Simdax

Simdax

levosimendan

Manufacturer:

Orion Pharma

Distributor:

Apex
Concise Prescribing Info
Contents
Levosimendan
Indications/Uses
Short-term treatment of acutely decompensated severe chronic heart failure (ADHF) wherein conventional therapy is insufficient & in cases where inotropic support is appropriate.
Dosage/Direction for Use
IV infusion Individualized dosage. Initially 6-12 mcg/kg loading dose infused over 10 min followed by continuous infusion of 0.1 mcg/kg/min. May be decreased to 0.05 mcg/kg/min or increased to 0.2 mcg/kg/min.
Contraindications
Hypersensitivity. Severe hypotension & tachycardia. Significant mechanical obstructions affecting ventricular filling, outflow or both. History of Torsade de pointes. Severe renal (CrCl <30 mL/min) & hepatic impairment.
Special Precautions
Reduce or discontinue use if excessive BP or heart rate changes occur. Low baseline systolic or diastolic BP or at risk for hypotensive episode; ischaemic CV disease & concurrent anaemia; tachycardia, atrial fibrillation w/ rapid ventricular response or potentially life-threatening arrhythmias; cardiogenic shock, restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade, right ventricular infarction; heart failure after surgery, severe heart failure in patients awaiting heart transplantation. Correct severe hypovolaemia & low serum K conc prior to infusion. Perform non-invasive monitoring for haemodynamic effects for at least 4-5 days after end of infusion. Closely monitor ECG in patients w/ ongoing coronary ischaemia, long QTc interval or concomitant use w/ drugs prolonging QTc interval. Concomitant use w/ vasoactive agents including inotropic agents (except digoxin). Mild to moderate renal & hepatic impairment. Pregnancy. Not to be used during lactation. Not to be used in childn & adolescents <18 yr.
Adverse Reactions
Headache; ventricular tachycardia; hypotension. Hypokalaemia; insomnia; dizziness; atrial fibrillation, tachycardia, ventricular extrasystoles, cardiac failure, myocardial ischaemia, extrasystoles; nausea, constipation, diarrhoea, vomiting; decreased Hb.
Drug Interactions
Increased risk of hypotension w/ other IV vasoactive medicinal products. Significant potentiation of orthostatic hypotensive response w/ isosorbide mononitrate.
MIMS Class
Other Cardiovascular Drugs
ATC Classification
C01CX08 - levosimendan ; Belongs to the class of other cardiac stimulants excluding glycosides. Used in the treatment of hypotension.
Presentation/Packing
Form
Simdax infusion conc 2.5 mg/mL
Packing/Price
10 mL x 10 × 1's;10 mL x 1's;10 mL x 4 × 1's;5 mL x 10 × 1's;5 mL x 1's;5 mL x 4 × 1's
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