Simendan Injection
Levosimendan
12.5 mg/5 ml
Beacon Pharmaceuticals Ltd.
| Pack size | 1's vital |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 4000.00 AED |
Indications
Simendan Injection is used for:
Acutely decompensated heart failure
Adult Dose
Intravenous
Acutely decompensated heart failure
Adult: In situations where conventional therapy is insufficient and inotropic support is considered appropriate: Loading dose: 6-12 mcg/kg via infusion over 10 minutes.
Maintenance: 0.1 mcg/kg/min via continuous infusion; may decrease to 0.05 mcg/kg/min if significant hypotension or tachycardia occur or may increase to 0.2 mcg/kg/min if the initial dose is tolerated and an increased haemodynamic effect is required.
Dose and duration of treatment are individualised according to the patient’s clinical condition and response.
Patients on concomitant IV vasodilators and/or inotropes: Reduce loading dose to 6 mcg/kg over 10 minutes.
Hepatic Impairment
Severe: Contraindicated.
Child Dose
Renal Dose
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
Administration
Reconstitution
To prepare the 0.025 mg/mL infusion, mix 5 mL of the 2.5 mg/mL inj concentrate with 500 mL of dextrose 5% solution. To prepare the 0.05 mg/mL infusion, mix 10 mL of 2.5 mg/mL inj concentrate with 500 mL of dextrose 5% solution.
Contra Indications
Severe hypotension and tachycardia, history of torsades de pointes, significant mechanical obstructions affecting ventricular filling and/or outflow. Severe hepatic and renal (CrCl <30 mL/min) impairment. Lactation.
Precautions
Patient with low baseline systolic or diastolic blood pressure or those at risk for a hypotensive episode, concurrent ischaemic CV disease and anaemia, tachycardia, atrial fibrillation with rapid ventricular response or potentially life-threatening arrhythmia, ongoing coronary ischaemia, long QTc interval regardless of aetiology.
Patients taking QTc prolonging agents or concomitant IV vasodilators or inotropes. Severe hypovolaemia and hypokalaemia should be corrected prior to the administration. Mild to moderate hepatic and renal impairment. Pregnancy.
Monitor ECG, blood pressure and heart rate during treatment and at least 3 days (5 days in patients with mild to moderate renal and hepatic impairment) after the end of infusion or until the patient is clinically stable; serum K during treatment; urine output. Assess haemodynamic response immediately after loading dose and within 30-60 minutes of any dosage adjustment.
Pregnancy-Lactation
Interactions
Increased risk of hypotension with other IV vasoactive agents. May increase the exposure of drugs that are primarily metabolised by CYP2C8 (e.g. loperamide, pioglitazone, repaglinide, enzalutamide). Concomitant use with isosorbide mononitrate may potentiate orthostatic hypotensive response.
Adverse Effects
Side effects of Levosimendan :
Significant: Hypokalaemia, decreased Hb and haematocrit, ventricular tachycardia, atrial fibrillation, ventricular extrasystoles, hypotension.
Cardiac disorders: Myocardial ischaemia, cardiac failure.
Gastrointestinal disorders: Diarrhoea, constipation, nausea, vomiting.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia.
Mechanism of Action
Levosimendan is a cardiac inotrope and vasodilator with Ca-sensitising properties. It sensitises Ca-dependent troponin C in cardiac tissue, thus increasing contractility. It also opens ATP-sensitive K channels on vascular smooth muscle thereby inducing vasodilation. The combined inotropic and vasodilator activity leads to an increased force of contraction with decreased preload and afterload in the myocardium.
Note
Simendan 12.5 mg/5 ml Injection manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Levosimendan. Simendan is availble in Bangladesh.
Farmaco BD drug index information on Simendan Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.