VORITINE 10

Indications

• Major depressive disorder (MDD) in adults

Dosage

Children: Refer to specific dosing guidelines from medical literature or prescribing information.

Adults: Refer to specific dosing guidelines from medical literature or prescribing information.

Mechanism of action

Vortioxetine acts as a selective serotonin reuptake inhibitor (SSRI) and has additional actions as a serotonin receptor modulator. It inhibits the serotonin transporter (SERT), leading to increased levels of serotonin in the synaptic cleft. Moreover, it acts as an agonist at the 5-HT1A receptor and as an antagonist at several other serotonin receptors, including 5-HT3, 5-HT7, and 5-HT1B. This multifaceted approach is thought to enhance its therapeutic effects while minimizing side effects associated with traditional SSRIs.

Pharmacodynamics

The pharmacodynamic profile of vortioxetine includes its ability to enhance serotonin neurotransmission, which is crucial in alleviating symptoms of depression. By acting on multiple serotonin receptors, vortioxetine may also improve cognitive function and reduce anxiety symptoms often associated with depression. The drug's unique receptor profile is believed to confer an improved tolerability and a favorable side effect profile compared to other antidepressants.

Pharmacokinetics

Vortioxetine is well-absorbed following oral administration, with peak plasma concentrations occurring approximately 7.5 hours after dosing. It has a half-life of about 66 hours, allowing for once-daily dosing. The drug is extensively metabolized in the liver primarily via cytochrome P450 enzymes, particularly CYP2D6, and is excreted mainly in the urine. Renal impairment does not significantly affect the drug's pharmacokinetics, but caution is advised in patients with hepatic impairment.

Contra-indications

• Hypersensitivity to voritoxetine or any of its components
• Use in combination with monoamine oxidase inhibitors (MAOIs)
• Concomitant use with other serotonergic drugs

Adverse effects

• Nausea
• Diarrhoea
• Dizziness
• Dry mouth
• Constipation
• Fatigue
• Insomnia
• Sexual dysfunction

Interactions

• Increased risk of serotonin syndrome when used with other serotonergic drugs
• Caution with drugs that affect CYP2D6 metabolism
• Avoid concomitant use with MAOIs

Precautions

• Monitor for signs of serotonin syndrome
• Use with caution in patients with a history of seizures
• Gradual withdrawal recommended to avoid discontinuation syndrome
• Assess risk of bleeding when used with anticoagulants

Pregnancy

Limited data on the use of voritoxetine in pregnancy. Use only if potential benefits justify the potential risks to the fetus.

Breast-feeding

Voritoxetine is excreted in breast milk. Caution should be exercised when administered to nursing women.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

• Oral tablets
• 10 mg, 20 mg, 40 mg strengths