Medication info

Vortisetin 15 mg (Vortioxetine Hydrobromide)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Vortioxetine Hydrobromide›19.065mg / 1 tablet
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
Pale orange, oblong film-coated tablet
Packaging
200 tablets/bottle
Approval status
Active

MFDS item code 202301276 · Approved 2023.04.19

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults
Adult dosage
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 To ensure the treatment effect, medication for at least 6 months is recommended even after depressive symptoms have resolved. 2) Discontinuation This medicine may be discontinued immediately without the need for gradual dose reduction. Use in elderly patients For 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 per day. Use with cytochrome P450 inhibitors and inducers When this medicine is 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). When this medicine is 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). Use with monoamine oxidase inhibitors (MAOIs) Switching MAO inhibitors used to treat 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, at least 14 days must have elapsed after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. Other MAO inhibitors, such as linezolid or methylene blue Because of the increased risk of serotonin syndrome, treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, consider whether to administer this medicine. Linezolid or intravenous methylene blue may need to be administered urgently 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 discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Unimed 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 refers to a condition where mood is persistently depressed, and daily life may become difficult. This drug alleviates symptoms of depression and helps stabilize mood. Through consistent treatment, it aids in improving symptoms and preventing relapse. Therefore, it is effective in enhancing the quality of life for patients with major depressive disorder.

Dosage and Administration

Adult dosage

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 To ensure the treatment effect, medication for at least 6 months is recommended even after depressive symptoms have resolved. 2) Discontinuation This medicine may be discontinued immediately without the need for gradual dose reduction. Use in elderly patients For 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 per day. Use with cytochrome P450 inhibitors and inducers When this medicine is 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). When this medicine is 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). Use with monoamine oxidase inhibitors (MAOIs) Switching MAO inhibitors used to treat 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, at least 14 days must have elapsed after discontinuing this medicine before starting an MAO inhibitor to treat a psychiatric disorder. Other MAO inhibitors, such as linezolid or methylene blue Because of the increased risk of serotonin syndrome, treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue. For patients requiring other interventions, including hospitalization, or more urgent treatment of a psychiatric condition, consider whether to administer this medicine. Linezolid or intravenous methylene blue may need to be administered urgently 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 discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous doses of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses.

Precautions

This drug is an antidepressant used for the treatment of major depression, specifically acting on the serotonin neurotransmitter system to improve mood. When taking this medication, there may be an increase in suicidal impulses or behaviors, so especially young patients aged 18 to 24 require careful evaluation and ongoing monitoring by a physician. Additionally, this drug may cause a serious side effect known as serotonin syndrome, which includes various symptoms such as changes in mental status, high fever, tremors, and vomiting. The risk of this could be heightened when taken with other serotonergic drugs or certain psychiatric medications, so special caution is necessary during concurrent administration. This medication should not be used with MAO inhibitors, and at least 14 days should elapse after stopping an MAO inhibitor before starting this medication. Patients with a history of seizures or those with manic, hypomanic, or bipolar disorder must consult a doctor before using this drug. Caution is also required for those with a tendency for bleeding or currently taking anticoagulants or medications that affect platelet function. Common side effects of this drug may include nausea, diarrhea, dizziness, insomnia, anxiety, headache, drowsiness, sedation, blurred vision, flushing, increased sweating, hair loss, skin discoloration, dermatitis, nausea, diarrhea, constipation, vomiting, generalized itching, night sweats, angioedema, hives, rash, hyperhidrosis, nosebleeds, chest discomfort, physical discomfort, facial swelling, colds, tinea, bronchitis, cough, asthma, and increased phlegm. Additionally, this drug can cause pupil dilation, increasing the risk of angle-closure glaucoma, so patients with high intraocular pressure should be cautious. Abrupt discontinuation during use can trigger withdrawal symptoms such as nausea, sweating, anxiety, and dizziness, so it is recommended to gradually reduce the dosage. Pregnant or breastfeeding women should consult a doctor before using this drug, as it may affect the fetus or newborn. The safety and efficacy of this drug in children and adolescents have not been adequately proven, so it is not recommended for this age group. Elderly patients, particularly those over 65 years, require careful monitoring and dosage adjustment. Patients with severely impaired liver or kidney function should also exercise caution when taking this drug. This drug may interact with other medications, so all medications being taken should be disclosed to a doctor or pharmacist, especially when taken in combination with serotonergic drugs, anticoagulants, certain antibiotics, analgesics, etc. In case of overdose, symptoms such as nausea, dizziness, diarrhea, and drowsiness may occur, and immediate medical attention should be sought. This medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Side effects

  • suicidal urges
  • suicidal tendencies
  • serotonin syndrome
  • neuroleptic malignant syndrome
  • anaphylactic reaction
  • hyperprolactinemia
  • nosebleed
  • decreased appetite
  • abnormal dreams
  • bruxism
Show 106 more
  • insomnia
  • agitation
  • aggression
  • stickiness disorders
  • restless legs syndrome
  • dizziness
  • headache
  • blurred vision
  • mydriasis
  • flushing
  • bleeding
  • vaginal bleeding
  • sexual dysfunction
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • gastrointestinal bleeding
  • generalized itching
  • night sweats
  • angioedema
  • hives
  • rash
  • hyperhidrosis
  • abdominal pain
  • gastroesophageal reflux
  • abdominal discomfort
  • gastritis
  • esophagitis
  • atrophic gastritis
  • gum pain
  • worsening headache
  • limb tremor
  • sensory disturbances
  • tremors
  • vertigo
  • incapacity to sit cross-legged
  • worsening depression
  • intentional self-harm
  • suicide
  • sleep disorders
  • anxiety
  • hallucinations
  • mood swings
  • mood disorders
  • hypersomnia
  • mood disorders
  • increased appetite
  • loss of will
  • increased sweating
  • night sweats
  • angioedema
  • hives
  • rash
  • hyperhidrosis
  • generalized weakness
  • chest discomfort
  • physical discomfort
  • facial edema
  • cold
  • tinea
  • bronchitis
  • cough
  • asthma
  • increased phlegm
  • joint pain
  • muscle pain
  • weight gain
  • thirst
  • weight loss
  • diabetes
  • dysuria
  • frequency of urination
  • acute cholecystitis
  • hepatitis
  • tinnitus
  • varicose veins
  • benign prostatic hyperplasia
  • incontinence
  • fainting
  • iron deficiency anemia
  • orthostatic hypotension
  • unspecified cyst
  • dyspepsia
  • heartburn
  • dry mouth
  • upper abdominal pain
  • unspecified gastrointestinal disease
  • drowsiness
  • sedation
  • fatigue
  • palpitations
  • nausea
  • position-related dizziness
  • abdominal discomfort
  • generalized itching
  • drowsiness
  • flushing
  • irritability
  • sensory impairment
  • confusion
  • hypersomnia
  • emotional instability
  • hypomania
  • tinnitus
  • seizures

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, preferably at room temperature between 1 degree and 30 degrees. Storing in this manner helps maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Pale orange, oblong film-coated tablet

Package unit

200 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.