Brintellix Tablet 20 mg (Vortioxetine Bromide)

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 Drug treatment for at least 6 months is recommended to ensure a satisfactory treatment effect, even after depressive symptoms have resolved. 2) Discontinuation Gradual dose reduction may be considered to minimize the occurrence of withdrawal symptoms (see “4. Adverse reactions” under Precautions for Use). However, there are insufficient data to provide a specific dose-reduction schedule applicable to patients treated with this medicine. 2. Use in elderly patients In 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 daily. 3. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When 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 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). 4. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching MAO inhibitors for the treatment of 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, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. 2) Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start this medicine because of the increased risk of serotonin syndrome. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, whether to administer this medicine should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue 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 stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous doses of 1mg/kg or less of this medicine is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depression or psychiatric disorders; therefore, careful assessment by a physician and vigilant observation by patients and guardians are essential. This medication can cause a serious side effect known as serotonin syndrome, and the risk is heightened when taken with other serotonergic medications, certain antipsychotics, or MAO inhibitors. If symptoms such as changes in mental state, high fever, tremors, or nausea occur while taking this medication, discontinue use immediately and consult a physician. This medication should not be used in patients allergic to the active ingredient or any components, or in patients currently taking or who have recently stopped taking an MAO inhibitor. Special caution is needed in patients with a history of seizures, mania, hypomania, severe liver or kidney dysfunction, a tendency to bleed, or those taking anticoagulants. The most common side effect is nausea, which typically occurs within 2 weeks of starting treatment and is transient. Other reported side effects include dizziness, insomnia, headache, diarrhea, skin rash, etc. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, headache, and anxiety, so it is advisable to gradually reduce the dosage. This medication is metabolized by several enzymes in the liver, so it may interact with other drugs, particularly when used in combination with MAO inhibitors, serotonergic medications, or strong CYP2D6 inhibitors. During pregnancy, it should be used carefully under a physician's judgment due to potential effects on the fetus, and during breastfeeding, caution should be exercised as this medication may be passed into breast milk. Safety and efficacy in children have not been sufficiently established; therefore, it is not recommended. Elderly patients require careful dosage adjustment and monitoring. In case of an overdose, symptoms such as nausea, dizziness, diarrhea, and drowsiness may occur, requiring immediate medical attention and monitoring. This medication should be kept out of reach of children, and transferring it to another container may pose risks of accidents or quality deterioration.

Suicidal thoughts, suicidal tendencies, agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, excitement, myoclonus, akathisia, coordination disorder, seizures, nausea, vomiting, diarrhea, anaphylactic reaction, hyperprolactinemia, nosebleeds, decreased appetite, abnormal dreams, teeth grinding, insomnia, aggression, akinesia, restless legs syndrome, vertigo, serotonin syndrome, headache, blurred vision, mydriasis, flushing, bleeding, vaginal bleeding, sexual dysfunction, nausea, diarrhea, constipation, vomiting, gastrointestinal bleeding, systemic itching, night sweats, angioedema, urticaria, rash, hyperhidrosis, withdrawal syndrome, dizziness, headache, sensory disturbance, sleep disturbance, anxiety, irritability, fatigue, tremors, sexual dysfunction, fractures, abdominal pain, gastroesophageal reflux, abdominal discomfort, atrophic gastritis, gum pain, exacerbation of headache, limb tremors, sensory abnormalities, tremors, dizziness, inability to sit still, exacerbation of depression, self-harm, suicide, sleep disorders, anxiety, hallucinations, mood swings, mood disorders, hypersomnia, mood disorder, increased appetite, loss of willpower, increased sweating, hair loss, skin discoloration, dermatitis, generalized weakness, chest discomfort, physical discomfort, facial swelling, cold, ringworm, bronchitis, cough, asthma, increased phlegm, joint pain, muscle pain, weight gain, thirst, weight loss, diabetes, difficulty urinating, frequent urination, acute cholecystitis, hepatitis, tinnitus, varicose veins, benign prostatic hyperplasia, overflow incontinence, fainting, iron deficiency anemia, orthostatic hypotension, cyst of unspecified nature, dyspepsia, heartburn, dry mouth, upper abdominal pain, gastrointestinal disease of unspecified nature, drowsiness, sedation, fatigue, palpitations, nausea, vomiting, headache, dizziness, abdominal pain

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Red oval film-coated tablet with 'TL' engraved on one side and '20' on the other side.

Package unit

28 tablets (14 tablets/PTP × 2)