A single dose of ondansetron 0.1 mg/kg was administered within five minutes following induction of anaesthesia. Based on this analysis, systemic exposure (AUC) of ondansetron following oral or IV dosing in children and adolescents was comparable to adults, with the exception of infants aged 1 to 4 months. In such patients a total daily dose of 8 mg should not be exceeded and therefore parenteral or oral administration is recommended. Terminal half life is about 3 hours. These reactions were frequently observed in patients under chemotherapy with cisplatin.Hypersensitivity reactions around the injection site (e.g. No detrimental effects on such activities are predicted from the pharmacology of ondansetron.Adverse events are listed below by system organ class and frequency. It is considered that adequate stability would also be conferred by the use of polyethylene infusion bags or Type 1 glass bottles.Dilutions of Ondansetron in sodium chloride 0.9%w/v or in glucose 5%w/v have been demonstrated to be stable in polypropylene syringes. epileptic spasms) have been observed although no known pharmacological mechanism can account for ondansetron causing these effects.Dizziness during rapid intravenous administration. Ondansetron 2mg/ml Solution for Injection should not be mixed with other medicinal products except those mentioned in section 6.6.Ondansetron injection should not be administered in the same syringe or infusion as any other medication.After first opening the medicinal product should be used immediately.Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8°C with the solutions given in section 6.6.From a microbiological point of view, the product should be used immediately. • 71% of patients when ondansetron was administered as syrup at a dose of 8 mg together with 2-4 mg dexamethasone orally on the days of chemotherapy.Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 2 days. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.Hypokalaemia and hypomagnesaemia should be corrected prior to ondansetron administration.There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). QT Prolongation . If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.This medicinal product does not require any special storage temperature. In this study, there were no QTcF measurements greater than 480 msec and no QTcF prolongation was greater than 60 msec. 1. No significant changes were seen in the measured electrocardiographic PR or QRS intervals.The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 patients aged 1 to 18 years (S3AB3006). No alteration of daily dosage or frequency of dosing are required.For intravenous injection, intravenous infusion after dilution or intramuscular administration.For instructions on dilution of the product before administration, see section 6.6.Hypersensitivity to the active substance or to other selective 5HT3 receptor antagonists (e.g. Important information Each glass ampoule of 2ml contains 4mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. Some cases of transient blindness were reported as cortical in origin.Chest pain with or without ST segment depression, cardiac arrhythmias and bradycardia. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. Chest pain and cardiac arrhythmias may be fatal in individual cases.Transitory changes in the electrocardiogram, QTc prolongation (including Torsades de Pointes)Ondansetron is known to increase the large bowel transit time and may cause constipation in some patients.Asymptomatic increases in liver function tests were observed.
There is no specific antidote for ondansetron; therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.A double-blind randomised placebo-controlled trial (S3AB4003) in 438 patients aged 1 to17 years demonstrated complete control of emesis on worst day of chemotherapy in: Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of young adults.
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