Limitations on use of Ventolin® (salbutamol sulphate) for inhibition of premature labour

GlaxoSmithKline would like to inform healthcare professionals of important restrictions regarding the use of oral and parenteral Ventolin^® in the treatment of premature labour. Obstetric use of short-acting beta-agonists (SABA), including salbutamol sulphate, is associated with serious, sometimes fatal, adverse cardiovascular events in both the mother and the foetus or new-born. Oral salbutamol sulphate should not be used in the treatment of premature labour and the use of parenteral salbutamol sulphate should be limited to inhibition of premature labour between the 22^nd and 37^th weeks of gestation for a maximum of 48 hours and administered with close monitoring of both mother and foetus. In addition, parenteral salbutamol sulphate should not be used in women with a history of heart disease or in any conditions where prolongation of the pregnancy is hazardous to the mother and foetus. The local package insert for oral Ventolin^® has been updated with the removal of the obstetric indication while the local package insert for parenteral Ventolin^® is in the process of been strengthened to include additional recommendations for screening and monitoring during management of premature labour. The above revisions to the prescribing information for both oral and parenteral administration of Ventolin^® do not alter the prescribing information regarding the  use of Ventolin^® for respiratory indications, including pregnant women. Please refer to HSA website for the latest approved package inserts for oral and parenteral Ventolin^®. Published: 1 Jul 2014

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