitation

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is advisable to store it at room temperature, not too hot or too cold, between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

A hard capsule with a green upper and lower part filled with a white or grayish powder.

Package unit

30 capsules/bottle, 100 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.