Proinine Capsule (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg orally once daily in the morning. In controlled clinical trials, doses of 20～80mg per day were administered. If no improvement is observed, a dose increase 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 medication, but psychopharmacologists agree that acute symptoms 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 the amount needed to maintain or sustain remission. 2. Bulimia nervosa Administer this medication 60mg per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer this medication 20～60mg per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer this medication 20mg 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 comorbidities: 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 medication, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks must elapse after discontinuing this medication. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue preparations should not start treatment with this medication because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. It may be necessary to urgently administer linezolid or an intravenous methylene blue preparation to a patient already receiving this medication. 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, discontinue this medication immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever comes first. Treatment with this medication may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medication at doses 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 such as depression. During treatment, particularly in younger patients between the ages of 18 and 24, there may be an increase in suicidal thoughts or behaviors; hence, physicians should carefully consider the necessity and risks of treatment. This medication should not be administered to certain patients, such as those with allergies to this medication or its additives, patients with severe renal impairment, and those currently taking MAO inhibitors. Particular care is required for patients with a history of seizures or who are at high risk of suicide, those with a history of mania, patients with heart disease, and those with impaired liver or kidney function. Diabetic patients should closely monitor their blood glucose levels as there may be changes in glucose control, and patients with elevated intraocular pressure or at risk for glaucoma should also exercise caution. Common side effects during treatment may include headaches, nausea, insomnia, fatigue, and diarrhea, while serious adverse effects such as severe allergic reactions or cardiac arrhythmias have been reported, albeit rarely. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, paresthesia, anxiety, and nausea; thus, it should be tapered off gradually according to a physician's instructions. Moreover, interactions may occur when used in conjunction with other medications, so patients should always discuss with their physician or pharmacist if they are taking any other medications. Pregnant or breastfeeding women should consult their doctor before using this medication due to potential effects on the fetus or infant. The safety and efficacy of this medication have not been sufficiently established in children and adolescents, and therefore it is generally not recommended for this age group. Elderly patients may also require special attention depending on underlying conditions or concurrent medications. Lastly, this medication should be kept out of reach of children, and transferring it to other containers should be avoided.

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, abnormalities of 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, cramps, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, respiratory-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequency of urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, feelings of anxiety, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, 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 closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a green upper part and a yellowish lower part filled with a white powder.

Package unit

30 capsules/bottle, 500 capsules/bottle