At the 4-mg dosage, 59% of patients receiving ondansetron versus 45% receiving placebo in the first trial (Three double-blind, placebo-controlled trials have been performed (one US, two foreign) in 1,049 male and female patients (aged 2 to 12 years) undergoing general anesthesia with nitrous oxide. A scatter lying predominantly between the line of equality (dotted) and the y-axis indicates consistent efficacy of ondansetron compared with control and relative homogeneity of the data set. Concomitant use of apomorphine and Ondansetron Injection may cause a significant drop in blood pressure and loss of consciousness.•Advise patients of the possibility of serotonin syndrome with concomitant use of Ondansetron Injection and another serotonergic agent such as medications to treat depression and migraines. In multiple-dose trials, only the first dose accounted for early outcomes (A). Clin Pharmacol Ther 1993; 54:53-7.Pritchard JF, Bryson JC, Kernodle AE, Benedetti TL, Powell JR: Age and gender effects on ondansetron pharmacokinetics: Evaluation of healthy aged volunteers.
Minerva Anestesiol 1994; 60(Suppl 1/1-2):79-80.D'Ari M, Caccia A, Lo Sapio D, Verde A, Badolato A, Chiefari M: Ondansetron vs metoclopramide e placebo nella prevenzione della nausea e del vomito postoperatorio. sea and/or vomiting at the time ondansetron was commenced and 48 hr after the first dose. In an oral pre- and post-natal development study pregnant rats received doses of ondansetron up to 15 mg/kg/day from Day 17 of pregnancy to litter Day 21. Dr. Tramer holds a UK Overseas Research Student Award. Adverse Reactions Reported in ≥2% (and with Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes[see Clinical Studies (14.1), Dosage and Administration (2)]Table 4. Eleven trials were done in children. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China 34120001211B April 2017 Ondansetron was significantly more effective than placebo in preventing nausea and vomiting. PH A R M A C E U T ICAL FORM Solution for Injection. anaesthesia with propofol. Search for other works by this author on: [Because trials were inconsistent in reporting intention-to-treat data, we used efficacy data. Ondansetron has no effect on plasma prolactin concentrations. These highlights do not include all the information needed to use ONDANSETRON INJECTION safely and effectively. Ondansetron Injection was administered intravenously over 15 minutes in three doses of 0.15 mg/kg. With the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated F1 generation.It is not known whether ondansetron is present in human milk. (Ondansetron Injection is approved for patients aged 6 months and older.Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting.
Search for other works by this author on: Thus, prevention of vomiting in these pediatric patients was comparable to the prevention of vomiting in patients aged 4 years and older.Adult surgical patients who received ondansetron immediately before the induction of general balanced anesthesia (barbiturate: thiopental, methohexital, or thiamylal; opioid: alfentanil or fentanyl; nitrous oxide; neuromuscular blockade: succinylcholine/curare and/or vecuronium or atracurium; and supplemental isoflurane) were evaluated in two double-blind US trials involving 554 patients. Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see Adverse Reactions (6.2)]. The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron.Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope.
However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs Although there are no data on pharmacokinetic drug interactions between ondansetron and tramadol, data from two small trials indicate that concomitant use of ondansetron may result in reduced analgesic activity of tramadol.
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