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Pharmaceutical

Product Details:

Brand Name: Vortixamode 5mg , 10mg , 15mg , 20mg Tablet

Composition

 

Each Vortixamode tablet contains: 

Vortioxetine 5mg , 10mg , 15mg , 20mg

Therapeutic Indications

  •  is indicated for the treatment of major depressive disorder (MDD)

Dosage and Administration

  • The recommended starting dose is 10 mg administered orally once daily without regard to meals .
  • The dose should then be increased to 20 mg/day, as tolerated
  • Consider 5 mg/day for patients who do not tolerate higher doses
  • Vortixamode can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible
  • The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers

Contraindications

  • Hypersensitivity to vortioxetine or any components of the Vortixamode formulation .
  • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with Vortixamode or within 21 days of stopping treatment with Vortixamode. Do not use Vortixamode within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Vortixamode in a patient who is being treated with linezolid or intravenous methylene blue

Warnings and precautions

  • Serotonin Syndrome has been reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with Vortixamode, both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort). If such symptoms occur, discontinue Vortixamode and initiate supportive treatment. If concomitant use of Vortixamode with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases .
  •  Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when Vortixamode is coadministered with nonsteroidal antiinflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation .
  • Activation of Mania/Hypomania can occur with antidepressant treatment. Screen patients for bipolar disorder .
  •  Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Undesirable Effects

  • Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting

Pharmacological Properties

The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS 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. The contribution of these activities to vortioxetine’s antidepressant effect has not been established.

Packaging

Vortixamode 5mg Tablets: Box containing 3 blisters of 10 tablets each