Botive 10 mg Tablet (Botioxetine Hydrochloride)

Adult dosage

1. Adults The initial and recommended dose of this drug is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily or decreased to a minimum of 5mg daily. This drug may be taken with or without food. 1) Maintenance treatment To ensure the therapeutic effect, medication is recommended for at least 6 months even after depressive symptoms have resolved. 2) Discontinuation This drug may be discontinued immediately without the need for gradual dose reduction. 2. Use in older adults For patients aged 65 years and older, the initial dose is 5mg once daily. Use caution when treating with this drug at doses of 10mg or more per day. 3. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When coadministered with strong cytochrome P450 inhibitors (e.g., bupropion, quinidine, fluoxetine, paroxetine), reduce the dose of this drug according to the patient's response (see section 6. Interactions). 2) Cytochrome P450 inducers When coadministered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, phenytoin), the dose of this drug may be adjusted according to the patient's response (see section 6. Interactions). 4. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days after discontinuing an MAO inhibitor used to treat a psychiatric disorder before starting treatment with this drug. Conversely, at least 14 days must elapse after discontinuing this drug before starting an MAO inhibitor for the treatment of a psychiatric disorder. 2) Other MAO inhibitors, such as linezolid or methylene blue Treatment with this drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, consider whether to administer this drug. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug at a dose 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 an antidepressant used for the treatment of major depression. The risk of suicidal thoughts or behavior may increase, especially in pediatric, adolescent, and young adult patients, so a physician must carefully evaluate the need and risks of using this medication. This medication can potentially cause a life-threatening side effect known as serotonin syndrome. The risk may be increased when taken with other serotonergic medications, necessitating caution. This medication should not be taken with certain drugs, particularly MAO inhibitors, which require a minimum interval of 14 days. Patients with a history of seizures, epilepsy, mania, severely impaired liver or kidney function, bleeding tendencies, or those taking medications affecting blood clotting, as well as older adults, should be treated with caution. During the use of this medication, various side effects like nausea, dizziness, insomnia, bleeding, and sexual dysfunction may occur. Should these symptoms appear, consult a healthcare professional. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus or baby before taking this medication. This medication is not recommended for children; dosage adjustment and careful monitoring are necessary for elderly patients. In case of overdose, symptoms such as nausea, dizziness, and seizures may appear, so it is vital to adhere strictly to the prescribed dose. Store this medication out of the reach of children and do not transfer it to another container. Caution is required while driving or operating hazardous machinery during treatment, and a gradual dose reduction is recommended to prevent withdrawal syndrome. Finally, there may be interactions with other medications while taking this medication, so notify your healthcare provider about all medications you are taking.

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

This medication should be stored in a tightly sealed container to protect it from air and humidity. It is recommended to maintain a storage temperature between 1°C and 30°C room temperature. This helps to retain the efficacy of the medication for a longer period.

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle