Medication info
Polsetin Capsule 10mg (Fluoxetine Hydrochloride)

Polsetin Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
RP Bio Co., Ltd.
Appearance
A green capsule filled with white or grayish-white powder
Packaging
For domestic use - 30 capsules/bottle, For domestic use - 300 capsules/bottle
Approval status
Active

MFDS item code 202107002 · Approved 2021.10.19

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 daily were administered. If no improvement is observed, an increase in dosage 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 of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists agree 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 daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations 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. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid illnesses: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately 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 after 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration should be considered. 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, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 comes first. Treatment with this drug may be restarted 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 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 these uses.

Ingredients

Manufacturer
RP Bio Co., Ltd.

Efficacy & effects

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

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

This medication is effective in treating depression, with symptom improvement observed within 5 to 6 weeks for daily life disturbances caused by depressive symptoms. It also helps reduce binge eating and purging behavior in bulimia nervosa. It decreases obsessive symptoms of obsessive-compulsive disorder, thereby reducing the impact on social and occupational life. It is also used to alleviate depression, anxiety, and physical symptoms associated with premenstrual dysphoric disorder. However, the effectiveness for all symptoms should be regularly reassessed in individual patients for 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 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 dosage 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 of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists agree 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 daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations 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. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid illnesses: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately 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 after 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, administration should be considered. 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, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 comes first. Treatment with this drug may be restarted 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 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 these uses.

Precautions

This medication is primarily used as an antidepressant to treat depression and other psychiatric disorders. This medication may increase the risk of suicidal thoughts or behaviors, especially in young individuals aged 18 to 24 years, and should be administered very cautiously under a physician's judgment in this age group. Additionally, this medication should not be given to patients with certain conditions. For example, patients allergic to this medication or its components, those with severe renal impairment, and those currently taking MAO inhibitors (another class of psychiatric drugs) should not use this medication. This medication should be used cautiously in patients with a history of seizures, as well as those at high risk for suicide or who exhibit manic symptoms. Patients with heart disease or ECG abnormalities such as QT interval prolongation may be at risk for cardiac arrhythmias from this medication, so an ECG test may be required before administering. Patients with liver or kidney dysfunction may be affected by this medication's metabolism and elimination, possibly necessitating dose adjustments. Diabetic patients should periodically monitor their blood glucose levels, as this medication may complicate blood sugar control. This medication can cause pupil dilation, requiring caution in patients who are at risk for increased intraocular pressure or glaucoma. Common side effects during treatment may include headache, nausea, insomnia, fatigue, and diarrhea, but more serious allergic reactions, liver function abnormalities, bleeding, or psychiatric symptoms can occur in rare instances. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, and tremors; therefore, a gradual reduction under a physician's guidance is recommended when stopping treatment. This medication can interact with other drugs, so if you are taking other medications, it is important to inform your doctor or pharmacist, particularly with caution when used alongside MAO inhibitors, serotonergic drugs, anticoagulants, or antipsychotics. Women who are pregnant or breastfeeding must consult a physician on the use of this medication and consider its potential effects on the fetus or newborn. This medication should generally not be used in children and adolescents as its safety and efficacy have not been sufficiently established. It should be administered cautiously to the elderly, who should be monitored closely for potential side effects considering any concurrent medical conditions or medications. This medication should be stored out of reach of children, and it is advisable not to transfer it to other containers. Finally, this medication may require caution in activities that necessitate attention, such as driving or operating machinery, so monitoring one's condition after taking it is necessary.

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 disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, trembling, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency to bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, voiding disorders, 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, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, anxiety, trembling, headache, anaphylactoid reaction, progressive systemic response, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behavior, hostility, Stevens-Johnson syndrome, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation 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 can be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This will help preserve the medication's efficacy over time.

Appearance and packaging

Appearance

A green capsule filled with white or grayish-white powder

Package unit

For domestic use - 30 capsules/bottle, For domestic use - 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.