Zofran® (Ondansetron): Dose-dependent QT interval prolongation – updated information on posology for intravenous (IV) use in the prevention of Chemotherapy-Induced Nausea And Vomiting (CINV)

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Date: 14 April 2014

Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of dose-dependent QT interval prolongation – updated information on posology for intravenous (IV) use involving Zofran®.Ondansetron has been shown to cause a dose-dependent prolongation of the electrocardio-graphic- corrected QT interval (QTc), which can lead to Torsade de Pointes. Therefore new dose restrictions, dosing intervals, and dilution protocols are in place for use of intravenous ondansetron. Healthcare professionals are reminded that caution must be used if administering ondansetron to patients with risk factors for QT interval prolongation or cardiac arrhythmias. Hypokalaemia and hypomagnesaemia should be corrected prior to ondansetron administration. GlaxoSmithKlinePharmaceuticals (M) Sdn. Bhd. is updating the package insert for Zofran® to incorporate this new safety information. Please refer to the DHPC for further information.

National Pharmaceutical Regulatory Agency (NPRA)
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