Medication info
Oxygreen Capsule 10mg (Fluoxetine Hydrochloride)

Oxygreen Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Mothers Pharmaceutical Co., Ltd.
Appearance
A capsule with green upper and lower parts filled with white or grayish-white powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 202104514 · Approved 2021.06.11

Summary

Main use
Treatment of depressive and obsessive-compulsive disorders, 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. 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 must 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 medicine; however, psychopharmacologists recognize that acute episodes of depression require several months or more of drug therapy. 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 medicine per day. The daily dose must not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with concurrent illnesses: 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 When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, 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 medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. If a patient already taking this medicine requires urgent treatment with linezolid or intravenous methylene blue, and there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of patients with depression, and effects typically appear within 5 to 6 weeks. Depression is a condition characterized by persistent sadness accompanied by symptoms such as changes in appetite, sleep, psychomotor agitation, reduced interest, fatigue, feelings of guilt, decreased concentration, and suicidal thoughts. Additionally, it helps reduce binge-eating and purging behaviors in patients with bulimia nervosa. In obsessive-compulsive disorder, it reduces the symptoms of obsessions and compulsions, thereby alleviating difficulties in personal and professional social interactions. It is also effective for premenstrual dysphoric disorder and is used to improve emotional and physical symptoms that occur during the menstrual cycle. However, when used for long periods, it is important to regularly evaluate its efficacy for each patient. This medication is used for 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. 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 must 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 medicine; however, psychopharmacologists recognize that acute episodes of depression require several months or more of drug therapy. 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 medicine per day. The daily dose must not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with concurrent illnesses: 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 When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, 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 medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. If a patient already taking this medicine requires urgent treatment with linezolid or intravenous methylene blue, and there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is an antidepressant used for the treatment of psychiatric disorders such as major depressive disorder. There may be an increased risk of suicidal thoughts or behaviors during treatment, particularly in children, adolescents, and young adults, so extreme caution is warranted. Patients with hypersensitivity to this medication or severe renal impairment, as well as those taking certain medications (MAO inhibitors), should not use this drug. Patients with a history of seizures or high suicide risk, and those exhibiting manic symptoms should use this medication cautiously, and patients with heart disease should undergo ECG testing. Patients with compromised liver or kidney function, diabetic patients, and those at risk for increased intraocular pressure also require caution. Common side effects of this drug may include headaches, nausea, insomnia, fatigue, diarrhea, etc., and serious allergic reactions, bleeding, liver dysfunction, and other adverse effects may occur rarely. Withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea may appear upon discontinuation of the drug, so it is crucial to taper off gradually according to a doctor's instructions. This medication may interact with other central nervous system drugs or anticoagulants, so inform your doctor of any other medications you are taking. During pregnancy, there may be potential risks to the fetus, so it should only be used when necessary, and caution is advised for nursing mothers as the medication may be transmitted through breast milk. Safety has not been established for children and adolescents, so use is not recommended. Elderly patients need to be cautious due to increased risk of side effects depending on other diseases or medications they may be taking. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, and immediate medical attention is required. This medicine should be kept out of reach of children and should not be transferred to other containers for safety. Additionally, care should be taken when driving or operating hazardous machinery, and it is advisable to avoid alcohol consumption.

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 disturbance, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, pathologic muscle spasms, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, 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, sweating, angioedema, petechiae, phototoxic reaction, 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, malaise, abnormal mood, feeling cold, feeling warm, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms (dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reactions, progressive systemic reactions, suicidal behavior, hostility, growth retardation, death, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, hyperprolactinemia, hypoglycemia, immune-mediated 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 may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

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