Danatec Capsule (Fluoxetine Hydrochloride)

Adult dosage

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 20～80mg 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 or longer after starting 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 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 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. 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 diseases: Administer a low dose or reduce the dosing frequency. Adjust the dose as appropriate according to age and symptoms. - Switching from an MAO inhibitor used to treat psychiatric disorders Allow an interval of at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug 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 drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for a psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 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 for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be resumed 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 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 should be used cautiously in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, as there is an increased risk of suicidal thoughts or actions. This medication should not be administered to specific patients, such as those allergic to this medication or its excipients, those with severe renal impairment, and those taking MAO inhibitors. Patients with a history of seizures should use this medication with caution, and treatment should be discontinued immediately if seizures occur or increase in frequency. Patients with suicidal tendencies or a history of mania also require careful observation when using this medication. Patients with heart diseases or at risk for QT interval prolongation should have an ECG performed before administering this medication and should be closely monitored for cardiac status during treatment. Patients with impaired liver or renal function should have their dosage adjusted or should use this medication with caution. Diabetic patients should frequently check their blood glucose levels. This medication may cause pupil dilation, so patients with high intraocular pressure or at risk for glaucoma should be cautious. While taking this medication, various side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur and, if symptoms persist or worsen, patients should consult a doctor. This medication may cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, tremors, headaches, etc., if suddenly discontinued; therefore, the dosage should be gradually reduced according to a doctor's instructions. There is a risk of interactions when taking this medication with other drugs, especially MAO inhibitors, other antidepressants, or medications affecting coagulation, so healthcare providers should be informed. Pregnant or breastfeeding women should consult a doctor before taking this medication as it may affect the fetus or neonate. Safety and efficacy in children and adolescents have not been sufficiently established, so use is not recommended. Elderly people may be at increased risk of side effects depending on other conditions or medications, so caution is advised. In case of overdose, severe symptoms such as nausea, vomiting, seizures, and cardiac abnormalities may occur, and immediate medical attention should be sought.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylaxis, serum sickness, inappropriate secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorders, sexual dysfunction, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disturbances, clonic spasms, seizures, akathisia, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, 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, phototoxic reactions, purpura, erythema multiforme, arthralgia, myalgia, frequency of urination, dysuria, urinary retention, voiding dysfunction, 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, suicidal thoughts, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremor, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, reactions related to the kidneys, liver, or lungs, behaviors associated with suicide, hostility, growth delay, delayed puberty, withdrawal symptoms, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, 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 movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, seizures, asymptomatic arrhythmias, electrocardiogram changes, cardiac arrest, coma, CNS status changes

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. This will help preserve the effectiveness of the medication for a longer time.

Appearance

Capsule with upper green and lower light yellow containing white to pale gray powder

Package unit

30 capsules/bottle, 200 capsules/bottle