Medication info
Flumin Capsule 10 mg (Fluoxetine Hydrochloride)

Flumin Capsule 10 mg (Fluoxetine Hydrochloride)

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

MFDS item code 201503320 · Approved 2015.05.29

Summary

Main use
Treatment of mood disorders (depression, premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
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, a dose increase may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (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 the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, 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 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately 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 psychiatric disorders and starting treatment with this medicine. Conversely, at least 5 weeks should elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should 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, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome for 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 for 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 risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

Ingredients

Manufacturer
TaeGeuk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to improve the depressed mood and various accompanying symptoms in patients with depression. Symptoms of depression can include changes in appetite, sleep problems, decreased concentration, and increased fatigue; this medication is effective in alleviating these symptoms. It also helps reduce binge eating and purging behavior in cases of bulimia nervosa. In obsessive-compulsive disorders, it reduces compulsive behaviors and thoughts, alleviating difficulties in social and work life. For patients with premenstrual dysphoric disorder, it helps relieve cyclic discomfort such as depression, anxiety, and physical symptoms. Regular evaluation by a physician is necessary for long-term use, but overall, it is used to improve these symptoms.

Dosage and Administration

Adult dosage

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, a dose increase may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (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 the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine, 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 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately 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 psychiatric disorders and starting treatment with this medicine. Conversely, at least 5 weeks should elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should 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, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome for 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 for 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 risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

Precautions

This medication is used for the treatment of depression and other psychiatric disorders, and it should be used with great caution in children, adolescents, and young adults as it may increase the risk of suicidal thoughts or behavior. It should not be administered to patients with hypersensitivity or severe kidney impairment, and those already taking certain antidepressants should avoid its use. Patients with a history of seizures need to be careful when using this medication, and those at risk of suicide should be closely monitored, especially during the initial treatment and when changing doses. Patients with heart disease or liver and kidney function issues should also exercise caution when taking this medication; diabetics may need management for potential impacts on blood sugar control. This drug may have various side effects, with common symptoms including headaches, nausea, insomnia, fatigue, and diarrhea. Rarely, severe allergic reactions, bleeding, liver function abnormalities, and cardiac arrhythmias may occur, so any unusual symptoms should prompt immediate consultation with a physician. When discontinuing the treatment, withdrawal symptoms may arise, so the dosage should be gradually reduced according to a physician's direction, and abrupt cessation should be avoided. This medication may pose risks to a fetus during pregnancy and should only be used when absolutely necessary. Nursing mothers should either discontinue breastfeeding or consult a physician. Moreover, this medication may interact with other drugs, so it is crucial to inform the physician about any concurrent medications, and alcohol consumption should be avoided. Caution is required when operating vehicles or machinery, as this medication may affect judgment and motor skills. It is advised against use in children and adolescents due to insufficient evidence of safety and efficacy. While no specific adverse reactions have been reported in the elderly, caution is necessary based on other health conditions or concurrent medications. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac issues may occur, requiring immediate medical attention. Finally, it is critical to store this medication out of reach of children and not transfer it to other containers.

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, feelings of happiness, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, abnormal taste, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic clonic seizures, cramps, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleed, 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, photodermatitis, 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 disorders, weakness, restlessness, anxiety, tremor, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, kidney, liver or pulmonary-related reactions, suicidal thoughts, suicidal behavior, mania and hypomania, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with a green upper and lower part containing a white or 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.