Brintellix Tablet 15 mg (Vortioxetine Bromohydrochloride)

Adult dosage

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 reduced to a minimum of 5mg. This drug may be taken with or without food. 1) Maintenance treatment To ensure the therapeutic effect, drug treatment for at least 6 months is recommended even after the depressive symptoms have resolved. 2) Discontinuation This drug may be discontinued immediately without the need for gradual dose reduction. 2. Use in elderly patients In elderly patients aged 65 years or older, the initial dose is 5mg once daily. Use caution when treating with this drug at doses of 10mg or more daily. 3. Use with cytochrome P450 inhibitors and inducers 1) Cytochrome P450 inhibitors When this drug is coadministered with potent cytochrome P450 inhibitors (e.g., bupropion, quinidine, fluoxetine, and paroxetine), reduce the dose of this drug according to the patient's response (see section 6. Interactions). 2) Cytochrome P450 inducers When this drug is coadministered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, and 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 MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 14 days must have elapsed after discontinuing this drug 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 must not start this drug because of the increased risk of serotonin syndrome. For patients who require other interventional procedures, including hospitalization, or more urgent treatment of a psychiatric condition, the use of this drug should be considered. 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be restarted 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 with intravenous administration of this drug at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication is used for the treatment of psychiatric disorders such as Major Depression, and caution is required, especially in children, adolescents, and young adults, as there is an increased risk of suicidal thoughts and behaviors. During treatment with this medication, attention should be paid to observe any abnormal behavioral changes such as suicidal tendencies, aggression, and anger, and family members or caregivers should monitor the patient closely. A severe side effect known as serotonin syndrome may occur, so caution is particularly necessary when used in combination with other serotonergic medications. If symptoms appear, the medication should be discontinued immediately, and medical advice should be sought. This medication should not be taken with certain drugs, particularly monoamine oxidase inhibitors (MAOIs), as this poses risks, and at least 14 days must pass after discontinuing an MAOI before starting this medication. Patients with a history of seizures or unstable epilepsy, manic or bipolar disorder, severe kidney or liver disorders, bleeding tendencies, those on anticoagulants, and the elderly should use this medication with caution. Common side effects such as nausea, dizziness, insomnia, anxiety, headache, and diarrhea may occur within the first 2 weeks of use but are typically transient and do not require discontinuation of treatment. Care should be taken when driving or operating hazardous machinery, as abrupt discontinuation may induce withdrawal symptoms, so dosage should be reduced gradually. During pregnancy, the medication should only be used if there is a clinical necessity due to potential risks to the fetus, and during breastfeeding, careful consideration is needed as the drug may be transmitted through breast milk. Safety and efficacy in children and adolescents have not been sufficiently established and is therefore not recommended, and caution and monitoring are required for elderly patients receiving more than 10 mg. In cases of overdose, symptoms such as nausea, dizziness, diarrhea, and drowsiness may appear, warranting immediate medical attention and monitoring. This medication should be kept out of reach of children, and care should be taken not to transfer it to another container as this may lead to accidents and degradation of quality.

suicidal ideation, suicide tendency, serotonin syndrome, neuroleptic malignant syndrome, agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremor, euphoria, myotonia, parkinsonism, coordiantion disorders, seizures, nausea, vomiting, diarrhea, anaphylactic reaction, hyperprolactinemia, nosebleeds, decreased appetite, abnormal dreams, bruxism, insomnia, aggressiveness, dysphoria, restless legs syndrome, lightheadedness, headache, mydriasis, flushing, bleeding, vaginal bleeding, sexual dysfunction, nausea, diarrhea, constipation, vomiting, gastrointestinal bleeding, generalized pruritus, night sweats, angioedema, urticaria, rash, hyperhidrosis, abdominal pain, gastroesophageal reflux, abdominal discomfort, gastritis, esophagitis, atrophic gastritis, gum pain, exacerbation of headaches, limb tremors, sensory abnormalities, tremors, dizziness, inability to maintain a sitting position, worsening of depression, self-harm, suicide, sleep disorders, anxiety, hallucinations, emotional lability, mood disorder, hypersomnia, mood disturbances, increased appetite, loss of willpower, increased sweating, hair loss, skin discoloration, dermatitis, generalized weakness, chest discomfort, physical discomfort, facial swelling, cold, tinea, bronchiolitis, cough, asthma, increased sputum, arthralgia, myalgia, weight gain, thirst, weight loss, diabetes, dysuria, polyuria, acute cholecystitis, hepatitis, tinnitus, varicose veins, benign prostatic hyperplasia, enuresis, syncope, iron deficiency anemia, orthostatic hypotension, cyst of unspecified origin, dyspepsia, heartburn, dry mouth, epigastric pain, gastrointestinal disease of unspecified origin, drowsiness, sedation, fatigue, palpitations, nausea, position-related dizziness, abdominal discomfort, generalized pruritus, drowsiness, flushing

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Orange egg-shaped film-coated tablet engraved with 'TL' on one side and '15' on the other side.

Package unit

28 tablets (14 tablets/PTP × 2)