Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 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 ∼ 80 mg daily were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses exceeding 20 mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80 mg daily should not be exceeded. The onset of adequate antidepressant effects 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 episodes 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 the dose needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60 mg of this drug daily. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20 ∼ 60 mg of this drug daily. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this drug daily. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple drugs, elderly patients, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions; therefore, it should be administered with caution in these age groups. This medication should not be administered to specific patients, such as those allergic to this medication or any of its excipients, those with severe renal impairment, and those taking MAO inhibitors. Patients with a history of seizures should use this medication with caution; if seizures occur or their frequency increases, treatment should be stopped immediately. This medication may be associated with exacerbation of symptoms or suicidal ideation in patients at risk of suicide; hence, patients and their guardians should be closely monitored during the initiation of treatment and when changing dosages. In patients with a history of mania or hypomania, this medication should be administered with caution, and discontinuation should occur if manic symptoms appear. Patients with heart disease or those at risk of QT interval prolongation should undergo ECG monitoring and be observed closely when using this medication. Patients with impaired liver or kidney function should have dosages adjusted, and diabetic patients should monitor their blood sugar levels closely. This medication can cause pupillary dilation; therefore, caution is needed in patients at risk of increased intraocular pressure or acute glaucoma. Common side effects during administration may include headaches, nausea, insomnia, fatigue, diarrhea, etc., and if any allergic reactions or serious adverse effects occur, medical advice should be sought immediately. If this medication is suddenly discontinued, withdrawal symptoms such as dizziness, sleep disturbances, anxiety, and nausea may arise; hence, it is recommended to gradually reduce the dosage before stopping. This medication can potentially lead to serotonin syndrome when used in conjunction with other serotonergic medications; therefore, particular caution is advised during concomitant use. During pregnancy, there may be potential risks to the fetus; therefore, pregnant women should consult a physician before using this medication, and caution is also needed while breastfeeding, as the drug may be excreted in breast milk. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, and use should be avoided in this age group. No specific adverse reactions have been reported in the elderly; however, caution is needed in patients taking other medications or having comorbid conditions. In cases of overdose, serious symptoms may occur, such as nausea, vomiting, seizures, and cardiac arrhythmias; thus, strict adherence to dosing guidelines is crucial, and medical institutions should be visited immediately in case of emergency. This medication should be stored out of reach of children and should not be transferred to other containers to maintain quality and safety.

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, feeling happy, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disorders, somnolence, drowsiness, tremors, psychomotor agitation, abnormal movement, ataxia, balance disorders, tonic-clonic spasm, seizures, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, clammy sweat, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculatory dysfunction, 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, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, exacerbation of pre-existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, inability to sit still, serotonin syndrome, bleeding, petechiae, purpura, abnormal bleeding of the skin

This medication should be stored in a sealed container to prevent air ingress and is safely stored at room temperature between 1 and 30 degrees Celsius. Proper storage allows for well-maintained effectiveness of the drug.

Appearance

A hard capsule with green upper and lower parts filled with white or grayish-white powder.

Package unit

30 capsules/bottle, 500 capsules/bottle