Medication info
Boseitin Tablet 20mg (Botioxetine Hydrochloride)

Boseitin Tablet 20mg (Botioxetine Hydrochloride)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Vortioxetine Hydrobromide›25.42mg / 1 tablet
Manufacturer / importer
Myungjin Pharmaceutical Co., Ltd.
Appearance
reddish-brown oblong film-coated tablet
Packaging
200 tablets/bottle
Approval status
Active

MFDS item code 202301256 · Approved 2023.04.17

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 once daily or reduced to a minimum of 5mg once daily. This drug may be taken with or without food. 1) Maintenance treatment To ensure a therapeutic effect, drug treatment 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. Administration to elderly patients For elderly patients aged 65 years or older, the initial dose is 5mg once daily. If this drug is administered at doses of 10mg or more once daily, treatment should be given with caution. 3. Administration 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, paroxetine, etc.), reduce the dose of this drug depending on the patient's response (see Section 6. Drug Interactions). 2) Cytochrome P450 inducers When this drug is coadministered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, phenytoin, etc.), the dose of this drug may be adjusted depending on the patient's response (see Section 6. Drug Interactions). 4. Administration with monoamine oxidase inhibitors (MAOIs) 1) Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and initiating treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this drug before initiating an MAO inhibitor to treat a psychiatric disorder. 2) Other MAO inhibitors, such as linezolid or methylene blue Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving 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 risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at a dose of 1mg/kg or less, is unclear.

Ingredients

Manufacturer
Myungjin 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 psychological condition that can significantly impact daily life, and this medication helps alleviate symptoms and maintain a stable mood. Consistent use contributes to mood improvement and the recovery of mental health.

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 once daily or reduced to a minimum of 5mg once daily. This drug may be taken with or without food. 1) Maintenance treatment To ensure a therapeutic effect, drug treatment 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. Administration to elderly patients For elderly patients aged 65 years or older, the initial dose is 5mg once daily. If this drug is administered at doses of 10mg or more once daily, treatment should be given with caution. 3. Administration 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, paroxetine, etc.), reduce the dose of this drug depending on the patient's response (see Section 6. Drug Interactions). 2) Cytochrome P450 inducers When this drug is coadministered with broad-spectrum cytochrome P450 inducers (e.g., rifampicin, carbamazepine, phenytoin, etc.), the dose of this drug may be adjusted depending on the patient's response (see Section 6. Drug Interactions). 4. Administration with monoamine oxidase inhibitors (MAOIs) 1) Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and initiating treatment with this drug, an interval of at least 14 days must be allowed. Conversely, at least 14 days must elapse after discontinuing this drug before initiating an MAO inhibitor to treat a psychiatric disorder. 2) Other MAO inhibitors, such as linezolid or methylene blue Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after receiving 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 risk associated with methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug at a dose of 1mg/kg or less, is unclear.

Precautions

This medication is primarily used to improve symptoms associated with depression. During the use of this medication, there may be an increased risk of suicidal thoughts or behaviors, especially in children, adolescents, and young adults, so careful monitoring by a physician is necessary for patients in this age group. Serotonin syndrome, a serious side effect, may occur, so special caution is required when taking it with other serotonergic medications. This medication should not be taken with certain drugs, particularly MAO inhibitors, as drug interactions may increase the risk of side effects. Caution should be exercised when administering to patients with a history of seizures, significantly impaired liver or kidney function, bleeding tendencies, and the elderly. During initial use, side effects such as nausea, dizziness, insomnia, and decreased appetite may occur, but these are mostly transient symptoms. If this medication is discontinued suddenly, withdrawal symptoms such as dizziness, sweating, and malaise may occur, so it is important to gradually reduce the dosage according to the physician's instructions when stopping. If you are pregnant or breastfeeding, this medication may affect the fetus or newborn, so it must be taken only after consultation with a physician. The safety and efficacy of this medication in children and adolescents have not been sufficiently established and are not recommended. Extra caution may be needed when driving or operating hazardous machinery due to the effects of this medication. In case of overdose, symptoms such as nausea, dizziness, and diarrhea may occur, and immediate medical attention should be sought.

Side effects

  • Suicidal impulses
  • suicidal tendencies
  • anxiety
  • hallucinations
  • delirium
  • coma
  • tachycardia
  • unstable blood pressure
  • dizziness
  • sweating
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  • flushing
  • high fever
  • tremors
  • jubilation
  • myoclonus
  • akathisia
  • dyskinesia
  • seizures
  • nausea
  • vomiting
  • diarrhea
  • anaphylactic reaction
  • hyperprolactinemia
  • nosebleeds
  • appetite loss
  • abnormal dreams
  • bruxism
  • insomnia
  • aggressiveness
  • tics
  • restless legs syndrome
  • dizziness
  • 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
  • abdominal pain
  • gastroesophageal reflux
  • abdominal discomfort
  • gastritis
  • esophagitis
  • atrophic gastritis
  • gum pain
  • headache exacerbation
  • limb tremors
  • sensory disturbance
  • tremors
  • dizziness
  • inability to sit still
  • depression exacerbation
  • intentional self-harm
  • suicide
  • sleep disorders
  • anxiety
  • hallucinations
  • emotional lability
  • mood disorder
  • hypersomnia
  • mood disorder
  • increased appetite
  • anhedonia
  • increased sweating
  • hair loss
  • skin discoloration
  • dermatitis
  • systemic weakness
  • chest discomfort
  • bodily 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
  • overflow incontinence
  • syncope
  • iron deficiency anemia
  • orthostatic hypotension
  • unspecified cyst
  • dyspepsia
  • heartburn
  • dry mouth
  • upper abdominal pain
  • unspecified gastrointestinal disease
  • drowsiness
  • sedation
  • fatigue
  • palpitations
  • nausea
  • sweating
  • unpleasant mood
  • irritability
  • sensory disorder
  • tremors
  • anxiety
  • confusion
  • headache
  • hypersomnia
  • emotional instability
  • insomnia
  • hypomania
  • tinnitus
  • seizures

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

reddish-brown 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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.