Product image of Irsamla (Vortioxetine Hydrobromide) supplied by GNH India

Irsamla

Active Ingredient:
Vortioxetine Hydrobromide
Origin:
EU

Irsamla (Vortioxetine Hydrobromide)

Vortioxetine, the active ingredient in Irsamla, is a serotonin modulator and stimulator presented as an oral tablet for oral use. It is prescribed for the treatment of major depressive disorder in adult patients. It is indicated for patients who require a novel approach to serotonin modulation.

GNH India supplies Irsamla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable sourcing for regulated markets. Our distribution network ensures timely delivery and compliance with local regulatory requirements.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

  • Vortioxetine acts on the serotonergic system and is approved for the treatment of major depressive disorder.
  • Major depressive disorder: reduces depressive symptoms and improves overall mood in adult patients.

How It Works

  • Vortioxetine modulates multiple serotonin receptors (5‑HT1A agonist, 5‑HT1B partial agonist, 5‑HT3/5‑HT7 antagonist) while inhibiting the serotonin transporter, leading to increased extracellular serotonin and enhanced serotonergic neurotransmission throughout the central nervous system.

Side Effects

Vortioxetine may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Nausea
  • Headache
  • Dizziness
  • Dry mouth

Serious or Rare Side Effects

  • Serotonin syndrome
  • Suicidal thoughts or behavior
  • Severe allergic reaction (anaphylaxis)

Precautions & Warnings

  • When prescribing Vortioxetine, clinicians should consider several safety precautions.
  • Monitor for worsening depression: assess suicidal ideation regularly.
  • Assess hepatic function: dose adjustment may be needed in severe liver impairment.
  • Avoid abrupt discontinuation: taper gradually to reduce withdrawal symptoms.
  • Use with caution in the elderly: increased sensitivity to side effects.
  • Store at room temperature: keep in the original container, protect from moisture.

Avoid Interactions

Vortioxetine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs) within 14 days
  • Other serotonergic agents (SSRIs, SNRIs, tramadol, linezolid)
  • St. John’s wort
  • Strong CYP2D6 inhibitors

Moderate Interactions (Monitor Closely)

  • CYP2D6 substrates (e.g., metoprolol)
  • NSAIDs (increased bleeding risk)
  • Antihypertensive agents (possible blood pressure changes)

Frequently Asked Questions

Irsamla contains vortioxetine, which is prescribed to treat major depressive disorder in adult patients. It works by enhancing serotonergic activity in the brain, helping to alleviate depressive symptoms.

Vortioxetine modulates several serotonin receptors and blocks the serotonin transporter, resulting in increased serotonin levels and improved neurotransmission across multiple pathways involved in mood regulation.

The appropriate dose of Irsamla is determined by the prescribing clinician based on the patient’s condition, response, and tolerability. Dosage adjustments are made according to individual therapeutic needs.

The safety of vortioxetine in pregnancy and lactation has not been fully established. Clinicians should weigh potential benefits against risks and consider alternative treatments when treating pregnant or nursing individuals.

To request Irsamla, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and necessary import documentation.

Compared with traditional SSRIs, vortioxetine offers a broader mechanism by targeting multiple serotonin receptors in addition to reuptake inhibition, which may result in a different side‑effect profile and potential benefits for cognitive symptoms.

Irsamla should be stored at room temperature, below 25 °C, in its original packaging. Protect the tablets from moisture and keep them out of direct sunlight to maintain stability.

Irsamla is taken orally, usually once daily with or without food, as directed by the prescribing healthcare professional.

Serious risks include the potential for serotonin syndrome, emergence of suicidal thoughts or behaviors, and severe allergic reactions such as anaphylaxis. Patients should seek immediate medical attention if these occur.

Irsamla is contraindicated in patients currently taking monoamine oxidase inhibitors, those with known hypersensitivity to vortioxetine, and individuals with a history of severe serotonin syndrome.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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