Medication info
Rioxin Capsule 10mg (Fluoxetine Hydrochloride)

Rioxin Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
A capsule with green upper and lower parts filled with white or grayish powder
Packaging
30 capsules/bottle, 200 capsules/bottle
Approval status
Active

MFDS item code 202000390 · Approved 2020.01.23 · Insurance code 628901500

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

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or retardation of psychomotor activity
  • loss of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • impaired concentration
  • suicide attempts
View approved original text

This medication is effective in treating patients with major depressive disorder, typically showing improvement within 5 to 6 weeks. Depression is accompanied by persistent feelings of sadness or discomfort, changes in appetite and sleep, psychomotor changes, increased fatigue, feelings of guilt, impaired concentration, and thoughts of suicide. Additionally, in cases of binge eating disorder, it reduces binge eating and purging behaviors, alleviates symptoms of obsessive-compulsive disorders, and eases difficulties in daily life. It also helps improve depressive, anxious, and physical symptoms of premenstrual dysphoric disorder. This medication should be used with regular assessment of the patient's condition during long-term treatment. Overall, this medication is used to treat depression, binge eating disorder, obsessive-compulsion, and premenstrual symptoms.

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 medication is an antidepressant used to treat psychiatric disorders such as depression. During treatment with this medication, particularly in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors, so doctors should carefully consider the need for treatment and its risks. This medication should not be used in certain patients, such as those with allergies to this medication or its additives, patients with severe renal impairment, or patients taking MAO inhibitors. Patients with a history of seizures or those at high risk of suicide should exercise caution when using this medication and should consult a doctor immediately if symptoms worsen or new symptoms appear. This medication can affect the heart, so patients with heart disease or at risk for QT interval prolongation may need an electrocardiogram before taking it. Patients with impaired liver or kidney function may require dose adjustments, and diabetic patients should closely monitor their blood sugar control. This medication can cause pupil dilation, so patients at risk for glaucoma should be cautious, and those with allergies to certain coloring agents should also be careful. Common side effects may include headache, nausea, insomnia, fatigue, and diarrhea, and rarely may serious allergic reactions, bleeding, or hepatitis occur. Abruptly stopping this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and headaches, so dosages should be tapered gradually. During pregnancy, the risks to the fetus and the benefits of treatment should be carefully considered, and if breastfeeding, consultation with a doctor is necessary as this medication may pass into breast milk. This medication has not been sufficiently evaluated for safety and efficacy in children and adolescents, so its use is not recommended. Elderly patients may face an increased risk of side effects depending on other illnesses or medications, so caution is advised. Taking this medication in excess may lead to serious symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias, requiring immediate medical attention. Patients should avoid alcohol while taking this medication and consult their doctor or pharmacist regarding potential drug interactions. When driving or operating dangerous machinery, this medication may affect judgment or motor function, so caution is advised. Patients taking this medication and their caregivers should closely observe for signs of suicidal thoughts, behavioral changes, or aggression, and report any abnormalities to healthcare professionals immediately.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, reduced libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, feeling happy, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, motor abnormalities, ataxia, balance disorders, myoclonus, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, prolonged QT interval, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myalgia, dysuria, pain during urination, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, increased suicidal tendencies, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, lethargy, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, renal, hepatic or pulmonary reactions, growth delay, delayed puberty, Stevens-Johnson syndrome, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, 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 prevent exposure to air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

A capsule with green upper and lower parts filled with white or grayish 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.