Generic
Vortioxetine Hydrobromide
14 brands available in the market
At a glance
Vortioxetine is indicated for the treatment of major depressive disorder (MDD) in adults.
Description
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).
Indications
- Major depressive disorder (MDD)
Therapeutic class
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Pharmacological class
SNRI
Pharmacology
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.
Mechanism of action
Inhibits serotonin reuptake and modulates 5-HT3 and 5-HT1A receptors, producing antidepressant effects.
Dosage
Adult Dose (Oral):
- Starting dose: 10 mg once daily, without regard to meals
- Increase to 20 mg/day, as tolerated
- Efficacy and safety of doses above 20 mg/day have not been evaluated
- A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses
- For elderly patients (>65 years), use the lowest effective dose of 5 mg/day as the starting dose
Administration
- May be taken with or without food
- Swallow tablets whole
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Hypersensitivity
- Clinical worsening and suicide risk
- Serotonin syndrome
- Abnormal bleeding
- Activation of Mania/Hypomania
- Angle closure Glaucoma
- Hyponatremia
Precautions & warnings
- Monitor appropriately for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months or at times of dose changes
- Increased risk of serotonin syndrome with serotonergic drugs
- Increased risk of bleeding with Aspirin, NSAIDs, Warfarin, and other Anticoagulants
- Use cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania
Contraindications
- Known hypersensitivity to Vortioxetine or any of the excipients
- Concomitant use of Monoamine Oxidase Inhibitors (MAOIs)
Drug interactions
- MAOIs: serious or fatal adverse reactions can develop; allow at least 21 days after stopping Vortioxetine before starting an MAOI, and at least 14 days after stopping an MAOI before starting Vortioxetine
- Serotonergic drugs (SSRIs, SNRIs, Triptans, Buspirone, Tramadol, Tryptophan): may increase serotonin toxicity or serotonin syndrome
- Strong CYP2D6 inhibitor (Bupropion, Fluoxetine, Paroxetine, Quinidine): reduce Vortioxetine dose by half
- Strong CYP inducer (Rifampin, Carbamazepine, Phenytoin): consider increasing the Vortioxetine dose
Food interactions
Food interactions are not significant.
Use in pregnancy
Use in Pregnancy: Safety not established; use only if benefits outweigh possible risks to the fetus.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Expected to be excreted into human milk; breastfeeding is not recommended during treatment.
Pediatric use
Safety and effectiveness not established in pediatric population
Geriatric use
No dose adjustment recommended on the basis of age; lowest effective dose of 5 mg/day should be used as starting dose for elderly patients (>65 years)
Renal / hepatic impairment
Renal Impairment: No dose adjustment is needed
Hepatic Impairment: Mild or moderate: no dose adjustment recommended; severe: not recommended
Overdose effects
Symptoms: Limited data available; medical follow-up in a specialized environment is recommended.
Treatment: Supportive care.
Storage conditions
Store at 30°C or below in a dry place. Keep away from light. Keep out of the reach of the children.