Medication info
Seletin Capsule 10 mg (Fluoxetine Hydrochloride)

Seletin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Bainex Co., Ltd.
Appearance
A hard capsule with a green upper and lower part filled with white or grayish-white powder.
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 200500622 · Notified 2005.08.29 · Insurance code 643101250

Summary

Main use
Treatment of 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 used. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be given in 2 divided doses (morning and noon), and the maximum dose of 80mg per day must not be exceeded. The onset of adequate antidepressant effects 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 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 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with concomitant diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from or to 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 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 administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome in a particular patient, this medicine 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 until 24 hours after the last dose, whichever comes 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 nonintravenous routes (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 these uses.

Ingredients

Manufacturer
Bainex Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • psychomotor agitation
  • psychomotor retardation
  • lack of interest in daily activities
  • decreased sexual desire
  • increased fatigue
  • guilt
  • feelings of worthlessness
  • slowed thought processes
  • decreased concentration
View approved original text

This medication shows effects in the treatment of depression within 5 to 6 weeks and improves symptoms in patients with persistent depressive states and various symptoms. It also helps reduce binge eating and purging behaviors in bulimia nervosa. The obsessions and compulsions in obsessive-compulsive disorder are alleviated, mitigating their negative impacts on social life. In premenstrual dysphoric disorder, it reduces depression, anxiety, and physical symptoms, relieving the burden on daily life. These effects appear within a certain period, and the efficacy should be evaluated regularly for each patient during long-term treatment. This medication is effectively used for the improvement of various psychiatric and physical symptoms.

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 used. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be given in 2 divided doses (morning and noon), and the maximum dose of 80mg per day must not be exceeded. The onset of adequate antidepressant effects 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 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 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with concomitant diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from or to 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 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 administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome in a particular patient, this medicine 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 until 24 hours after the last dose, whichever comes 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 nonintravenous routes (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 these uses.

Precautions

This medication is an antidepressant mainly used to treat psychiatric conditions such as depression. This medication may increase the risk of suicidal ideation or behaviors particularly in children, adolescents, and young adults aged 18 to 24; therefore, healthcare providers should carefully evaluate the risks and benefits when prescribing to this age group. All patients receiving this medication should be closely monitored for abnormal behavioral changes such as suicidal tendencies, aggression, and anger at the beginning of treatment and during dosage adjustments, and family members or caregivers should closely observe the patient and consult a physician promptly if any unusual symptoms occur. This medication should not be administered to specific patients, such as those with allergic reactions to this drug or its components, severe kidney disease, or those taking MAO inhibitors, as it can be dangerous. Additionally, patients with a history of seizures, high risk of suicide, manic symptoms, heart disease, diminished liver or kidney function, or diabetes may require special attention when taking this medication. Common side effects may include headaches, nausea, insomnia, fatigue, and diarrhea; rarely, serious allergic reactions, blood abnormalities, or liver dysfunction have been reported. Upon discontinuation of treatment, withdrawal symptoms such as dizziness, sensory disturbances, anxiety, nausea, and tremors may occur, so dosage should be gradually reduced under a physician's guidance. This medication can affect the fetus during pregnancy, thus careful use should be discussed with a healthcare provider during pregnancy; likewise, it may pass into breast milk, necessitating caution during lactation. Moreover, this medication may interact with other drugs, so individuals taking or planning to take other medications should consult their doctor or pharmacist. While taking this medication, judgment and motor function may be affected, necessitating caution when driving or operating dangerous machinery. Finally, this medication should be stored out of reach of children, and transferring it to another container can compromise its quality, so precautions should be taken.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, abnormal sexual desire, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, headache, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, convulsions, inability to sit still, 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, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reaction, purpura, erythema multiforme, arthralgia, myopathy, myalgia, frequent urination, dysuria, urinary retention, voiding disorders, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, nausea, vomiting, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe reactions related to the skin, kidneys, liver, or lungs, suicidal ideation, suicidal behaviors, mania, hypomania, suicidal tendencies, 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, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, inability to sit still, anxiety, agitation, panic disorder, excitement, hostility, aggression, impulsivity, convulsions, restlessness, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding from the skin, vaginal bleeding, gastrointestinal bleeding, mucosal bleeding

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 air exposure and kept at room temperature between 1 to 30 degrees Celsius. This method of storage helps maintain the medication's effectiveness for a prolonged period.

Appearance and packaging

Appearance

A hard capsule with a green upper and lower part filled with white or grayish-white powder.

Package unit

30 capsules/bottle, 500 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.