Medication info
Unizac Capsule 10 mg (Fluoxetine Hydrochloride)

Unizac Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
Hard capsule with green upper and lower parts filled with white or grayish-white powder
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 201907012 · Approved 2019.10.01

Summary

Main use
Treatment of depression, obsessive-compulsive disorder, premenstrual dysphoric disorder, and bulimia nervosa
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 daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily must not be exceeded. 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 medicine, but psychopharmacologists recognize that acute symptoms 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 60mg of this medicine daily. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from 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 for treatment of a psychiatric disorder, at least 5 weeks must have elapsed since discontinuation of this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must 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 or other interventions, consider treatment. If urgent administration of linezolid or intravenous methylene blue is necessary in a patient already receiving this medicine, 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 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 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 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
Unimed Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication shows effects in treating depressive patients within 5-6 weeks, mainly improving symptoms related to persistent sadness. It also helps reduce binge-eating and bowel behavior in patients with bulimia nervosa. For patients with obsessive-compulsive disorder, it alleviates obsessive symptoms, reducing suffering in social or work life. It is also used to alleviate emotional symptoms such as depression and anxiety, as well as physical discomfort in patients with premenstrual dysphoric disorder. However, the effectiveness in long-term use needs to be regularly assessed on a patient-by-patient basis. This medication is indicated for the diseases mentioned above.

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 daily were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily must not be exceeded. 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 medicine, but psychopharmacologists recognize that acute symptoms 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 60mg of this medicine daily. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess the need for continued treatment after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, elderly patients, and patients with comorbid illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from 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 for treatment of a psychiatric disorder, at least 5 weeks must have elapsed since discontinuation of this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must 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 or other interventions, consider treatment. If urgent administration of linezolid or intravenous methylene blue is necessary in a patient already receiving this medicine, 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 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 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 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 primarily used to treat mental health issues such as depression. When using this medication, there may be an increased risk of suicidal thoughts or behavior, so close monitoring by a physician is necessary, especially for younger patients aged 18 to 24. Patients allergic to this medication or those with severe renal impairment, as well as those taking certain types of medications (MAO inhibitors), should not use it. Patients with a history of seizures should use this medication with caution, and treatment should be immediately discontinued if seizures worsen. This medication can affect heart rhythm, so caution is advised for patients with heart disease or abnormal results on ECG tests. Patients with liver or kidney impairment should have their dose adjusted, and diabetic patients may need to be cautious due to potential changes in blood sugar control. Side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur with this medication. During treatment, do not suddenly discontinue the medication; gradually reduce the dose as directed by a physician to prevent withdrawal symptoms. Moreover, this medication can interact with other drugs, so it is necessary to inform the physician or pharmacist of any concurrent medications. Pregnant or breastfeeding women should consult their doctor before taking this medication as it may affect the fetus or newborn. Its safety and efficacy in children and adolescents have not been established, so its use is not recommended in these populations. Elderly patients should use it cautiously as the risk of side effects may vary depending on other illnesses or medications taken.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, unusual dreams, depersonalization, elevated mood, euphoric mood, disordered thinking, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention disorders, dizziness, taste disturbances, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disturbances, tics, cramps, inability to maintain a sitting position, Buccglosal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, respiratory events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency to bruise easily, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, restless mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal hemorrhage, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, anxiety, tremor, headache, anaphylactoid reactions, gradual systemic reactions, suicidal thoughts, suicidal behaviors, 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, hyperprolactinemia, hypoglycemia, immune-mediated hemolytic anemia, renal failure, movement disorders, 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 that is not exposed to air and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Hard capsule with green upper and lower parts 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.