Brand Name: Vortaxmode Tablet.
Composition:
Each Vortaxmode 5mg tablet contains: Vortioxetine .............................................. 5 mg
Each Vortaxmode 5mg tablet contains: Vortioxetine ............................................ 10 mg
Each Vortaxmode 5mg tablet contains Vortioxetine .............................................. 15mg
Each Vortaxmode 5mg tablet contains: Vortioxetine ............................................20 mg.
Therapeutic Indications:
- is indicated for the treatment of the 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
- Vortaxmode 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 Vortaxmode formulation.
- Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with Vortaxmode or within 21 days of stopping treatment with Vortaxmode. Do not use Vortaxmode within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Vortaxmode 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 Vortaxmode, 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 Vortaxmode and initiate supportive treatment. If concomitant use of Vortaxmode with other serotonergic drugs is clinically warranted, patients should be made aware of 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 Vortaxmode is coadministered with nonsteroidal anti-inflammatory 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:
Vortaxmode 5mg Tablets: Box containing 3 blisters of 10 tablets each.
Vortaxmode 10mg Tablets: Box containing 3 blisters of 10 tablets each.
Vortaxmode 15 mg Tablets: Box containing 3 blisters of 10 tablets each.
Vortaxmode 20 mg Tablets: Box containing 3 blisters of 10 tablets each.
