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

Levosimendan Bioglan

Active Ingredient:
Levosimendan
Origin:
EU

Levosimendan Bioglan (Levosimendan)

Levosimendan, the active ingredient in Levosimendan Bioglan, is a calcium sensitizer presented as an injectable solution for intravenous use. It enhances myocardial contractility while reducing afterload, making it suitable for the treatment of acute decompensated heart failure and cardiogenic shock in hospitalized patients who require rapid hemodynamic support.

GNH India supplies Levosimendan Bioglan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, and clinics worldwide. The company adheres to EU quality standards, provides full regulatory documentation, and offers temperature‑controlled logistics to ensure product integrity from manufacturing to end‑user.

Manufacturer / TM Owner

Bioglan Ab

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Indications & Clinical Uses

  • Levosimendan is employed in the management of acute cardiac failure states where enhanced contractility and vasodilation are required.
  • Acute decompensated heart failure: improves cardiac output and reduces pulmonary congestion, helping stabilize patients awaiting further therapy.
  • Cardiogenic shock: provides inotropic support while lowering systemic vascular resistance, facilitating blood pressure recovery in critically ill patients.
  • Low‑output heart failure after cardiac surgery: stabilizes hemodynamics and may aid weaning from mechanical circulatory support.

How It Works

  • Levosimendan binds to cardiac troponin C in a calcium‑dependent manner, increasing the sensitivity of the contractile apparatus to existing intracellular calcium without raising calcium levels. Simultaneously, it opens ATP‑sensitive potassium channels in vascular smooth muscle, producing peripheral vasodilation and reducing afterload. These combined actions enhance myocardial contractility while improving systemic circulation. The drug’s effect is independent of β‑adrenergic receptors, allowing use in patients receiving β‑blockade.

Side Effects

Levosimendan may be associated with several adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Hypotension: drop in blood pressure due to vasodilation.
  • Headache: mild to moderate cephalic discomfort.
  • Nausea: gastrointestinal upset.
  • Tachycardia: increased heart rate.

Serious or Rare Side Effects

  • Ventricular arrhythmias: potentially life‑threatening rhythm disturbances.
  • Myocardial ischemia: chest pain or ECG changes indicating reduced coronary perfusion.
  • Severe hypotension: profound blood pressure fall requiring intervention.

Precautions & Warnings

When using Levosimendan, clinicians should consider several precautionary measures to minimize risk.

  • Cardiac arrhythmias: monitor ECG continuously for new or worsening arrhythmias.
  • Hypotension: assess blood pressure before and during infusion; adjust dose if needed.
  • Renal impairment: use with caution in patients with reduced renal function, as clearance may be affected.
  • Hepatic dysfunction: dose adjustment may be required in severe liver disease.
  • Pregnancy and lactation: safety not established; avoid use unless benefit outweighs potential risk.
  • 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)

  • Concomitant vasodilators (e.g., nitroglycerin): may cause severe hypotension.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase levosimendan plasma levels.
  • Other inotropes (e.g., dobutamine, milrinone): risk of excessive cardiac stimulation.

Moderate Interactions (Monitor Closely)

  • Beta‑blockers: may blunt the inotropic response.
  • Diuretics: can exacerbate hypotension if volume depletion occurs.
  • ACE inhibitors or ARBs: additive blood pressure‑lowering effect.
  • Calcium channel blockers: may affect vascular tone and interact with potassium channel activity.

Frequently Asked Questions

Levosimendan Bioglan is indicated for the short‑term treatment of acute decompensated heart failure and cardiogenic shock in hospitalized patients. It provides inotropic support and reduces afterload, helping to stabilize hemodynamics while other definitive therapies are being arranged.

Levosimendan sensitises cardiac troponin C to calcium, which enhances the strength of myocardial contraction without increasing intracellular calcium concentration. At the same time it opens ATP‑sensitive potassium channels in vascular smooth muscle, causing peripheral vasodilation and lowering systemic vascular resistance.

The dosing regimen for Levosimendan Bioglan is individualized by the prescribing clinician based on the patient’s clinical status, weight, renal and hepatic function, and response to therapy. No fixed dose can be stated here; the prescriber sets the appropriate infusion rate and duration.

Safety of levosimendan in pregnancy and lactation has not been established. The product is classified as pregnancy category unknown, and it should be used only if the potential benefit justifies the potential risk to the fetus or infant. Consultation with a specialist is recommended.

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

Unlike catecholamine inotropes, levosimendan increases contractility without raising intracellular calcium, which may reduce the risk of calcium‑overload arrhythmias. It also adds vasodilatory effects through potassium‑channel opening, offering afterload reduction that many traditional inotropes lack.

Levosimendan Bioglan must be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking the solution. Do not store at ambient temperature.

Levosimendan Bioglan is given as an intravenous infusion. The solution is typically administered through a controlled infusion pump under continuous hemodynamic monitoring in a hospital setting, allowing the clinician to adjust the rate according to the patient’s response.

The most serious adverse events include severe hypotension, ventricular arrhythmias, and myocardial ischemia. Continuous blood pressure and ECG monitoring are essential during infusion, and any signs of hemodynamic instability should prompt immediate evaluation and possible discontinuation.

Levosimendan is contraindicated in patients with known hypersensitivity to the drug or its excipients, and it should be used with extreme caution in individuals with severe hypotension, uncontrolled arrhythmias, or significant hepatic impairment. Clinical judgment is required for each case.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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