Youngjin Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

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 the 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 or longer after the start of treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug. 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 the amount needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is needed. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate 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 drug, 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 have elapsed after discontinuing this drug. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization, other interventions should be considered. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this drug, and there is no alternative to linezolid or intravenous methylene blue 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 drug 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 drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection) or intravenous administration of this drug 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.

This medication is primarily used to treat psychiatric disorders such as depression. It may increase the risk of suicidal thoughts or behaviors, especially in younger individuals aged 18 to 24; therefore, the prescribing physician should carefully assess whether to prescribe it in this age group. Also, this medication should not be used in certain patients, such as those with allergies to this medication or its additives, severe renal dysfunction, or those taking certain types of medications known as MAO inhibitors. Patients with a history of seizures or high risk of suicide, patients exhibiting manic symptoms, those with heart diseases, and patients with impaired liver or kidney function, diabetes, and those at risk of glaucoma should use this medication with special caution. Common side effects may include headache, nausea, insomnia, fatigue, and diarrhea, while serious side effects such as allergic reactions, cardiac arrhythmias, bleeding, and skin rashes can occur infrequently. Especially, if this medication is stopped suddenly, withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, and anxiety can occur; therefore, it should be tapered off according to a doctor’s instructions. This medication may interact with other drugs, so it is essential to consult with a physician if taking any other medications or consuming alcohol. Pregnant or breastfeeding women should discuss the potential risks to the fetus or infant with their physician before taking this medication. For children and adolescents, safety and efficacy of this medication have not been established, so it is recommended to avoid use unless necessary. Elderly patients do not show specific adverse reactions, but caution is necessary depending on other diseases or ongoing medications. Finally, during the time of taking this medication or when changing doses, careful observation for any symptoms such as suicidal thoughts, changes in behavior, or seizures should be conducted, and if any abnormal symptoms occur, the physician should be consulted immediately.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, convulsions, akathisia, 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, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremor, headache, anaphylactoid reaction, progressive systemic reaction, severe skin, kidney, liver or lung-related reactions, suicidal ideation, suicidal behavior, hostility, Stevens-Johnson syndrome, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic 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

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius. This ensures the medication’s effectiveness is preserved.

Appearance

A hard capsule filled with a white to off-white powder, with green upper and lower parts.

Package unit

30 capsules/bottle, 300 capsules/bottle