Details

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• Active Ingredient: Vortioxetine hydrobromide 10 mg per tablet.

• Registration Number (MAL): MAL15045160AZ.

• Manufacturer: H. Lundbeck A/S, Valby, Denmark.

• Registration Holder: Lundbeck Malaysia Sdn. Bhd., Petaling Jaya, Selangor, Malaysia.

• Importer: Zuellig Pharma Sdn. Bhd., Shah Alam, Selangor, Malaysia.
  
   

  Indications

• Treatment of major depressive episodes in adults.

• May be used as monotherapy or adjunctive therapy in combination with other antidepressants.

• Effectiveness has been demonstrated in clinical trials

 

Instructions for Use

• Dosage: The starting and recommended dose is 10 mg once daily in adults under 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg or decreased to a minimum of 5 mg once daily.

• Administration: Brintellix can be taken with or without food.

• Special Populations:

  • Elderly (≥65 years): The lowest effective dose of 5 mg once daily should always be used as the starting dose.

  • Cytochrome P450 inhibitors: If strong CYP2D6 inhibitors (e.g., bupropion, quinidine, fluoxetine, paroxetine) are added to Brintellix treatment, a lower dose may be considered.

  • Cytochrome P450 inducers: If a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to Brintellix treatment, a dose adjustment may be considered.