Fluoxetine Capsule 10 mg (Fluoxetine Hydrochloride)

Adult dosage

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 daily were administered. If no improvement is observed, a dose increase may be considered after several weeks. Doses exceeding 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of a sufficient antidepressant effect may be delayed until 4 weeks of treatment or longer. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this drug, but psychopharmacologists recognize that acute signs of depression require drug treatment for several months or longer. It is not known whether the amount of antidepressant required to relieve symptoms is the same as that required to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this drug daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this drug daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug daily. Reassess the need for continued treatment after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant diseases: Administer a lower dose or reduce the dosing frequency. 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 drug, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, treatment 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 stopped 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 comes first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks 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 are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication is primarily used as an antidepressant for psychiatric conditions such as depression. It may increase the risk of suicidal thoughts or behavior in young adults and adolescents aged 18 to 24. Therefore, careful judgment and continuous observation are necessary when administering it to patients in this age group. Patients with hypersensitivity, severe renal impairment, or those taking certain medications (MAO inhibitors) should not use this medication. Patients with a history of seizures should exercise caution when using this drug and discontinue it immediately if seizures occur or increase in frequency. Patients with suicidal tendencies or a history of mania should also use this medication cautiously and monitor changes in symptoms closely during treatment. Patients with cardiovascular diseases or impaired liver or kidney function should discuss with healthcare professionals before taking this medication, and an ECG may be necessary. Diabetic patients requiring blood sugar control should carefully monitor blood glucose levels while taking this medication. Patients at risk of increased intraocular pressure or acute glaucoma should also use caution with this medication. Common side effects include headaches, nausea, insomnia, fatigue, and diarrhea, while severe allergic reactions, liver dysfunction, and bleeding may occur rarely. Especially at the beginning of treatment or after dosage changes, mental changes such as suicidal thoughts or behavior, aggression, anxiety, and agitation may appear, so patients and their guardians should observe them closely. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremor. Therefore, it is essential to gradually reduce the dosage following medical advice. This medication may interact with other drugs, so inform healthcare professionals if taking other medications, especially MAO inhibitors, serotonin-acting drugs, anticoagulants, and antiarrhythmics. During pregnancy, it should only be used if necessary, considering the potential risks to the fetus, and caution should be exercised during breastfeeding due to the possibility of drug transfer through breast milk. Safety in children and adolescents has not been sufficiently established and is generally not recommended. Elderly patients also require special attention, and in cases of overdose, serious side effects may occur, necessitating immediate medical attention. This medication should be kept out of reach of children and not transferred to other containers for safety.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, abnormal thoughts, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal ideation and behavior, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, dystonia, ataxia, balance disorders, myoclonus, seizures, inability to sit still, 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, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myalgia, 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, dizziness, sensory disturbances, sleep disturbances, asthenia, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic response, severe skin, kidney, liver or pulmonary-related reactions, suicidal thoughts, suicidal behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, dyskinesia, 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

This medication should be stored in a tightly closed container to prevent air exposure, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage maintains the effectiveness and prevents deterioration of the drug.

Appearance

A hard capsule with a green upper and lower part filled with white or grayish-white powder

Package unit

30 capsules/bottle, 500 capsules/bottle