Medication info
Fluzen Capsule (Fluoxetine Hydrochloride)

Fluzen Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Celix Co., Ltd.
Appearance
A hard capsule with a green upper part and a pale yellow lower part, filled with a white or grayish white powder.
Packaging
300 capsules per bottle, 30 capsules per bottle
Approval status
Active

MFDS item code 200401879 · Notified 2004.06.17

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 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20~80mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of an adequate 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 drug; however, psychopharmacologists recognize 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 stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with concurrent illnesses: Use 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 drug, 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 since 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 for a psychiatric condition, including hospitalization or other interventions, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to patients 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, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor patients 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 such use.

Ingredients

Manufacturer
Celix 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 retardation of mental activity
  • loss of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowing of thought processes
  • decreased concentration
  • suicide attempts
View approved original text

This medication is primarily used for the treatment of depression and is effective in alleviating persistent feelings of sadness and related symptoms that impair everyday functioning. It also helps reduce binge eating and bowel issues in patients with bulimia nervosa. It decreases obsessive thoughts and behaviors associated with obsessive-compulsive disorders, mitigating their negative impact on social and work life. It is also used to improve depression, anxiety, and physical symptoms in patients with premenstrual dysphoric disorder. However, regular assessments of efficacy may be required for long-term users.

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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of an adequate 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 drug; however, psychopharmacologists recognize 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 stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older patients, and patients with concurrent illnesses: Use 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 drug, 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 since 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 for a psychiatric condition, including hospitalization or other interventions, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to patients 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, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor patients 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 such use.

Precautions

This medication is an antidepressant used to treat mental health issues such as depression. During treatment, there may be an increase in thoughts or behaviors related to suicide, especially in young patients aged 18 to 24, who should be monitored closely. If the patient or caregiver notices worsening depression, suicidal impulses, aggressive behavior, or changes in behavior, they should immediately consult healthcare professionals. This drug should not be used in specific patients, such as those with severe kidney impairment, those allergic to this medication or its components, and those taking certain other medications. Patients with a history of seizures should also use caution when taking this medication, and if seizures increase, the drug use should be discontinued. Patients with heart disease or liver dysfunction should consult a doctor before taking this medication, as serious side effects like cardiac arrhythmias may occur. Diabetic patients who need blood sugar control should closely monitor their blood sugar levels while taking this medication, and dosage adjustments may be necessary. This medication may cause dilated pupils, so caution is especially needed for patients with glaucoma. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, and if a severe allergic reaction or skin rash occurs, the medication should be stopped immediately and healthcare professionals should be consulted. Sudden discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, insomnia, and headaches, so doses must be gradually reduced under a doctor's guidance. Furthermore, this medication may interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. Pregnant or breastfeeding women should carefully consider the benefits and risks of taking this medication, as it may transfer into breast milk. Safety and efficacy in children and adolescents have not been adequately confirmed, and use is not recommended. In elderly patients, the risk of side effects may vary based on other health conditions or medications, so caution is needed. Finally, this medication should be stored out of reach of children, and it is safe not to 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, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, derealization, elevated mood, euphoric mood, thought disturbances, sexual dysfunction, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, dysgeusia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, seizures, inability to sit still, Buccoglossal 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, diaphoresis, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, muscle strain, myalgia, frequent urination, dysuria, urinary retention, urination disorders, 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 tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver, or lung-related reactions, growth delay, delayed puberty development, Stevens-Johnson syndrome, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, 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

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 is best kept at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

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

Package unit

300 capsules per bottle, 30 capsules per 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.