Medication info

Flotin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Medica Korea Co., Ltd.
Appearance
A green capsule filled with white or grayish-white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 202107104 · Approved 2021.10.25

Summary

Main use
Treatment of 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 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20~80mg/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses greater than 20mg/day should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg/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 generally 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg/day of this medicine. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg/day of this medicine. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg/day of this medicine. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a low dose or reduce the dosing frequency. Adjust the dose appropriately 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 medicine. Conversely, at least 5 weeks should elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. 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 are no alternative treatments 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 medicine 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this medicine at 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
Medica Korea Co., Ltd.

Efficacy & effects

Treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder

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

This medication helps alleviate persistent feelings of depression and related symptoms in patients with depression. Effects may be observed within 5-6 weeks, especially in those experiencing changes in appetite, sleep disturbances, increased fatigue, and decreased concentration. It is also used to reduce symptoms of obsessive-compulsive disorder, improving discomfort in social or work environments. It is effective in reducing binge eating and purging behavior in patients with bulimia nervosa. Additionally, it helps relieve symptoms such as depression, anxiety, and physical discomfort associated with premenstrual dysphoric disorder. This medication is indicated for the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Adults 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/day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses greater than 20mg/day should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg/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 generally 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg/day of this medicine. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg/day of this medicine. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg/day of this medicine. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a low dose or reduce the dosing frequency. Adjust the dose appropriately 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 medicine. Conversely, at least 5 weeks should elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. 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 are no alternative treatments 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 medicine 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this medicine at 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 should be used with caution in children or adolescents with major depressive disorder or psychiatric conditions, as there may be an increased risk of suicidal thoughts and behaviors. It should not be administered to patients with a known allergy to this medication, severe kidney dysfunction, or those taking certain medications known as MAO inhibitors. Caution is required for patients with a history of seizures, and those at risk of suicide should be closely monitored during the initial treatment phase and when changing doses. Patients with heart disease, reduced liver function, diabetes, and those with high intraocular pressure or at risk for glaucoma should use this medication with special caution. This medication can cause various side effects, including headaches, nausea, insomnia, fatigue, and diarrhea, and any unusual symptoms should be reported to a physician immediately. Discontinuation may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; hence, a gradual reduction in dosage is recommended. Additionally, this medication may interact with several drugs; thus, inform your physician if you are taking or planning to take other medications. Women who are pregnant or breastfeeding should carefully consider the effects on the fetus and infant and consult a specialist if necessary. Safety and efficacy have not been sufficiently established in children and adolescents, and use in this population should be avoided. Elderly patients may experience abnormal reactions due to other conditions or medications, requiring careful monitoring. In case of overdose, serious symptoms such as nausea, seizures, or heart issues could arise, and immediate medical attention is needed. Finally, this medication should be kept out of the reach of children and should not be transferred to another container for safety reasons.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, loss of appetite, hyponatremia, anxiety, irritability, restlessness, tension, reduced libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behavior, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor hyperactivity, movement disorders, ataxia, balance disorders, tonic-clonic seizures, spasms, inability to sit still, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increase in tendency to bruise, cold sweat, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, persistent erection, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal thoughts, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic response, severe reactions related to skin, kidney, liver, or lungs, growth delay, ejaculation failure, ejaculation disorder, premature ejaculation, delayed ejaculation, retrograde ejaculation, cervical bleeding, uterine dysfunction, uterine bleeding, genital bleeding, functional uterine bleeding, menorrhagia, frequent menstruation, postmenopausal bleeding, vaginal bleeding, asthenia, Stevens-Johnson syndrome, hemorrhagic diarrhea, melena, gastric ulcer bleeding, persistent symptoms of sexual dysfunction, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorder, 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 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 moisture, so it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the safety of the medication's efficacy.

Appearance and packaging

Appearance

A green capsule filled with white or 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.