Posology: The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age.
Depending on the individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
Treatment discontinuation: Patients treated with Brintellix can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see Pharmacology: Pharmacodynamics under Actions).
Special population: Elderly patients: The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see Precautions).
Cytochrome P450 inhibitors: Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine) are added to Brintellix treatment (see Interactions).
Cytochrome P450 inducers: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to Brintellix treatment (see Interactions).
Paediatric population: The safety and efficacy of Brintellix in children 7 to 11 years have not been established. No data are available (see Precautions).
Brintellix should not be used in adolescents aged 12 to 17 years with major depressive disorder (MDD) because efficacy has not been demonstrated (see Pharmacology: Pharmacodynamics under Actions). The safety of Brintellix in adolescents aged 12 to 17 years is described in Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions.
Renal or hepatic impairment: No dose adjustment is needed based on renal or hepatic function (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Brintellix is for oral use.
The film-coated tablets can be taken with or without food.