Europe — EMA
Irsamla (Vortioxetine Hydrobromide)
GNH USA supplies Irsamla (Vortioxetine), a serotonin modulator and stimulator for major depressive disorder. Request a quote for global supply.
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What is 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 adults.
GNH USA supplies Irsamla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Vortioxetine Hydrobromide used for?
Irsamla (vortioxetine) acts on serotonergic pathways to alleviate depressive symptoms.
Major Depressive Disorder: reduces depressive symptoms and improves functional outcomes in adult patients.
What are the side effects of Vortioxetine Hydrobromide?
Vortioxetine may cause a range of adverse reactions, from mild to serious.
Common Side Effects: - Nausea - Headache - Dizziness - Dry mouth - Constipation - Insomnia
Serious or Rare Side Effects: - Serotonin syndrome - Suicidal thoughts or behavior - Severe hyponatremia - Allergic reactions (rash, angioedema) - QT interval prolongation
What precautions apply to Vortioxetine Hydrobromide?
When prescribing Irsamla, clinicians should consider several safety measures. - Suicidal risk assessment: monitor patients for emergent suicidal thoughts, especially early in therapy. - Serotonin syndrome: avoid concurrent use of other serotonergic agents. - Hepatic impairment: dose adjustment may be required in moderate to severe liver disease. - Discontinuation: taper gradually to reduce withdrawal symptoms. - MAO inhibitor use: ensure a minimum 14‑day washout period before initiating vortioxetine. - Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Vortioxetine Hydrobromide interact with?
Vortioxetine can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Monoamine oxidase inhibitors (MAOIs): risk of serotonin syndrome. - Linezolid or other reversible MAO‑A inhibitors. - Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase vortioxetine exposure.
Moderate Interactions (Monitor Closely): - CYP2D6 substrates (e.g., tamoxifen): possible altered efficacy. - NSAIDs or anticoagulants: increased bleeding risk. - Alcohol: may exacerbate central nervous system effects. - Antihistamines with serotonergic activity: monitor for additive side effects.



