Medication info
Micetine Capsule 10 mg (Fluoxetine Hydrochloride)

Micetine Capsule 10 mg (Fluoxetine Hydrochloride)

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

MFDS item code 200502251 · Notified 2005.01.11

Summary

Main use
Treatment of psychiatric disorders (depression, 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 fluoxetine hydrochloride 20mg 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 2 times daily (morning and noon), and the maximum dose of 80mg 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 product, 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 the amount needed to maintain or sustain remission. 2. Bulimia nervosa Administer this product 60mg per day. Do not exceed 80mg per day. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer this product 20~60mg per day. Do not exceed 80mg per day. 4. Premenstrual dysphoric disorder Administer this product 20mg per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, 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 or to an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this product, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 weeks must elapse after discontinuing this product. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this product 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 product. If 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, this product may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient 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 product may be resumed 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 product at 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
Baskhan Bio Pharmaceuticals Co., Ltd.

Efficacy & effects

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

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

This medication helps improve the symptoms of patients with depression. Depression is often accompanied by various symptoms including persistent sadness, decreased appetite, sleep disturbances, psychomotor agitation, lack of interest, and decreased concentration. This drug shows relief of these symptoms within 5 to 6 weeks. It is also effective in reducing binge eating and purging behavior in patients with bulimia nervosa. In cases of obsessive-compulsive disorder, it reduces obsessive thoughts and behaviors, alleviating social and occupational distress. It helps relieve symptoms of depression, anxiety, and physical pain associated with premenstrual dysphoric disorder. However, the long-term effects of this medication should be regularly evaluated for each individual patient. This medication is used for depression, bulimia nervosa, obsessive-compulsive disorders, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 2 times daily (morning and noon), and the maximum dose of 80mg 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 product, 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 the amount needed to maintain or sustain remission. 2. Bulimia nervosa Administer this product 60mg per day. Do not exceed 80mg per day. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer this product 20~60mg per day. Do not exceed 80mg per day. 4. Premenstrual dysphoric disorder Administer this product 20mg per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, 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 or to an MAO inhibitor for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this product, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 weeks must elapse after discontinuing this product. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this product 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 product. If 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, this product may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient 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 product may be resumed 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 product at 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 mainly used to treat psychiatric disorders related to depression. It may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults aged 18 to 24, and therefore, physicians should carefully evaluate the risks and benefits when prescribing to patients in this age group. All patients taking this medication should be closely monitored for suicidal thoughts, aggression, irritability, or abnormal behavioral changes from the start of treatment, and family members or guardians should also carefully observe the patient and immediately inform the physician of any unusual symptoms. This medication should not be administered to certain patients, such as those allergic to this drug or its components, those with severe renal impairment, or those currently taking MAO inhibitors. Patients with a history of seizures should be especially cautious, and if seizures occur or their frequency increases, the medication should be discontinued. Patients with cardiac diseases or those at risk for QT interval prolongation should have their condition monitored through ECG while on this medication. Patients with impaired liver or kidney function should have their doses adjusted, and diabetic patients should periodically monitor their blood glucose, as this drug can affect blood sugar control. This medication may dilate pupils and requires caution in patients who have elevated intraocular pressure or are at risk for glaucoma. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, while rare side effects may include allergic reactions, cardiac arrhythmias, blood disorders, and skin rash. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, tremors, and headaches; therefore, the dosage should be gradually reduced under medical supervision. During pregnancy, it should only be used when necessary, considering its potential effects on the fetus; breastfeeding should also be discussed with a physician due to its excretion in breast milk. Safety and efficacy for children and adolescents have not been sufficiently established, therefore, use is not recommended. Older adults can generally use this medication, but caution is needed due to the risk of side effects depending on other conditions or medications. Additionally, this medication may interact with other drugs, so if any other medications are being taken, it is important to inform a physician or pharmacist, and alcohol consumption should be avoided. Finally, this medication may affect judgment and motor skills, so caution is advised when driving or operating hazardous machinery.

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 disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal thoughts and behavior, confusion, attention disorder, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, torsional myoclonus, convulsions, akathisia, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, hives, pruritus, sweating, increased tendency for bruising, cold sweats, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myalgia, increased urinary frequency, dysuria, urinary retention, micturition disorder, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms (dizziness, sensory disturbances, sleep disturbances, weakness, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reactions, gradual systemic reactions, severe skin, kidney, liver or pulmonary reactions, suicidal behavior, hostility, growth delay, decreased alkaline phosphatase levels, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic failure, hyperprolactinemia, hypoglycemia, immune-mediated hemolytic anemia, renal failure, worsening of dystonia, 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 closed container to protect it from air and moisture. Additionally, it should be kept in a cool and dry place, ideally at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A green hard capsule filled with white to 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.