Vintelix 5 Tablet

Generic Name: Vortioxetine Hydrobromide

Strength: 5 mg

Presentation: Tablet

Manufacturer: Beximco Pharmaceuticals Ltd.

Indications:

• Treatment of major depressive disorder (MDD) in adults.

Pharmacology:

• The mechanism of the antidepressant effect of Vortioxetine is not fully understood.

• 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).

• Vortioxetine also has other activities, including 5-HT3 receptor antagonism and 5-HT1A receptor agonism.

Dosage and Administration:

• Recommended starting dose: 10 mg administered orally once daily, without regard to meals.

• Dosage may be increased to 20 mg/day, as tolerated.

• 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: Vortioxetine can be administered for several months or longer. For long-term use, patients should be re-evaluated to assess the continued usefulness of the drug.

• Discontinuation: Although Vortioxetine can be abruptly discontinued, patients may experience transient adverse reactions such as headache and muscle tension following abrupt discontinuation of Vortioxetine 15 mg/day or 20 mg/day. To avoid these reactions, it is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of Vortioxetine 15 mg/day or 20 mg/day.

• Switching from a Monoamine Oxidase Inhibitor (MAOI) intended to treat Psychiatric Disorders:

  • At least 14 days must elapse between discontinuation of an MAOI 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.

Contraindications:

• Hypersensitivity to Vortioxetine or any of the excipients of the drug product.

• Concomitant use of Monoamine Oxidase Inhibitors (MAOIs).

Warnings and Precautions:

• Suicidal Thoughts and Behaviors: Antidepressants may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Monitor all patients for any reason.

• Serotonin Syndrome: Potentially life-threatening condition.

• Abnormal Bleeding: May increase the risk of bleeding events.

• Activation of Mania/Hypomania: Use with caution in patients with a history of mania.

• Angle Closure Glaucoma: May trigger an angle closure attack in patients with untreated angle closure glaucoma.

• Hyponatremia: May occur as a result of treatment with SSRIs and SNRIs, including vortioxetine.

Drug Interactions:

• Monoamine Oxidase Inhibitors (MAOIs): Increased risk of serious, sometimes fatal, reactions.

• Serotonergic Drugs: Co-administration with other drugs that affect serotonergic neurotransmission (e.g., SSRIs, SNRIs, triptans) may increase the risk of serotonin syndrome.

• Other CNS Active Agents:

  • Lithium: No clinically relevant effect was observed on steady-state Lithium exposure following co-administration with multiple daily doses of Vortioxetine.

• Potential for other drugs to affect Vortioxetine:

  • Reduce Vortioxetine dose by half when a strong CYP2D6 inhibitor (e.g., Bupropion, Fluoxetine, Paroxetine, Quinidine) is co-administered.

  • Consider increasing the Vortioxetine dose when a strong CYP inducer (e.g., Rifampin, Carbamazepine, Phenytoin) is co-administered.

  • The effect of smoking on vortioxetine plasma concentrations has not been specifically studied.

Common Side Effects:

• Nausea