Arojak Capsule 20 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 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 an adequate antidepressant effect may be delayed until 4 weeks or longer after treatment begins. 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 drug 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 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. Reassess the need for continued treatment after 6 months of treatment. 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 as appropriate 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 medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider administering it. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Patients should be monitored 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with intravenous administration of this medicine at doses 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 to treat psychiatric disorders related to depression. During treatment, particularly among young adults aged 18 to 24, there may be an increased risk of suicidal thoughts or behaviors, so careful monitoring by the physician and guardians is required. Patients with hypersensitivity, severe renal impairment, or those taking certain medications such as MAO inhibitors should not use this medication. Patients with a history of seizures need to use this medication cautiously, and if seizures occur or increase in frequency, treatment should be stopped immediately. This medication can affect the heart, so patients with heart disease or ECG abnormalities such as QT interval prolongation require careful monitoring by a physician. Dose adjustments may be necessary for patients with impaired liver or kidney function. Diabetic patients should monitor their blood sugar periodically as there may be changes in blood glucose control. The medication may cause pupil dilation, so patients at risk of increased intraocular pressure or glaucoma should be cautious. Common side effects during the treatment may include headache, nausea, insomnia, fatigue, and diarrhea, while rare cases of allergic reactions or serious skin disorders may occur. Abrupt discontinuation of this medication can result in withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so it should be gradually reduced under a physician's guidance. Interactions may occur with other medications, so patients must inform their physician or pharmacist of any other medications they are taking, and it is advisable to avoid alcohol consumption. If pregnant or breastfeeding, consultation with a physician is essential as this medication may affect the fetus or newborn. Safety and efficacy in children and adolescents have not been well established, so its use is not recommended in these populations. For elderly patients, while no specific adverse reactions have been reported, caution is warranted depending on other underlying conditions or medications taken. In case of overdose, serious heart issues or central nervous system symptoms may appear, necessitating immediate medical attention. This medication should be kept out of reach of children and should not be transferred to another container.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, euphoric mood, happy mood, thought disorder, sexual dysfunction, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic contractions, seizures, akathisia, Buccoglosso syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, 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, alopecia, tendency for increased bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, micturition disorders, gynecological bleeding, erectile dysfunction, ejaculation disorder, 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, 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, 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 sealed container to protect it from air and moisture. A storage temperature between 1 to 30 degrees Celsius at room temperature is recommended.

Appearance

A hard capsule with a green upper part and a pale yellow lower part filled with a white to grayish powder

Package unit

30 capsules/bottle, 300 capsules/bottle