Boseitin Tablet 10 mg (Botifoxetine Hydrobromide)

Adult dosage

1. Adults The initial and recommended dose of this medicine is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily or reduced to a minimum of 5mg daily. This medicine may be taken with or without food. 1) Maintenance treatment To ensure a therapeutic effect, medication treatment for at least 6 months is recommended, even after depressive symptoms have resolved. 2) Discontinuation This medicine may be discontinued immediately without gradually reducing the dose. 2. Use in elderly patients For elderly patients aged 65 years and older, the initial dose is 5mg once daily. Treat with caution if administering this medicine at doses of 10mg or more daily. 3. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When coadministered with a potent cytochrome P450 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine), reduce the dose of this medicine according to the patient's response (see section 6. Interactions). 2) Cytochrome P450 inducers When coadministered with a broad-spectrum cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin), the dose of this medicine may be adjusted according to the patient's response (see section 6. Interactions). 4. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching from an MAO inhibitor used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, an interval of at least 14 days must be observed. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. 2) 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 other interventions, including hospitalization, or treatment for a more urgent psychiatric condition, the use of this medicine should be considered. If urgent administration of linezolid or intravenous methylene blue is necessary in a patient already receiving this medicine, and 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after starting linezolid or intravenous methylene blue, or for 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 doses of 1mg/kg or less of this medicine are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Careful observation is required for children, adolescents, and young adults with depression or psychiatric disorders as this medication may increase the risk of suicidal thoughts or behaviors. There is a risk of serious side effects called serotonin syndrome, and caution is advised when combined with other serotonergic medications. This drug should not be used in patients allergic to its ingredients or those taking MAO inhibitors. Patients with a history of seizures, severely impaired liver or kidney function, those at risk of bleeding, and the elderly should be treated with caution. During the initial stages of treatment, side effects such as nausea, dizziness, and insomnia may occur, necessitating attention. Sudden discontinuation of this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced. If pregnant or breastfeeding, it should be used with caution after consulting a doctor, and it is not recommended for children. Due to numerous drug interactions, patients must inform their doctor or pharmacist if they are taking any other medications. Caution is needed when driving or operating machinery, and alcohol consumption should be avoided. Overdose may result in symptoms such as nausea, dizziness, and seizures, requiring immediate medical attention. Keep out of reach of children and do not transfer to other containers for safety.

• suicidal impulses
• suicidal tendencies
• serotonin syndrome
• neuroleptic malignant syndrome
• agitation
• hallucinations
• delirium
• coma
• tachycardia
• unstable blood pressure

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Maintaining the storage temperature between 1 and 30 degrees Celsius at room temperature is important to safely preserve the medication's effectiveness.

Appearance

Yellow rectangular film-coated tablet

Package unit

200 tablets/bottle