Votib 5 mg Tablets (Vortioxetine Hydrobromide)

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 in the treatment of Major Depression and may increase the risk of suicidal thoughts or behaviors, especially in children, adolescents, and young adults. During treatment, family members or caregivers should closely monitor for worsening depression or any abnormal behavioral changes such as suicidal thoughts, aggression, or anger. There is a risk of a serious side effect known as serotonin syndrome, which can occur when taken with other serotonergic drugs. Serotonin syndrome can cause various symptoms, including anxiety, confusion, tremors, fever, and vomiting; if these symptoms appear, the patient should stop taking the medication immediately and seek medical attention. This medication should not be taken with MAO inhibitors, and at least 14 days must pass after taking an MAO inhibitor before starting this medication. Patients with a history of seizures or those with mania, hypomania, or bipolar disorder should be treated with caution, as should patients with severe kidney or liver dysfunction. Patients with a tendency to bleed or those taking anticoagulants or medications affecting platelet function may be at increased risk of bleeding. Common side effects during treatment may include nausea, diarrhea, headache, dizziness, insomnia, and anxiety; in rare cases, serious allergic reactions or bleeding may occur. Pregnant or breastfeeding women should consult their doctor before taking this medication as it may affect the fetus or infant. Elderly patients may require dosage adjustments and should be monitored closely; it is advisable to taper off the medication gradually instead of stopping abruptly. This medication can interact with various drugs, so if the patient is taking other medications, they must inform their doctor or pharmacist. Safety and efficacy for children have not been established, so it is not recommended for use in that age group. Finally, this medication should be stored out of reach of children, and it should be taken exactly as prescribed.

• suicidal ideation
• suicidal tendencies
• serotonin syndrome
• neuroleptic malignant syndrome
• anaphylactic reaction
• hyperprolactinemia
• epistaxis
• decreased appetite
• abnormal dreams
• bruxism

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

Appearance

Yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle