Medication info
Slicetin Capsule (Fluoxetine Hydrochloride)

Slicetin Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Dongkuk Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a green upper part and a pale yellow lower part filled with a grayish-white powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201802049 · Approved 2018.05.14 · Insurance code 653404020

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
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 should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks of treatment or longer. 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 pharmacotherapy 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 levels 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 necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower 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 When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. 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. If a patient already receiving this medicine needs urgent treatment with linezolid or intravenous methylene blue, and no alternative to linezolid or intravenous methylene blue is available, 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 medicine may be stopped 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 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 non-intravenous routes (oral tablets or local injection) or with 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
Dongkuk Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used for the treatment of depression, which is accompanied by various symptoms including changes in appetite, sleep disorders, lack of motivation, fatigue, feelings of guilt, and decreased concentration. It is also effective in reducing binge eating and laxative behavior in patients with bulimia nervosa. For patients with obsessive-compulsive disorder, it plays a role in alleviating obsessive-related symptoms, positively impacting the patient's social life. Furthermore, it helps improve symptoms such as depression, anxiety, and physical pain associated with premenstrual dysphoric disorder. However, continuous evaluation by a doctor is necessary with long-term use. In summary, this medication is used for the treatment of 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 should not be exceeded. The onset of an adequate antidepressant effect may be delayed until 4 weeks of treatment or longer. 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 pharmacotherapy 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 levels 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 necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower 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 When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. 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. If a patient already receiving this medicine needs urgent treatment with linezolid or intravenous methylene blue, and no alternative to linezolid or intravenous methylene blue is available, 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 medicine may be stopped 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 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 non-intravenous routes (oral tablets or local injection) or with 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 an antidepressant primarily used to improve symptoms associated with depression. There may be an increased risk of suicidal thoughts or behavior in children, adolescents, and young adults aged 18 to 24, so caution should be exercised when prescribing this age group. Patients with a history of hypersensitivity, severe renal dysfunction, or those taking certain types of medications (MAO inhibitors) should not take this medication. Patients with a history of seizures should take this medication with particular caution, and if seizures occur or increase in frequency, the treatment should be discontinued. Patients at risk of suicide should be closely monitored for changes in symptoms or signs of suicidal thoughts from the beginning of treatment, and family members or guardians should also observe the patient carefully. Patients with heart disease or those with abnormal electrocardiograms should undergo ECG testing before treatment and consult a doctor immediately if cardiac symptoms occur during treatment. Patients with impaired liver or renal function may require dosage adjustments, and diabetic patients may need close monitoring for blood sugar control. This medication can cause pupil dilation, so patients at risk for increased intraocular pressure or glaucoma should use it cautiously. Side effects such as headaches, nausea, insomnia, fatigue, and diarrhea are common during treatment, while serious allergic reactions or skin rashes, bleeding, and changes in mental state can occur infrequently. When discontinuing treatment, do not stop abruptly; tapering the dose gradually is necessary, as withdrawal symptoms such as dizziness, anxiety, and headache may arise. This medication may interact with other drugs, so it is essential to consult a doctor if taking other medications or planning to consume alcohol. During pregnancy, it should be used cautiously considering the risk to the fetus and the benefits of treatment; during breastfeeding, caution is also advised as the medication may be transmitted through breast milk. While no specific adverse reactions have been reported in the elderly, caution is warranted based on comorbid conditions or concurrent medications. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, necessitating immediate medical attention, and there is no specific antidote. This medication should be stored out of the reach of children, and transferring it to another container is discouraged as it can negatively affect quality.

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 disorder, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, motor disturbances, ataxia, balance disorders, tonic-clonic seizures, convulsions, inability to remain seated, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency to bruise, diaphoresis, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased frequency of urination, 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, dizziness, sensory disturbances, sleep disorders, weakness, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reaction, suicidal ideation, suicidal behavior, increased risk of fractures, withdrawal symptoms, rash, allergic symptoms, hypoglycemia, platelet function changes, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation of motor disturbances, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, inability to remain seated, psychomotor restlessness

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid very hot or very cold places, and store at room temperature between 1 degree and 30 degrees Celsius for safety.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a pale yellow lower part filled with a 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.