Arozac 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 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 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 generally recognize that acute episodes of depression require medication treatment for several months or longer. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that 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 levels 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 necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with concomitant illnesses: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this product, an interval of at least 14 days must be allowed. Conversely, at least 5 weeks must elapse after discontinuing this product 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 product 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 product. If no alternative to linezolid or intravenous methylene blue is available 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 product may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this product may be restarted 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 with intravenous administration of this product 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 may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; hence, careful assessment of risks and benefits is required by physicians when administering it to patients in this age group. All patients taking this medication should be monitored closely for abnormal behaviors such as suicidal thoughts, behavior changes, aggression, and anger after starting treatment or changing doses. Families or caregivers should also observe for any abnormalities and consult healthcare professionals immediately if noticed. This medication is contraindicated in specific patients, such as those allergic to this drug or any of its components, patients with severe renal impairment, those currently taking MAO inhibitors, and patients with genetic issues like lactose intolerance. Patients with a history of seizures or high suicide risk, those with bipolar disorder, heart disease, or renal or hepatic dysfunction, diabetics, and patients at increased risk of intraocular pressure should exercise particular caution when using this medication. This medication can cause various side effects including headaches, nausea, insomnia, fatigue, diarrhea, etc., and in rare cases, serious adverse reactions that may include severe allergic reactions, hepatitis, skin rashes, bleeding, and arrhythmias. Abrupt discontinuation of this medication can cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, nausea, tremors, and headaches; therefore, it should be gradually reduced under medical supervision. This medication may interact with other drugs; hence, it is crucial to consult with a physician or pharmacist if taking or planning to take other medicines, and alcohol consumption is not recommended. During pregnancy, there may be risks to the fetus, so it should only be administered under the physician's discretion, and care should be taken during breastfeeding as it may be excreted in breast milk and negatively affect the baby. This medication's safety and efficacy have not been adequately demonstrated in children and adolescents, so it is preferable to avoid prescribing it whenever possible. Although no specific adverse reactions have been reported in the elderly, caution is still advised based on other health conditions or medications they may be taking. In cases of overdose, severe symptoms such as nausea, vomiting, seizures, arrhythmias, and coma may occur, requiring immediate emergency treatment, and there is no specific antidote, so symptomatic treatment is essential. This medication must 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, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor hyperactivity, movement disorders, ataxia, balance disorders, tonic-clonic seizures, spasms, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, itching, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, phototoxic reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary disturbances, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, cold sensation, hot sensation, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, reactions related to kidneys, liver or lungs, suicidal ideation, suicidal behavior, hostility, mania, hypomania, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders, exacerbation of existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension

This medication should be stored in a tightly sealed container, protected from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Doing so helps maintain the medication's efficacy and safety for use.

Appearance

Green capsules filled with white or grayish powder

Package unit

30 capsules/bottle, 300 capsules/bottle