Brintellix Tablets 10 mg (Vortioxetine Hydrobromide)

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 behavior in children, adolescents, and young adults with major depression or other psychiatric disorders, so careful judgment is necessary when used, especially in patients aged 18 to 24 years. This drug can cause a serious side effect known as serotonin syndrome, which includes changes in mental status, autonomic instability, muscle spasms, seizures, gastrointestinal symptoms, etc. The risk of these issues increases when combined with other serotonergic drugs or certain antidepressants and MAO inhibitors, so it must be taken under the direction of a physician. This drug should not be administered to patients who are hypersensitive to any component or are 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 be treated with extra caution. The most common side effect is nausea, which usually appears within the first 2 weeks of treatment and is typically temporary. Other possible effects include dizziness, diarrhea, constipation, insomnia, headache, generalized itching, rash, and bleeding. Discontinuation of this medication can lead to withdrawal symptoms such as dizziness, headache, anxiety, tremors, and insomnia, so it is advised to taper the dosage gradually. Pregnant or breastfeeding women should exercise caution in using this medication; particularly in late pregnancy, it can cause symptoms such as respiratory distress, seizures, and feeding difficulties in newborns, and therefore consultation with a physician is required. This medication is metabolized by various enzymes in the liver, so there may be interactions with other medications. Particularly, the risk of side effects may increase when concomitantly used with CYP2D6 inhibitors or serotonergic drugs, so it is important to inform the doctor of all medications being taken. Care should be taken when driving or operating dangerous machinery, and it should be kept out of reach of children. Overdose may result in symptoms such as nausea, dizziness, diarrhea, and drowsiness, and immediate medical attention should be sought for appropriate treatment.

Suicidal thoughts, suicidal tendencies, serotonin syndrome, neuroleptic malignant syndrome, anaphylactic reactions, hyperprolactinemia, nosebleeds, decreased appetite, abnormal dreams, teeth grinding, insomnia, agitation, aggression, akathisia, restless legs syndrome, dizziness, headaches, blurred vision, mydriasis, flushing, bleeding, vaginal bleeding, sexual dysfunction, nausea, diarrhea, constipation, vomiting, gastrointestinal bleeding, generalized pruritus, night sweats, angioedema, urticaria, rash, hyperhidrosis, withdrawal syndrome, withdrawal symptoms (dizziness, headaches, sensory disturbances, sleep disturbances, anxiety, irritability, agitation, fatigue, tremors), sexual dysfunction, increased risk of fractures, abdominal pain, gastroesophageal reflux, abdominal discomfort, gastritis, esophagitis, atrophic gastritis, gum pain, worsened headaches, limb tremors, paraesthesia, tremors, inability to sit still, worsened depression, self-harm, suicide, sleep disorders, anxiety, hallucinations, mood swings, affective disorders, hypersomnia, mood disorders, increased appetite, loss of will, increased sweating, hair loss, skin discoloration, dermatitis, generalized weakness, chest discomfort, physical discomfort, facial swelling, cold, tinea, bronchitis, cough, asthma, increased sputum, arthralgia, myalgia, weight gain, thirst, weight loss, diabetes, dysuria, frequent urination, acute cholecystitis, hepatitis, tinnitus, varicose veins, benign prostatic hyperplasia, hyperhidrosis, syncope, iron deficiency anemia, orthostatic hypotension, unexplained cysts, dyspepsia, heartburn, dry mouth, upper abdominal pain, unexplained gastrointestinal disorders, drowsiness, sedation, fatigue, palpitations, withdrawal symptoms (nausea, sweating, unpleasant mood, irritability, agitation, dizziness, sensory disturbances, tremors, anxiety, confusion, headaches, somnolence, emotional instability, insomnia, hypomania, tinnitus, seizures)

This medication should be stored in a tightly sealed container to avoid contact with air or moisture, and the storage temperature should be kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance

Yellow film-coated oval tablets imprinted with "TL" on one side and "10" on the other side.

Package unit

28 tablets (14 tablets/PTP × 2), 7 tablets (7 tablets/PTP × 1)