Medication info

Flujak Capsule 10 Milligrams (Fluoxetine Hydrochloride)

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

MFDS item code 202002967 · Approved 2020.04.24

This product's status changed to Expired on 2025.04.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 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. The 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; however, psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as that needed to maintain or continue 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medicines, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the dosing frequency. Adjust the dose as appropriate according to age and symptoms. Switching from or to an MAO inhibitor used to treat 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 to treat psychiatric disorders, 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventions, consider treatment. If linezolid or intravenous methylene blue must be administered urgently to 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 for that 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 linezolid or intravenous methylene blue is administered, 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 methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medicine at doses 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
TheU Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Low mood
  • discomfort
  • changes in appetite
  • changes in sleep
  • agitation
  • retardation
  • lack of interest
  • decreased sexual desire
  • fatigue
  • feelings of guilt
  • feelings of worthlessness
  • cognitive slowing
View approved original text

This drug shows improvement in symptoms within 5 to 6 weeks for patients with depression. Depression is characterized by persistent low mood along with changes in appetite, sleep, and concentration. It also reduces binge eating and purging behaviors in patients with bulimia nervosa and alleviates the distress associated with obsessive-compulsive disorder symptoms. It helps alleviate emotional symptoms such as depression and anxiety, as well as physical discomfort in patients with premenstrual dysphoric disorder. However, in all cases, if used for longer than 5 to 6 weeks, the efficacy for each individual patient should be regularly assessed. This drug is used for treating 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 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. The 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; however, psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as that needed to maintain or continue 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. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medicines, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the dosing frequency. Adjust the dose as appropriate according to age and symptoms. Switching from or to an MAO inhibitor used to treat 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 to treat psychiatric disorders, 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 treatment for a more urgent psychiatric condition, including hospitalization or other interventions, consider treatment. If linezolid or intravenous methylene blue must be administered urgently to 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 for that 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 linezolid or intravenous methylene blue is administered, 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 methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous administration of this medicine at doses 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 drug may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; hence, careful assessment by a physician is required before administration. This drug should not be used in certain patients, such as those allergic to this drug or its additives, those with severe kidney impairment, and patients currently taking MAO inhibitors. Patients with a history of seizures require special caution when using this drug, and treatment should be immediately discontinued if seizures occur or frequency increases. Patients with suicidal thoughts or high suicide risk among those suffering from depression require close monitoring from the start of treatment, and family or caregivers should also closely observe the patient's condition. This drug should be used with caution in patients with a history of manic episodes or hypomania, and it should be discontinued if manic symptoms appear. Patients with heart disease or risk of prolonged QT interval should have an ECG performed before taking this drug and cardiac conditions should be carefully monitored during use. Patients with impaired liver or kidney function should have dosages adjusted, and diabetic patients should closely monitor their blood glucose levels. This drug can cause pupil dilation, which may pose a risk of increased intraocular pressure or glaucoma; caution is advised for such patients. Common side effects during use include headache, nausea, insomnia, fatigue, and diarrhea; severe allergic reactions or skin rashes should be reported to a doctor immediately. Long-term use of this drug may lead to metabolic abnormalities such as weight loss or hyponatremia, requiring regular check-ups. Abrupt discontinuation of treatment may lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so dosage should be gradually reduced according to the doctor's instructions. This drug has many potential interactions with other medications, so inform your doctor or pharmacist of any medications being taken, especially when used in combination with MAO inhibitors, anticoagulants, or central nervous system drugs. During pregnancy, the risks to the fetus should be considered, using this drug only when necessary; if breastfeeding, consideration should be given to the potential for this drug to be excreted in breast milk. Safety and efficacy in children and adolescents have not been established, so use is not recommended. Elderly patients may have an increased risk of adverse reactions due to other conditions or medications, so caution is required. In case of overdose, symptoms such as nausea, seizures, and cardiac arrhythmias may occur, necessitating immediate medical attention. This drug should be kept out of the reach of children, and changes to the container should be avoided. During treatment, judgment or motor functions may be affected, so caution should be used when driving or operating dangerous machinery.

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, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disorders, dizziness, taste disorders, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic muscle spasms, convulsions, inability to maintain a sitting position, Buccoglossal syndrome, serotonin syndrome, memory disorders, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased frequency of urination, dysuria, urinary retention, urinary disorders, 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, withdrawal symptoms (dizziness, sensory disturbances, sleep disorders, weakness, restlessness, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reactions, gradual systemic reactions, behaviors related to suicide, growth retardation, hypoglycemia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, 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 maintain a sitting position, anxiety, agitation, panic disorder, excitability, hostility, aggression, impulsivity, hypomania, mania

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

Storage

This drug should be stored in a tightly sealed container to prevent air ingress and kept at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

Hard capsules with green upper and lower parts filled with white or light gray 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.