Simdax

Simdax

levosimendan

Manufacturer:

Orion

Distributor:

Zuellig Pharma

Marketer:

Orion Pharma Thai
Concise Prescribing Info
Contents
Levosimendan
Indications/Uses
Short-term treatment of acutely decompensated severe chronic heart failure (ADHF) wherein conventional therapy is not sufficient & 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 a continuous infusion of 0.1 mcg/kg/min. Lower loading dose of 6 mcg/kg is recommended in patients on concomitant IV vasodilators or inotropes or both at start of infusion. Rate of infusion may be decreased to 0.05 mcg/kg/min or discontinued if response is deemed excessive; may be increased to 0.2 mcg/kg/min if initial dose is tolerated. Duration of infusion: 24 hr.
Contraindications
Hypersensitivity. Severe hypotension & tachycardia. Significant mechanical obstructions affecting ventricular filling or outflow or both. Severe renal impairment (CrCl <30 mL/min) & severe hepatic impairment. History of Torsades de Pointes.
Special Precautions
Patient's w/ low baseline systolic or diastolic BP or those at risk for a hypotensive episode. Correct severe hypovolaemia prior to infusion. Reduce or discontinue if excessive changes in BP or heart rate are observed. Non-invasive monitoring for haemodynamic effects for at least 4-5 days after the end of infusion is recommended. Mild to moderate renal & hepatic impairment. Correct low serum K conc prior to treatment & monitor during therapy. Ischaemic CV disease & concurrent anaemia. Concomitant use w/ vasoactive agents, including inotropic agents (except digoxin). Tachycardia atrial fibrillation w/ rapid ventricular response or potentially life-threatening arrhythmias. Closely monitor ECG in patients w/ on-going coronary ischaemia, long QTc interval regardless of aetiology & concomitant use w/ drugs that prolong QTc interval. Childn & adolescent <18 yr. Pregnancy & lactation.
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/ IV vasoactive drugs. 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
5 mL x 1's
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