Vortixen

Brintexa is indicated for the treatment of major depressive disorder (MDD) in adults.

Recommended dose
: The recommended starting dose is 10 mg administered orally once daily without regard to meals. The dosage should then be increased to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses. The lowest effective dose of 5 mg/day should always be used as the starting dose for elderly patients (>65 years of age).
Maintenance dose
: For MDD, Vortioxetine can be administered for several months or longer. For a long period use patients should be re-evaluated to assess the usefulness of the drugs for individual patients.
Discontinuation treatment
: Although Vortioxetine can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of Vortioxetine 15 mg/day or 20 mg/day. To avoid these adverse reactions, it is recommended that the dose should be decreased to 10 mg/day for one week before full discontinuation of Vortioxetine 15 mg/day or 20 mg/day.
Switching a patient to or from a Monoamine Oxidase Inhibitor (MAOI) intended to treat Psychiatric Disorders
: At least 14 days must elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Vortioxetine to avoid the risk of Serotonin Syndrome. Conversely, at least 21 days must elapse after stopping Vortioxetine before starting an MAOI intended to treat psychiatric disorders.

Patients taking Brintexa may experience some adverse events such as Hypersensitivity, Clinical worsening and suicide risk, Serotonin syndrome, Abnormal bleeding, activation of Mania/Hypomania, Angle closure Glaucoma, Hyponatremia.

Clinical Worsening and Suicide Risk
: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Serotonin Syndrome
: The development of a potentially life-threatening serotonin syndrome has been reported with serotonergic antidepressants including Brintexa, when used alone but more often when used concomitantly with other serotonergic drugs (including Triptans, Tricyclic Antidepressants, Fentanyl, Lithium, Tramadol, Tryptophan, Buspirone & St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as Linezolid and intravenous methylene blue).
Abnormal Bleeding
: The use of drugs that interfere with serotonin reuptake inhibition, including Brintexa, may increase the risk of bleeding events. Concomitant use of Aspirin, Nonsteroidal
Anti-inflammatory drugs (NSAIDs), Warfarin, and other Anticoagulants may add to this risk. Activation of
Mania/Hypomania
: As with all Antidepressants, use Brintexa cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.
Angle Closure Glaucoma
: The pupillary dilation that occurs following the use of many Antidepressant drugs, including Brintexa, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hyponatremia
: Hyponatremia occurrs because of treatment with serotonergic drugs.

The mechanism of the antidepressant effect of Vortioxetine is not fully understood, but it is thought to be related to its enhancement of serotonergic activity in the central nervous system through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism.