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 a tablet for oral use. It is prescribed to treat major depressive disorder in adult patients.

GNH India supplies Irsamla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product meets EU quality standards and is manufactured under strict Good Manufacturing Practice guidelines. Our distribution network ensures reliable delivery to diverse healthcare settings.

Manufacturer / TM Owner

Egis Pharmaceuticals Plc

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Indications & Clinical Uses

  • Vortioxetine Hydrobromide is indicated for the treatment of major depressive disorder, a condition characterized by persistent low mood and loss of interest.
  • Major depressive disorder (acute): reduces depressive symptoms and improves mood.
  • Major depressive disorder (maintenance): helps prevent relapse of depressive episodes.
  • Major depressive disorder (cognitive symptoms): enhances concentration and cognitive function.

How It Works

  • Vortioxetine Hydrobromide inhibits the serotonin transporter, increasing synaptic serotonin, while simultaneously acting as a 5‑HT1A agonist, 5‑HT1B partial agonist, and antagonist at 5‑HT3 and 5‑HT7 receptors. This multimodal activity enhances serotonergic neurotransmission and modulates downstream neural circuits involved in mood regulation and cognition.

Side Effects

Vortioxetine Hydrobromide may cause a range of adverse reactions, some of which are common and others that are serious or rare.

Common Side Effects

  • Nausea
  • Headache
  • Dizziness
  • Constipation

Serious or Rare Side Effects

  • Serotonin syndrome (potentially life‑threatening)
  • Emergence of suicidal thoughts or behaviors
  • Severe allergic reaction such as anaphylaxis

Precautions & Warnings

  • When prescribing Vortioxetine Hydrobromide, clinicians should consider several safety aspects.
  • Pregnancy: safety not established; use only if potential benefit justifies the risk.
  • Breastfeeding: unknown excretion; weigh maternal benefit against infant risk.
  • Renal impairment: dose adjustment may be required; monitor renal function.
  • Hepatic impairment: assess liver function and consider dose modification.
  • Concomitant serotonergic agents: increased risk of serotonin syndrome; monitor closely.
  • Store at room temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Vortioxetine Hydrobromide can interact with other medicines, necessitating careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of serotonin syndrome.
  • Other serotonergic antidepressants (e.g., SSRIs, SNRIs): avoid concurrent use.
  • Triptans: may precipitate serotonin syndrome.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may increase bleeding risk.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine): may raise vortioxetine plasma levels.

Frequently Asked Questions

Irsamla contains vortioxetine hydrobromide and is used to treat major depressive disorder in adult patients. It helps alleviate depressive symptoms such as low mood, loss of interest, and associated cognitive difficulties.

Vortioxetine hydrobromide works by inhibiting the serotonin transporter, which raises serotonin levels in the brain, and by modulating several serotonin receptors (5‑HT1A agonist, 5‑HT1B partial agonist, 5‑HT3/5‑HT7 antagonist). This multimodal action enhances serotonergic neurotransmission and supports mood and cognition.

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 dosage instructions provided by their prescriber and not adjust the dose on their own.

Safety of vortioxetine hydrobromide in pregnancy and lactation has not been fully established. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and decisions should be made in consultation with a healthcare provider.

To order 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) is a serotonin modulator and stimulator, offering a broader receptor profile than traditional selective serotonin reuptake inhibitors (SSRIs). This may result in additional benefits for cognition and a different side‑effect spectrum, though individual response varies and treatment choice should be individualized.

Irsamla tablets should be stored at room temperature, below 25 °C, in the original packaging to protect them from moisture and light. Keep the product out of reach of children and do not use after the expiry date.

Irsamla is taken orally, usually once daily, with or without food, as directed by the prescriber. The tablet should be swallowed whole with water and not chewed or crushed unless otherwise instructed.

The most serious risks include the potential for serotonin syndrome, especially when combined with other serotonergic agents, and the emergence of suicidal thoughts or behaviors, particularly during early treatment or dose changes. Patients should be monitored closely for these events.

Irsamla should not be used by individuals taking monoamine oxidase inhibitors (MAOIs) or those who have had a recent MAOI therapy (within 14 days). It is also contraindicated in patients with known hypersensitivity to vortioxetine or any of its excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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