Botisetin Tablet 10mg (Botioxetine Hydrochloride)

Adult dosage

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 the treatment effect, medication for at least 6 months is recommended even after depressive symptoms have resolved. 2) Discontinuation This medicine may be discontinued immediately without the need for gradual dose reduction. Use in elderly patients For patients aged 65 years or older, the initial dose is 5mg once daily. Use caution when treating with this medicine at doses of 10mg or more per day. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When this medicine is co-administered with potent cytochrome P450 inhibitors (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 this medicine is co-administered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, phenytoin), the dose of this medicine may be adjusted according to the patient's response (see Section 6. Interactions). Use with monoamine oxidase inhibitors (MAOIs) 1) Switching MAO inhibitors 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 allowed. Conversely, at least 14 days must have elapsed after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. 2) Other MAO inhibitors, such as linezolid or methylene blue Because of the increased risk of serotonin syndrome, treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, consider whether to administer this medicine. Linezolid or intravenous methylene blue may need to be administered urgently to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue 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 medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

This drug may increase the risk of suicidal thoughts or behavior in young people with major depression or psychiatric disorders; therefore, a doctor must carefully decide whether to prescribe it. Patients or caregivers should closely monitor for abnormal behavioral changes such as suicidal thoughts, aggression, and anger while taking this medication and should consult a doctor immediately if unusual symptoms arise. This drug can cause a serious side effect known as serotonin syndrome, so it should not be taken with serotonergic drugs, certain antidepressants, or MAO inhibitors. Symptoms of serotonin syndrome include agitation, hallucinations, tremors, high fever, nausea, and diarrhea. If these symptoms occur, the medication should be stopped immediately, and medical attention should be sought. This drug should not be used in patients with allergies to its components or those taking MAO inhibitors. Patients with a history of seizures, mania, hypomania, bipolar disorder, severe renal or liver impairment, bleeding tendencies, or those taking anticoagulants, as well as elderly patients, should use this drug with caution. The most common side effect when taking this medication is nausea, which is usually mild and temporary, but gastrointestinal disturbances, headaches, insomnia, dizziness, and bleeding may also occur. This drug does not significantly affect the ability to drive or operate machinery; however, caution may be necessary depending on the individual. Suddenly stopping this medication may result in withdrawal symptoms such as nausea, sweating, anxiety, headaches, and dizziness; therefore, the dosage should be gradually reduced according to the doctor's instructions. If you are pregnant or breastfeeding, using this medication may affect the fetus or newborn, so it is essential to consult a doctor. The safety and effectiveness of this medication have not been sufficiently established in children or adolescents, so it is not recommended for them. Since this drug is metabolized in the liver, patients with impaired liver function should be cautious, and it is crucial to inform the doctor or pharmacist of any other medications being taken due to the possibility of drug interactions. Overdose may lead to symptoms such as nausea, dizziness, diarrhea, and drowsiness, and immediate medical treatment is required. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

• suicidal thoughts
• suicidal tendencies
• serotonin syndrome
• neuroleptic malignant syndrome
• anaphylaxis
• hyperprolactinemia
• nosebleed
• decreased appetite
• abnormal dreams
• teeth grinding

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow rectangular film-coated tablet

Package unit

200 tablets/bottle