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

Irsamla

Active Ingredient:
Vortioxetine Hydrobromide
Origin:
EU

Irsamla (Vortioxetine Hydrobromide)

Vortioxetine Hydrobromide, the active ingredient in Irsamla, is a serotonin modulator and stimulator presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients, helping to improve mood and functional outcomes.

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 global distribution for regulated medicines. Customers benefit from comprehensive regulatory support and timely delivery across multiple regions.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

Vortioxetine Hydrobromide (Irsamla) is used in the management of depressive disorders by modulating serotonergic neurotransmission.

  • Major depressive disorder: reduces depressive symptoms and improves functional recovery.

How It Works

  • Vortioxetine Hydrobromide acts as a serotonin modulator and stimulator; it antagonizes 5‑HT3, 5‑HT7, and 5‑HT1D receptors, agonizes 5‑HT1A receptors, and inhibits the serotonin transporter, thereby enhancing serotonergic neurotransmission across multiple pathways.

Side Effects

Common Side Effects

  • Nausea
  • Headache
  • Dizziness
  • Dry mouth

Serious or Rare Side Effects

  • Serotonin syndrome
  • Suicidal thoughts or behavior
  • Severe hyponatremia
  • Allergic reactions such as rash or angioedema

Precautions & Warnings

Before initiating therapy, assess psychiatric history and evaluate risk of suicidal ideation.

  • Monitor for serotonin syndrome: watch for agitation, hyperreflexia, fever.
  • Avoid abrupt discontinuation: taper under medical supervision.
  • Use caution in hepatic impairment: consider dose adjustment.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Vortioxetine may interact with several drug classes.

Major Interactions (Avoid)

  • MAO inhibitors: concurrent use can precipitate serotonin syndrome.
  • Other serotonergic agents (SSRIs, SNRIs, tramadol): increased risk of serotonin syndrome.
  • Linezolid: avoid due to MAO inhibition.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase vortioxetine plasma levels.
  • CYP3A4 inducers (e.g., carbamazepine, phenytoin): may reduce therapeutic efficacy.
  • Anticoagulants (e.g., warfarin): monitor INR and bleeding risk.

Frequently Asked Questions

Irsamla contains vortioxetine hydrobromide and is prescribed for the treatment of major depressive disorder in adult patients. It helps alleviate depressive symptoms and can improve overall functional outcomes by enhancing serotonergic activity in the brain.

Vortioxetine acts as a serotonin modulator and stimulator. It blocks several serotonin receptors, stimulates the 5‑HT1A receptor, and inhibits the serotonin transporter, resulting in increased serotonin availability and balanced neurotransmission across multiple pathways.

The appropriate dose of Irsamla is determined by the prescribing healthcare professional based on the individual’s clinical condition, response, and tolerability. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for vortioxetine in pregnancy and lactation are limited. The prescriber will weigh potential benefits against possible risks to the fetus or infant before deciding to use Irsamla in these populations.

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

Irsamla (vortioxetine) differs from traditional SSRIs by also modulating multiple serotonin receptors, which may offer benefits for cognition and fewer sexual side effects. However, individual response varies, and the choice of antidepressant should be guided by the prescriber based on patient profile and tolerability.

Store Irsamla at ambient temperature, below 25 °C, in the original packaging. Protect the tablets from moisture, heat, and direct sunlight to maintain stability and potency throughout its shelf life.

Irsamla is taken orally as a tablet, usually once daily. It can be swallowed with or without food, but patients should follow the specific instructions provided by their healthcare professional.

Serious risks include serotonin syndrome, emergence of suicidal thoughts or behaviors, severe hyponatremia, and allergic reactions such as rash or angioedema. Patients should seek immediate medical attention if they experience any of these symptoms.

Irsamla should not be used by individuals currently taking monoamine oxidase inhibitors (MAOIs) or those with known hypersensitivity to vortioxetine or any tablet excipients. Caution is also advised in patients with severe hepatic impairment or a history of serotonin syndrome.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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