Vaxcel Granisetron Special Precautions

As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored closely following its administration. As for other 5-HT₃ antagonists, cases of Electrocardiogram (ECG) modifications including QT interval prolongation have been reported with granisetron. These ECG changes with granisetron were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia. However, this might lead to clinical consequences in patients with pre-existing arrhythmias or cardiac conduction disorders. Therefore caution should be exercised in patients with cardiac co-morbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities. Cross-sensitivity between 5-HT₃ antagonists (e.g. dolasetron, ondansetron) has been reported. As this preparation contains Benzyl Alcohol, its use should be avoided in children under two years of age. Not to be used in neonates.
Effects on ability to drive and use machines: No clinically relevant effects on resting EEG or on the performance of psychometric tests were observed in healthy subjects after i.v. granisetron at any dose tested (up to 200 μg/kg). There are no data on the effect of granisetron on the ability to drive or use machinery.