Product image of Levosimendán Sala (Levosimendan) supplied by GNH India

Levosimendán Sala

Active Ingredient:
Levosimendan
Origin:
EU

Levosimendán Sala (Levosimendan)

Levosimendan, the active ingredient in Levosimendán Sala, is a calcium sensitizer / inodilator presented as a solution for injection for intravenous use. It treats acute decompensated heart failure in hospitalized patients by improving cardiac contractility and reducing vascular resistance, thereby enhancing cardiac output and relieving symptoms of congestion.

GNH India supplies Levosimendán Sala as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and clinics worldwide.

Manufacturer / TM Owner

Laboratorio Reig Jofre, S.A.

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Indications & Clinical Uses

Levosimendan is used in the management of acute decompensated heart failure, a condition characterized by sudden worsening of cardiac function.

  • Acute decompensated heart failure: improves cardiac output and reduces symptoms of congestion.
  • Severe chronic heart failure (as adjunctive therapy): provides hemodynamic support when standard treatments are insufficient.
  • Peri‑operative cardiac support in high‑risk cardiac surgery: stabilises haemodynamics during and after the procedure.

How It Works

  • Levosimendan increases myocardial contractility by binding to troponin C and sensitising it to calcium, which enhances the force of contraction without raising intracellular calcium levels. Simultaneously, it opens ATP‑sensitive potassium channels in vascular smooth muscle, causing vasodilation of both arterial and venous beds, which reduces preload and afterload.

Side Effects

Levosimendan may be associated with several adverse reactions.

Common Side Effects

  • Hypotension: reduction in blood pressure, especially after loading dose.
  • Headache: mild to moderate intensity.
  • Nausea: occasional gastrointestinal upset.
  • Tachycardia: increased heart rate.
  • Dizziness: feeling of light‑headedness.
  • Arrhythmias: premature beats or mild rhythm disturbances.

Serious or Rare Side Effects

  • Severe hypotension: marked drop in blood pressure requiring intervention.
  • Ventricular arrhythmias: potentially life‑threatening rhythm disorders.
  • Myocardial ischemia: chest pain due to reduced coronary perfusion.
  • Pulmonary edema: fluid accumulation in lungs.
  • Anaphylactic reaction: rare allergic response.
  • Liver enzyme elevation: significant increase in transaminases.

Precautions & Warnings

Levosimendan requires careful monitoring and specific safety measures.

  • Blood pressure monitoring: check regularly to detect hypotension.
  • Cardiac rhythm observation: continuous ECG to identify arrhythmias.
  • Contraindication in severe hypotension: avoid use when systolic pressure is <90 mmHg.
  • Caution in renal or hepatic impairment: dose adjustment may be needed.
  • Interaction with other vasodilators: assess risk of additive blood‑pressure effects.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Levosimendan can interact with several drug classes, requiring vigilance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase levosimendan plasma levels.
  • Strong CYP2D6 inhibitors (e.g., quinidine, paroxetine): can elevate active metabolite concentrations.
  • Concurrent potent vasodilators (e.g., nitroglycerin, hydralazine): risk of severe hypotension.

Moderate Interactions (Monitor Closely)

  • Diuretics: may potentiate volume depletion and hypotension.
  • ACE inhibitors or ARBs: additive blood‑pressure lowering effect.
  • Beta‑blockers: may blunt desired inotropic response.
  • Anti‑arrhythmic agents: monitor for rhythm changes.
  • Anticoagulants: observe for bleeding if hypotension occurs.

Frequently Asked Questions

Levosimendán Sala contains levosimendan, which is indicated for the short‑term intravenous treatment of acute decompensated heart failure. It helps improve cardiac output and relieve symptoms such as breathlessness and fluid overload in hospitalized patients.

Levosimendan works by sensitising cardiac troponin C to calcium, enhancing contractile force without increasing intracellular calcium. It also opens ATP‑sensitive potassium channels in vascular smooth muscle, producing arterial and venous vasodilation that lowers preload and afterload.

The dosing regimen for Levosimendán Sala is determined by the prescribing clinician based on the patient’s clinical status, weight, and renal/hepatic function. The prescriber sets the infusion rate and duration according to approved guidelines.

The safety of levosimendan in pregnancy and lactation has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by the treating physician.

To place an order, 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 (including cold‑chain if needed) and import documentation.

Unlike traditional catecholamine inotropes, levosimendan increases contractility without raising intracellular calcium, which may reduce the risk of arrhythmias. Its combined vasodilatory effect also lowers cardiac workload, offering a distinct pharmacological profile compared with agents such as dobutamine or milrinone.

Levosimendán Sala should be stored at 2‑8 °C in a refrigerator, protected from light. Do not freeze or shake the solution. Before use, allow the product to reach room temperature if required, and inspect for particulate matter or discoloration.

Levosimendán Sala is given as an intravenous infusion. A typical regimen starts with a loading dose followed by a continuous maintenance infusion, administered under close haemodynamic monitoring in a hospital setting.

The most serious risks include severe hypotension, ventricular arrhythmias, myocardial ischemia, and rare anaphylactic reactions. Continuous blood‑pressure and ECG monitoring during infusion helps detect and manage these events promptly.

Levosimendán Sala is contraindicated in patients with systolic blood pressure below 90 mmHg, severe obstructive cardiomyopathy, or known hypersensitivity to levosimendan or any excipients. Caution is also advised in individuals with significant renal or hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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