1 vial

$1400.00

  • Patients undergoing cardiac surgery who have impaired systolic function & evidence of acute decompensated heart failure despite maximal medical therapy.
Note:Administration in ICU is only possible after discussion with the ICU Specialist.
IV
Levosimendan comes in a vial containing 12.5mg in 5ml (2.5mg/ml).
Refrigerate.
Compatible with the following IV fluids:
D5W
Levosimendan can be safely co-administered with frusemide (10mg/ml), digoxin (0.25mg/ml) or glyceryl trinitrate (0.1mg/ml)

Levosimendan is prepared by diluting one 5ml vial of 2.5mg/ml solution in 500ml of 5% dextrose to make a 0.025mg/ml solution. Administer by infusion only.
Do NOT administer a loading dose as this increases the risk of adverse events.
Begin the infusion at a rate of 0.05mcg/kg/min (see Dosage table below).
If this is tolerated for one hour, increase the infusion rate to 0.1mcg/kg/min.
If this is tolerated for the subsequent hour, increase the infusion rate to 0.2mcg/kg/min. This is the maximum dose.
Cease the levosimendan infusion after 24 hours.
The blood pressure should be checked both 15 minutes & 1 hour after either commencing the infusion or adjusting the infusion rate, if not already continuously monitored.

ADULT DOSE

The following infusion rates apply only to the 0.025mg/ml preparation of Levosimendan prepared as directed above.
Cefuroxime table

PAEDIATRIC DOSE

Levosimendan should not be administered to children or adolescents under 18 years of age.

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY

No dose adjustment is required for mild to moderate renal failure but the resultant increase in active metabolite concentration may cause a more pronounced and prolonged haemodynamic effect. Levosimendan is contraindicated in severe renal impairment (defined below). It is not removed by haemodialysis.

Levosimendan is a calcium sensitiser which increases cardiac contractility by enhancing the sensitivity of the heart to calcium. Haemodynamic effects persists for at least 24 hours and may be seen up to 9 days after discontinuation of a 24-hour infusion due to the presence of active metabolites that reach maximum plasma concentrations about 48 hours after the infusion has stopped.
CONTRAINDICATIONS:
  • Hypersensitivity to Levosimendan
  • Severe hepatic impairment
  • Severe renal impairment (creatinine clearance <30ml/min)
  • Severe hypovolaemia (this potentiates the hypotensive effects)

WARNINGS
Cardiovascular adverse effects
The most frequent adverse effects are hypotension, QT prolongation and arrhythmias (ectopy, atrial fibrillation and ventricular tachycardia). If hypotension or arrhythmias occur, the infusion should be stopped pending medical review after which the infusion may be restarted at a lower dose.
Patients receiving a Levosimendan infusion should undergo continuous ECG monitoring with blood pressure monitored as described in ‘Administration’ guidelines above.

Electrolytes
Levosimendan may cause a decrease in serum potassium concentration; hypokalaemia should be corrected prior to administration.

PRECAUTIONS
General
Co-administration with other drugs that prolong the QT interval should be undertaken with caution. Continuous ECG monitoring is required for these patients as well as for those already showing arrhythmias prior to Levosimendan administration.

Laboratory Tests

No tests are required in addition to routine ICU blood tests; vigilance for & correction of hypokalaemia is recommended.

Drug/Laboratory Test Interactions
None known


Pregnancy
Levosimendan has been given to only a limited number of pregnant women and women of childbearing age without an increase in the frequency of malformation on the human fetus having been observed. Animal studies have shown evidence of an increased occurrence of fetal damage of uncertain significance in humans.

Nursing Mothers
Levosimendan is excreted into maternal milk in animal studies. No human data is available.

Paediatric Use
Levosimendan should not be administered to children or adolescents under 18 years of age.

Nervous system:
Headaches, dizziness, insomnia

Cardiovascular:

Arrhythmias (VT, AF, ventricular extrasystoles, tachycardia), hypotension

Digestive:
Diarrhoea, vomiting, constipation, nausea
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