Medication info
Slesetin Capsule 10 mg (Fluoxetine Hydrochloride)

Slesetin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Dongkuk Pharmaceutical Co., Ltd.
Appearance
Green hard capsule filled with white or grayish-white powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201805118 · Approved 2018.12.17 · Insurance code 653404710

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 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20–80 mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg per day should not be exceeded. The onset of 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, but psychopharmacologists recognize that acute depressive episodes 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60 mg of this medicine per day. Do not exceed a daily dose of 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg of this medicine per day. Do not exceed a daily dose of 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant diseases: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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 psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 weeks must elapse after discontinuing this medicine. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization, other interventional procedures should be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 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 medicine at a dose of 1 mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Dongkuk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat various psychiatric symptoms including depression. Effects typically appear in depression patients within about 5-6 weeks and help improve persistent depressive moods that cause impaired daily functions, as well as issues with appetite, sleep, psychomotor activity, concentration, feelings of guilt, and suicidal thoughts. It also reduces binge eating and purging behaviors in bulimia nervosa and alleviates the distress caused by obsessive thoughts and compulsive behaviors in obsessive-compulsive disorder. It is also used to improve symptoms of premenstrual dysphoric disorder including depression, anxiety, and physical discomfort. It is important to continue assessing individual patient responses to treatment after a certain period of administration. Therefore, 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 20 mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20–80 mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg per day should not be exceeded. The onset of 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, but psychopharmacologists recognize that acute depressive episodes 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60 mg of this medicine per day. Do not exceed a daily dose of 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg of this medicine per day. Do not exceed a daily dose of 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine per day. Reassess whether continued treatment is needed after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with concomitant diseases: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately 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 psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 weeks must elapse after discontinuing this medicine. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. In patients requiring more urgent treatment for a psychiatric condition, including hospitalization, other interventional procedures should be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. The patient should be monitored 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 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 medicine at a dose of 1 mg/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 used to treat psychiatric disorders such as major depression. However, it may increase the risk of suicidal thoughts or behaviors, especially in young people aged 18 to 24, so careful judgment by a physician is required when administering it to patients in this age group. This medication has not been approved for use in children and adolescents, and it is advisable not to use it. Patients with allergies to this medication, severe kidney impairment, or those taking certain types of medications (e.g., MAO inhibitors) should not take this medication. Patients with a history of seizures require special caution when taking this medication, and treatment should be immediately discontinued if seizures occur or worsen. Patients with suicidal thoughts or previous suicide attempts need to be monitored closely while taking this medication. Patients with heart disease, liver dysfunction, or renal impairment should consult a physician before taking this medication, and if necessary, an electrocardiogram or dosage adjustment may be required. Diabetic patients who require blood sugar control should carefully monitor changes in blood sugar while taking this medication, and dosage adjustments of insulin or hypoglycemic agents may be necessary. This medication can cause ophthalmic problems such as pupil dilation, so patients at risk for glaucoma should exercise caution. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, while serious allergic reactions, bleeding, and cardiac arrhythmias may occur rarely. Suddenly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, headaches, and nausea, so it is important to gradually taper off the dosage under a physician's guidance when discontinuing use. This medication may interact with other drugs, so it is essential to consult a physician, especially when taking it with MAO inhibitors, blood-thinning medications, or heart-affecting medications. During pregnancy, there is potential risk to the fetus, so it should only be taken when absolutely necessary, and similar caution applies during breastfeeding as this medication can be secreted into breast milk and affect the baby, hence consulting a specialist is essential. While taking this medication, care must be taken when driving or operating hazardous machinery, and alcohol consumption is not recommended. Keep out of reach of children, and do not arbitrarily discontinue or change the dosage.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormalities in antidiuretic hormone secretion, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, abnormal libido, teeth grinding, 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, tonic-clonic seizures, convulsions, akathisia, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, cold sweat, angioedema, petechiae, phototoxicity, purpura, erythema multiforme, arthralgia, myalgia, urinary frequency, dysuria, urinary retention, urinary dysfunction, 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, fractures, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, gradual systemic responses, severe reactions related to skin, kidneys, liver, or lungs, suicidal ideation, suicidal behavior, mania and hypomania, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, aggressive behavior, 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, hypoglycemia, immune-mediated hemolytic anemia, renal failure, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, vaginal bleeding, anxiety, agitation, panic disorder, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture ingress, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain its effectiveness and allow for safe use.

Appearance and packaging

Appearance

Green hard capsule 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.