Levosimendan Lyophilized Injection

Product/Composition Levosimendan Lyophilized Injection
Strength 12.5mg
Form Lyophilized Injection
Production Capacity 1 Million Lyophilized Injection/Month
Therapeutic use Cardiovascular
Package Insert/Leaflet Available upon request

Levosimendan Lyophilized Injection is a cardiovascular drug used in the management of acute decompensated heart failure. It is prepared as a lyophilized (freeze-dried) powder that requires reconstitution before administration, usually as an intravenous infusion under hospital supervision.

Here are the key details:

1. Composition and Form:

  • Active ingredient: Levosimendan.

  • Supplied as sterile lyophilized powder in vials.

  • Reconstituted with a suitable diluent and further diluted before IV infusion.

2. Mechanism of Action:

  • Calcium sensitizer: Increases the sensitivity of cardiac muscle fibers to calcium, enhancing contractility without significantly increasing oxygen demand.

  • Potassium channel opener (vasodilator): Opens ATP-sensitive potassium channels in vascular smooth muscle, causing vasodilation, reducing preload and afterload.

  • Together, these effects improve cardiac output and relieve symptoms of heart failure.

3. Indications:

  • Short-term treatment of acute decompensated severe chronic heart failure when conventional therapy is insufficient.

  • Used in intensive care or hospital settings under continuous monitoring.

4. Administration:

  • Given as an IV infusion, often starting with a loading dose followed by continuous infusion.

  • Duration usually ranges from 24 to 48 hours.

  • Requires ECG and hemodynamic monitoring during administration.

5. Side Effects:

  • Common: headache, hypotension, tachycardia, dizziness, nausea.

  • May cause arrhythmias, atrial fibrillation, or hypokalemia.

  • Rare but serious: severe hypotension or myocardial ischemia.

6. Contraindications:

  • Severe hypotension or tachycardia at baseline.

  • Significant renal or hepatic impairment.

  • History of torsades de pointes or serious ventricular arrhythmias.

  • Obstructive cardiac conditions (e.g., hypertrophic cardiomyopathy with obstruction).

7. Precautions:

  • Continuous monitoring of blood pressure, heart rhythm, and electrolytes during infusion.

  • Caution in patients with coronary artery disease, electrolyte imbalances, or risk of arrhythmias.

  • Not intended for long-term maintenance therapy—used only in acute settings.

8. Storage:

  • Store vials in a cool, dry place, protected from light.

  • Reconstituted and diluted solutions should be used within the recommended stability period.