Nobsetin Capsule (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 in 2 divided doses (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 or longer after the start of treatment. 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 symptoms 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 the amount needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day. 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 illnesses: Administer a low dose or reduce the frequency of administration. Adjust the dose 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 drug, an interval of at least 14 days must be observed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, 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 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, consider treatment. 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 comes first. Treatment with this drug 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 with intravenous administration of this drug 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 an antidepressant primarily used to treat psychiatric conditions such as depression. During treatment, especially in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors; therefore, patients and families should closely monitor any changes in symptoms. This drug should not be administered to certain patients, such as those allergic to the drug or its additives, those with severe renal impairment, and patients taking certain medications (e.g., MAO inhibitors). Patients with a history of seizures or high suicidal risk, those with heart disease, or patients with impaired liver or kidney function, and diabetics should use this medication with special caution and under medical supervision. Common side effects may include headache, nausea, insomnia, fatigue, diarrhea, while rare serious side effects, such as allergic reactions or cardiac arrhythmias, may occur. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so dosage should be gradually reduced under a physician’s guidance when stopping treatment. Additionally, this medication may interact with other drugs, so inform your doctor or pharmacist if you are taking any other medications, and it’s advisable to avoid alcohol consumption. Pregnant or breastfeeding women should consult healthcare providers before taking this medication, as it may affect the fetus or newborn. The safety and efficacy in pediatric and adolescent populations have not been adequately established, hence its use is not recommended. In elderly patients, while no specific adverse reactions have been reported, caution is advised according to other conditions or medications being taken. In case of overdose, serious symptoms, such as nausea, seizures, or heart problems, may occur, so strict adherence to prescribed dosages is necessary, and immediate medical attention is required in case of adverse symptoms. Lastly, this medication should be stored in a safe place 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, irritability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, abnormal thoughts, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste abnormalities, hypersomnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, seizures, akathisia, serotonin syndrome, memory disorders, blurred vision, dilated pupils, palpitations, ventricular arrhythmias, 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, hair loss, tendency to bruise easily, cold sweats, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myopathy, myalgia, frequent urination, dysuria, urinary retention, micturition 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 values, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, renal, hepatic or pulmonary related reactions, growth delay, delayed puberty, Stevens-Johnson syndrome, toxic epidermal necrolysis, platelet function alteration, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening 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 protect it from air and moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and ensure its safe use.

Appearance

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

Package unit

30 capsules/bottle, 300 capsules/bottle