
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:
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Active ingredient: Levosimendan.
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Supplied as sterile lyophilized powder in vials.
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Reconstituted with a suitable diluent and further diluted before IV infusion.
2. Mechanism of Action:
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Calcium sensitizer: Increases the sensitivity of cardiac muscle fibers to calcium, enhancing contractility without significantly increasing oxygen demand.
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Potassium channel opener (vasodilator): Opens ATP-sensitive potassium channels in vascular smooth muscle, causing vasodilation, reducing preload and afterload.
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Together, these effects improve cardiac output and relieve symptoms of heart failure.
3. Indications:
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Short-term treatment of acute decompensated severe chronic heart failure when conventional therapy is insufficient.
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Used in intensive care or hospital settings under continuous monitoring.
4. Administration:
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Given as an IV infusion, often starting with a loading dose followed by continuous infusion.
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Duration usually ranges from 24 to 48 hours.
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Requires ECG and hemodynamic monitoring during administration.
5. Side Effects:
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Common: headache, hypotension, tachycardia, dizziness, nausea.
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May cause arrhythmias, atrial fibrillation, or hypokalemia.
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Rare but serious: severe hypotension or myocardial ischemia.
6. Contraindications:
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Severe hypotension or tachycardia at baseline.
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Significant renal or hepatic impairment.
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History of torsades de pointes or serious ventricular arrhythmias.
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Obstructive cardiac conditions (e.g., hypertrophic cardiomyopathy with obstruction).
7. Precautions:
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Continuous monitoring of blood pressure, heart rhythm, and electrolytes during infusion.
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Caution in patients with coronary artery disease, electrolyte imbalances, or risk of arrhythmias.
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Not intended for long-term maintenance therapy—used only in acute settings.
8. Storage:
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Store vials in a cool, dry place, protected from light.
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Reconstituted and diluted solutions should be used within the recommended stability period.