Medication info
Frikdin Capsule (Fluoxetine Hydrochloride)

Frikdin Capsule (Fluoxetine Hydrochloride)

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

MFDS item code 200400952 · Notified 2004.09.30

Summary

Main use
Treatment of depression, obsessive-compulsive disorder, premenstrual dysphoric disorder, and bulimia nervosa
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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg 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, but 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 remission. 2. Bulimia nervosa Administer 60 mg of this drug per day. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60 mg of this drug per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug per day. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: 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 Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat a psychiatric disorder. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventional procedures, treatment 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, in 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 the patient for symptoms of serotonin syndrome for 5 weeks after linezolid or intravenous methylene blue administration, 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 nonintravenous 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 these uses.

Ingredients

Manufacturer
Aprogen Biologics Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • restlessness or lethargy
  • 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 primarily used for depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. Patients with depression show improvement in symptoms within 5-6 weeks, alleviating various symptoms such as persistent sadness, changes in appetite and sleep, and fatigue. It helps reduce binge eating and purging behaviors in patients with bulimia nervosa. Symptoms of obsessive-compulsive disorder are also significantly reduced, relieving the burden of social and work life for the patient. It alleviates premenstrual dysphoria symptoms, such as depression, anxiety, and physical pain, thereby improving the quality of daily life. It is essential to regularly reevaluate the effectiveness during long-term administration, as this medication is used to improve these symptoms overall.

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 per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg 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, but 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 remission. 2. Bulimia nervosa Administer 60 mg of this drug per day. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60 mg of this drug per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug per day. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: 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 Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat a psychiatric disorder. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventional procedures, treatment 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, in 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 the patient for symptoms of serotonin syndrome for 5 weeks after linezolid or intravenous methylene blue administration, 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 nonintravenous 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 these uses.

Precautions

This medication is an antidepressant used to treat psychiatric disorders such as major depression. There may be an increased risk of suicidal thoughts or behaviors during treatment, especially in children, adolescents, and young adults aged 18-24, thus requiring careful monitoring by healthcare providers. The medication should not be used in certain patients, such as those with allergies to this medication or its components, severe renal dysfunction, or those currently taking MAO inhibitors. Patients with a history of seizures should be cautious when using this medication, and treatment should be discontinued immediately if seizures occur or their frequency increases. This medication may affect the cardiovascular system; therefore, patients with heart disease should undergo an electrocardiogram before use, and discontinue immediately if arrhythmic symptoms appear. Patients with liver or kidney dysfunction require dose adjustments, and diabetic patients should be cautious, as blood sugar regulation may change. This medication may cause pupil dilation and should be used with caution in patients at risk of increased intraocular pressure or glaucoma. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, though rare allergic reactions or severe skin conditions may occur. Discontinuing this medication suddenly may result in withdrawal symptoms such as dizziness, anxiety, and tremors; hence, dosage should be gradually reduced under a doctor's guidance. It is advisable to avoid alcohol consumption during treatment, and interactions may occur with other medications, so consultation with a physician or pharmacist is necessary. During pregnancy, there is a risk to the fetus, so it should be used only when critically necessary; caution is also advised during breastfeeding as the drug may be passed through breast milk. Safety use in children and adolescents has not been established and is not recommended. Elderly patients may have an increased risk of side effects depending on other conditions or medications they are taking, necessitating caution. In cases of overdose, symptoms such as nausea, vomiting, seizures, and heart arrhythmias may occur, requiring immediate medical attention. This medication should be kept out of reach of children, and transferring to another container is not advisable for maintaining quality.

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 disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disturbances, dizziness, taste disturbance, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, periodic muscle spasms, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency to bruise, cold sweats, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, polyuria, dysuria, urinary retention, urination disorders, pelvic bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, nervous mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, rash, anaphylactoid reaction, gradual systemic reactions, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, 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 should be stored in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is between 1 to 30 degrees Celsius. Proper storage will ensure the medication's efficacy is maintained safely.

Appearance and packaging

Appearance

A hard capsule with green upper and pale yellow lower parts filled with a white to grayish 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.