Medication info

Votib Tablets 20 Milligrams (Vortioxetine Hydrobromide)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Vortioxetine Hydrobromide›25.42mg / 1 tablet
Manufacturer / importer
Hanon Pharmaceutical Co., Ltd.
Appearance
Yellow, rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202301537 · Approved 2023.05.12

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults
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.

Ingredients

Manufacturer
Hanon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depressive disorder
View approved original text

This medication is used to treat major depressive disorder. Major depressive disorder is a mental health issue characterized by persistently low mood that interferes with daily life; this drug helps alleviate these symptoms, supporting emotional stability for the patient. Through treatment, it contributes to the improvement of depressive mood, lethargy, reduced concentration, and enhances quality of life. It is important to take this medication regularly as prescribed by a physician and to consult immediately if side effects occur.

Dosage and Administration

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.

Precautions

This medication is an antidepressant used in the treatment of major depression, particularly acting on the serotonin system to improve mood. During treatment, there is an increased risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so consultation with a physician is essential before administering, and careful judgment is needed. There may be a serious side effect called serotonin syndrome, which manifests as symptoms such as anxiety, confusion, fever, tremors, and vomiting; if any abnormal signs are observed, the medication should be stopped immediately, and medical attention should be sought. Taking this medication in conjunction with certain drugs, especially MAO inhibitors or serotonergic drugs, increases risk and should be avoided. Patients with a history of seizures or epilepsy, those with mania or bipolar disorder, and those with severe kidney or liver impairment should exercise greater caution in using this medication. If there is a tendency for bleeding or if the patient is taking anticoagulants or medications affecting platelet function, the risk of bleeding may increase; consulting a physician before use is advised. This medication may commonly cause side effects such as nausea, dizziness, and insomnia at the start of treatment; however, these are usually transient and mild. Women who are pregnant or breastfeeding should discuss this with healthcare professionals before use, as it may affect the fetus or newborn. Sudden discontinuation of this medication may trigger withdrawal symptoms such as dizziness, anxiety, and headaches; therefore, dosage should be gradually reduced as per the doctor's instructions. Use of this medication is limited in children and the elderly, with particular attention needed for elderly patients regarding dosage adjustments and monitoring. It is advisable not to take this medication with alcohol, and caution should be exercised when driving or operating machinery. In cases of overdose, symptoms may include nausea, dizziness, and seizures, and immediate medical attention is required. Lastly, this medication should be stored out of reach of children, and it is safer not to transfer it to other containers.

Side effects

suicidal thoughts, suicidal tendencies, serotonin syndrome, neuroleptic malignant syndrome, changes in mental state (anxiety, hallucinations, delirium, coma), autonomic nervous system anxiety (tachycardia, unstable blood pressure, dizziness, sweating, flushing, fever), neuromuscular symptoms (tremors, rigidity, fasciculation, akathisia, coordination disorders), seizures, nausea, vomiting, diarrhea, decreased appetite, abnormal dreams, bruxism, insomnia, anxiety, aggression, vocal cord dysfunction, restless legs syndrome, dizziness, headache, blurred vision, mydriasis, flushing, bleeding (bruising, petechiae), vaginal bleeding, sexual dysfunction, systemic itching, night sweats, angioedema, urticaria, rash, hyperhidrosis, abdominal pain, gastroesophageal reflux, abdominal discomfort, gastritis, esophagitis, atrophic gastritis, gum pain, worsening headache, limb tremors, sensory disturbances, tremors, inability to sit still, worsening depression, deliberate self-harm, suicide, sleep disorders, anxiety, hallucinations, mood swings, emotional disorders, hypersomnia, mood disorders, increased appetite, loss of volition, increased sweating, hair loss, skin discoloration, dermatitis, systemic weakness, chest discomfort, physical discomfort, facial swelling, cold, tinea, bronchitis, cough, asthma, increased sputum, arthralgia, myalgia, diabetes, weight gain, thirst, weight loss, urinary difficulty, frequent urination, acute cholecystitis, hepatitis, tinnitus, varicose veins, benign prostatic hyperplasia, incontinence, syncope, iron deficiency anemia, orthostatic hypotension, cyst of unknown origin, dyspepsia, heartburn, dry mouth, upper abdominal pain, gastrointestinal disease of unknown origin, drowsiness, sedation, fatigue, palpitations, nausea, position-related dizziness, abdominal discomfort

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain its effectiveness and prevents degradation.

Appearance and packaging

Appearance

Yellow, rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.