Medication info
Riotin Capsule 20 mg (Fluoxetine Hydrochloride)

Riotin Capsule 20 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
Hard capsule with green upper part and light yellow lower part filled with white or grayish-white powder
Packaging
30 capsules/bottle, 200 capsules/bottle
Approval status
Active

MFDS item code 202000391 · Approved 2020.01.23 · Insurance code 628901510

Summary

Main use
Treatment of psychiatric disorders (depression and 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. Doses of 20~80mg daily were used in controlled clinical trials. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be given 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 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 symptoms of depression require medication for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 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, reevaluate whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. The dose may be adjusted according to age and symptoms. Switching from or to MAO inhibitors for the treatment of 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 for the treatment of 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 this drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 for 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 methylene blue administered by a non-intravenous route (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 acute symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • psychomotor agitation or retardation
  • lack of interest in daily activities or decreased sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowing of thought or decreased concentration
  • suicidal thoughts or attempts
  • binge eating
  • purging behavior
  • obsessions
View approved original text

This drug is used in the treatment of patients with depression and its effects appear within approximately 5-6 weeks. Depression is a condition that includes various symptoms such as persistent sadness, changes in appetite or sleep, increased fatigue, and decreased concentration. It also has an effect on reducing binge eating behavior in bulimia nervosa. It helps to alleviate obsessions and compulsions in patients with obsessive-compulsive disorder. It is also used to improve emotional and physical symptoms caused by premenstrual dysphoric disorder. However, it is important to periodically evaluate the patient's condition during long-term use. This drug is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, 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. Doses of 20~80mg daily were used in controlled clinical trials. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be given 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 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 symptoms of depression require medication for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 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, reevaluate whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. The dose may be adjusted according to age and symptoms. Switching from or to MAO inhibitors for the treatment of 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 for the treatment of 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 this drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization and other interventions, 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 for 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 methylene blue administered by a non-intravenous route (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 acute symptoms of serotonin syndrome with these uses.

Precautions

This drug is an antidepressant used to treat psychiatric conditions such as depression. This drug can particularly increase the risk of suicidal thoughts or behaviors in young people aged 18 to 24, so caution is advised when administering it to patients in this age group. This drug should not be used in patients with certain conditions, such as severe renal impairment or those taking monoamine oxidase inhibitors (MAOIs). Patients with a history of seizures should use this drug with caution, and if seizures increase, treatment should be discontinued immediately. This drug should also be administered with caution to patients with heart disease, liver or kidney dysfunction, or diabetes. While taking this drug, side effects such as headaches, nausea, insomnia, fatigue, and diarrhea can commonly occur, and rare serious side effects such as severe allergic reactions or cardiac arrhythmias may also occur. Particularly during the initial phase of treatment, depression symptoms may worsen or suicidal impulses may emerge, requiring patients and families to closely monitor for changes and consult healthcare professionals if abnormalities arise. Abruptly discontinuing this drug may result in withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors, so dosage should be gradually reduced as directed by a physician. Additionally, this drug may interact with other medications, so patients should inform healthcare providers about any other medications they are taking, and it is advisable to avoid alcohol consumption. Women who are pregnant or breastfeeding may affect the fetus or newborn when using this drug, so they should discuss it with their doctor before taking it. The use of this drug is not recommended for children and adolescents as its safety and effectiveness have not been adequately established. Special caution is needed for elderly patients, and it should be administered carefully considering other medical conditions or medications. Overdose of this drug can lead to serious side effects, so the prescribed dosage must be strictly followed. Finally, this drug should be stored out of reach of children and should not be transferred to other containers.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, neurosensitization, 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 impulses and behavior, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, muscular spasms, seizures, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleed, vomiting, dyspepsia, dry mouth, difficulty swallowing, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, diaphoresis, angioedema, purpura, phototoxic reaction, petechiae, erythema multiforme, arthralgia, muscle spasms, myalgia, frequent urination, dysuria, urinary retention, micturition dysfunction, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function values, suicidal thoughts, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, weakness, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, severe reactions related to skin, kidneys, liver, or lungs, weight loss, growth delay, decreased alkaline phosphatase levels, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, 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, akathisia, psychomotor agitation

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Hard capsule with green upper part and light yellow lower part filled with white or grayish-white powder

Package unit

30 capsules/bottle, 200 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.