Fluoxetine Capsules 20mg (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: Administer an initial dose of 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 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, but psychopharmacologists recognize that acute episodes of depression require several months or more of drug treatment. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, and patients with concomitant diseases: Administer a lower dose or reduce the frequency of administration. The dose may be adjusted appropriately 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 medicine, 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 since discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of 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 medicine. 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 medicine 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 medicine may be resumed 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 with intravenous administration of this medicine 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 associated with depression. This medication may increase the risk of suicidal thoughts or suicide behavior, especially in young people aged 18 to 24, thus careful evaluation is necessary before administering it to patients in this age group. It should not be administered to certain patients, such as those allergic to this medication or its additives, patients with severe renal impairment, and patients currently taking MAO inhibitors. Special caution is advised for patients with a history of seizures, suicidal tendencies, mania, cardiovascular diseases, or decreased liver or kidney function. Diabetic patients should periodically check their blood glucose levels while on this medication, as it may affect glucose control, and treatment adjustments may be necessary. Various side effects such as insomnia, headache, nausea, fatigue, and diarrhea may occur, and serious adverse reactions, including severe allergic reactions and cardiac arrhythmias, have been reported rarely. Behavioral changes such as suicidal thoughts, aggression, anxiety, and nervousness may occur, especially at the beginning of treatment or during dosage adjustments, so patients and caregivers should monitor these closely. Discontinuing this medication abruptly may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to a doctor's instructions. This medication has a high potential for drug interactions, particularly when taken with MAO inhibitors, serotonin-active drugs, anticoagulants, and certain heart medications. During pregnancy, it should only be used if necessary due to potential risks to the fetus, and during breastfeeding, consideration should be given to discontinuing breastfeeding, as the medication can be transmitted through breast milk. It is recommended not to administer this medication to children and adolescents, as safety and efficacy have not been established. While no specific adverse reactions have been reported in the elderly, careful administration is necessary, considering other illnesses and medications. Excessive doses of this medication may lead to severe side effects, and immediate medical attention is required. Lastly, this medication should be kept out of the reach of children and should not be transferred to other containers.

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, feelings of happiness, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, spasms, inability to sit still, buccoglosal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related incidents, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, hair loss, tendency to bruise easily, diaphoresis, angioedema, petechial hemorrhage, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, urination 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, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reactions, severe skin, kidney, liver, or pulmonary-related reactions, suicidal ideation, suicidal behaviors, 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, movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

This medication may be sensitive to air and moisture, therefore it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer period.

Appearance

A hard capsule with a green upper and a yellowish lower part containing a white to grayish powder

Package unit

30 capsules/bottle, 200 capsules/bottle