Product image of Levosimendan Stada (Levosimendan) supplied by GNH India

Levosimendan Stada

Active Ingredient:
Levosimendan
Origin:
EU

Levosimendan Stada (Levosimendan)

Levosimendan, the active ingredient in Levosimendan Stada, is a calcium sensitizer / inotropic agent presented as an intravenous solution for intravenous use. It is employed to improve cardiac output in acute decompensated heart failure and may be considered in cardiogenic shock under specialist supervision.

GNH India supplies Levosimendan Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, clinics and procurement teams worldwide, with validated quality systems and regulatory approvals across the European Union. Our distribution network ensures timely delivery and compliance with local import requirements.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Levosimendan is indicated for conditions where enhanced myocardial contractility and vasodilation are required to support cardiac output.

  • Acute decompensated heart failure: improves cardiac output, reduces pulmonary capillary wedge pressure, and alleviates dyspnea and peripheral edema in patients with sudden worsening of heart function.
  • Cardiogenic shock (off‑label): provides inotropic support and vasodilation, helping to restore systemic perfusion and blood pressure when conventional catecholamine therapies are insufficient.
  • Severe low‑output heart failure: enhances myocardial contractility and reduces afterload, supporting organ perfusion in patients with refractory low‑output states.

How It Works

  • Levosimendan binds to cardiac troponin C, increasing its sensitivity to calcium and thereby augmenting contractile force without raising intracellular calcium concentration. Simultaneously it opens ATP‑sensitive potassium channels in vascular smooth muscle, producing arterial and venous vasodilation. The combined inotropic and vasodilatory actions improve cardiac output while reducing preload and afterload. These effects are dose‑dependent and persist for several hours after infusion due to an active metabolite.

Side Effects

Levosimendan may be associated with a range of adverse reactions, which are categorized by frequency and clinical significance.

Common Side Effects

  • Hypotension: transient drop in blood pressure, especially during initial infusion.
  • Headache: mild to moderate headache reported during treatment.
  • Nausea: occasional nausea or vomiting.
  • Tachycardia: increase in heart rate observed in some patients.

Serious or Rare Side Effects

  • Severe hypotension: profound blood pressure fall requiring vasopressor support.
  • Ventricular arrhythmias: life‑threatening cardiac rhythm disturbances.
  • Anaphylactic reaction: rare hypersensitivity with rash, bronchospasm, or shock.

Precautions & Warnings

When using Levosimendan, clinicians should observe specific precautions to minimize risk and ensure safe administration.

  • Cardiovascular monitoring: continuous blood pressure and ECG monitoring during infusion.
  • Concomitant vasodilators: avoid simultaneous high‑dose nitrates or phosphodiesterase inhibitors to prevent excessive hypotension.
  • Electrolyte balance: correct hypokalemia or hypomagnesemia before starting therapy.
  • Renal or hepatic impairment: adjust dosing or monitor closely in patients with severe organ dysfunction.
  • Recent myocardial infarction: use with caution in patients who have had an MI within the past 30 days.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Levosimendan can interact with other medicines, influencing its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase plasma concentrations and risk of hypotension.
  • Concurrent potent vasodilators (e.g., nitroprusside, high‑dose nitrates): can cause severe hypotension.
  • Other inotropic agents (e.g., dobutamine, milrinone): may predispose to arrhythmias.

Moderate Interactions (Monitor Closely)

  • Diuretics: may exacerbate electrolyte disturbances, enhancing risk of arrhythmias.
  • Beta‑blockers: may blunt the inotropic response, requiring dose adjustment.
  • Anticoagulants: additive effect on bleeding risk should be monitored.

Frequently Asked Questions

Levosimendan Stada is used in the hospital setting to support patients with acute decompensated heart failure and, on an off‑label basis, in cardiogenic shock. It works by improving cardiac contractility and reducing vascular resistance, helping to restore adequate circulation.

Levosimendan enhances the sensitivity of cardiac troponin C to calcium, which increases contractile force without raising intracellular calcium levels. It also opens ATP‑sensitive potassium channels in vascular smooth muscle, causing arterial and venous vasodilation that lowers preload and afterload.

The dose of Levosimendan Stada is determined by the prescribing physician based on the patient’s clinical condition, severity of heart failure, and response to therapy. Dosing regimens are individualized and should follow the product’s prescribing information.

Safety data for levosimendan in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies any potential risk to the fetus or infant.

To order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if required) and import documentation.

Unlike catecholamine inotropes, levosimendan increases contractility without raising intracellular calcium, which may reduce the risk of calcium‑mediated arrhythmias. It also provides vasodilation through potassium‑channel activation, offering combined inotropic and afterload‑reducing effects that differ from agents such as dobutamine or milrinone.

Levosimendan Stada should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. The solution should be kept in its original packaging until use and inspected for particulate matter before administration.

Levosimendan Stada is given as an intravenous infusion under continuous medical supervision. The infusion rate and duration are set by the treating physician, with regular monitoring of blood pressure, heart rate and ECG throughout the administration.

The most serious risks include severe hypotension that may require vasopressor support, life‑threatening ventricular arrhythmias, and rare anaphylactic reactions. Prompt recognition and management of these events are essential during infusion.

Levosimendan is contraindicated in patients with known hypersensitivity to the drug, uncontrolled severe hypotension, or those receiving other potent vasodilators that could precipitate dangerous blood pressure drops. Caution is also advised in recent myocardial infarction, severe renal or hepatic impairment, and in pregnant or nursing women unless clearly indicated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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