Vintelix

Approved Indications:

• Major Depressive Disorder (MDD) in adults: Vortioxetine is approved for the treatment of major depressive disorder, including moderate to severe forms.

Off-label (Clinically Accepted) Uses:

• Generalized Anxiety Disorder (GAD): Occasionally used when first-line SSRIs or SNRIs are ineffective.
• Cognitive impairment associated with depression: Vortioxetine has demonstrated benefits in improving cognitive dysfunction in patients with MDD.
• Chronic fatigue syndrome (CFS) (investigational use): Due to its effects on mood and cognitive function.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults:

• Initial dose: 10 mg orally once daily.
• Maintenance dose: 10 to 20 mg once daily.
• Maximum dose: 20 mg/day.
• Dose adjustments: If 10 mg is not tolerated, reduce to 5 mg once daily.

Elderly:

• Initiate at 5 mg once daily.
• Dose escalation should be cautious due to potential increased sensitivity.

Pediatrics:

• Safety and efficacy not established in individuals under 18 years.

Renal Impairment:

• No dosage adjustment necessary in mild, moderate, or severe renal impairment.

Hepatic Impairment:

• No dosage adjustment required for mild to moderate impairment. Use cautiously in severe impairment (data limited).

Administration:

• Route: Oral.
• Can be taken with or without food.
• Should be continued for several months after symptom improvement for maintenance.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Vortioxetine is a multimodal antidepressant. It acts as a serotonin (5-HT) reuptake inhibitor and modulates several 5-HT receptors. Specifically, it inhibits the serotonin transporter (SERT), is an agonist at 5-HT1A receptors, partial agonist at 5-HT1B, and antagonist at 5-HT3, 5-HT1D, and 5-HT7 receptors. This broad receptor activity increases serotonin availability in the synaptic cleft and modulates multiple neurotransmitter systems including norepinephrine, dopamine, acetylcholine, and histamine, contributing to its antidepressant and procognitive effects.

• Absorption: Well absorbed orally; absolute bioavailability ~75%.
• Peak plasma concentration (Tmax): ~7–11 hours post-dose.
• Distribution: Volume of distribution ~2,600 L; highly protein-bound (~98–99%).
• Metabolism: Extensively metabolized in the liver, primarily via CYP2D6, and to a lesser extent CYP3A4/5 and CYP2C9.
• Active Metabolites: None with pharmacological activity.
• Elimination half-life: ~66 hours (prolonged in poor metabolizers).
• Excretion: Primarily in urine (~59%) and feces (~26%), mostly as metabolites.

• Pregnancy: No FDA pregnancy category (new labeling rule). Limited data in human pregnancy. Animal studies show adverse effects on fetal development at high doses. Use only if the potential benefit justifies the risk.
• Lactation: Vortioxetine is excreted in human breast milk in small amounts. Effects on the breastfed infant are unknown. Caution is advised.
• Recommendation: Use during pregnancy and breastfeeding only if clearly needed. Monitor neonates for withdrawal symptoms or serotonin syndrome if exposed late in pregnancy.

• Primary Class: Antidepressant
• Subclass: Serotonin Modulator and Stimulator (SMS)
• Generation: New-generation antidepressant (distinct from SSRI/SNRI classes)

• Known hypersensitivity to vortioxetine or any excipient.
• Concomitant use with MAO inhibitors (MAOIs) or within 14 days of stopping an MAOI.
• Initiation of MAOIs within 21 days of discontinuing vortioxetine.

• Suicidal thoughts and behavior: Increased risk, especially in young adults under 25. Close monitoring required during initiation and dose changes.
• Serotonin Syndrome: Can occur with concomitant serotonergic drugs (e.g., triptans, SSRIs, SNRIs, tramadol, etc.).
• Mania/hypomania: May be triggered in patients with bipolar disorder.
• Seizures: Use with caution in individuals with seizure history.
• Bleeding risk: Increased when used with NSAIDs, aspirin, or other anticoagulants.
• Hyponatremia: Reported especially in elderly patients.
• Clinical monitoring: Monitor for mood changes, agitation, emergence of suicidal ideation, especially during the first few weeks of therapy.

Common (≥1%):

• Central Nervous System: Nausea, dizziness, dry mouth, headache, insomnia, abnormal dreams.
• Gastrointestinal: Diarrhea, constipation, vomiting.
• Psychiatric: Anxiety, agitation.
• Others: Sexual dysfunction, fatigue.

Serious or Rare:

• Hyponatremia/SIADH
• Serotonin syndrome
• Seizures
• Angle-closure glaucoma (rare)
• Manic episodes

Timing & Dose-dependence:

• Most common side effects (e.g., nausea) occur within the first week and are dose-related.
• Usually mild to moderate in severity and self-limiting.

• MAOIs: Contraindicated due to risk of serotonin syndrome.
• Serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, lithium): Risk of serotonin syndrome.
• CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine): May increase vortioxetine levels.
• CYP inducers (e.g., rifampin, carbamazepine): May decrease vortioxetine levels; dosage adjustment may be needed.
• Anticoagulants/antiplatelets/NSAIDs: Increased bleeding risk.
• Alcohol: Use cautiously; additive CNS depression possible.

Enzyme systems involved:

• Metabolized mainly by CYP2D6, also CYP3A4 and CYP2C9.

• FDA & EMA: Emphasize monitoring for suicidal ideation in young adults; no major changes in indication since initial approval.
• APA Guidelines (2023): Recognize vortioxetine as a treatment option in MDD with prominent cognitive symptoms.
• Recent trials: Continued evidence supports its procognitive effects and minimal sexual dysfunction compared to other antidepressants.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C.
• Humidity: Protect from excessive moisture.
• Light: Store in original packaging to protect from light.
• Handling: No special handling precautions required. No need for refrigeration or reconstitution.