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Zofran Injection (Ondansetron Hydrochloride Injection) - Summary

 
 



SUMMARY

The active ingredient in ZOFRAN Injection and ZOFRAN Injection Premixed is ondansetron hydrochloride (HCl), the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type.

  1. Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Efficacy of the 32-mg single dose beyond 24 hours in these patients has not been established.
  2. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ZOFRAN Injection and experience nausea and/or vomiting postoperatively, ZOFRAN Injection may be given to prevent further episodes (see CLINICAL TRIALS).


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NEWS HIGHLIGHTS

Published Studies Related to Zofran Injection (Ondansetron Injection)

Ondansetron reducing pain on injection of etomidate: a controlled randomized study. [2014]
of etomidate... CONCLUSION: This study illustrates that pre-treatment with intravenous

Comparison of ondansetron and metoclopramide antiemetic prophylaxis in maxillofacial surgery patients. [2011.03]
PURPOSE: The purpose of this study was to compare the efficacy of ondansetron and metoclopramide, administered for the prophylaxis of vomiting in patients undergoing oral and maxillofacial surgery under general anesthesia... CONCLUSION: In this study, ondansetron (0.1 mg/kg) was twice as effective in preventing postoperative vomiting compared with metoclopramide. Copyright (c) 2011 Mosby, Inc. All rights reserved.

Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. [2011.02]
HYPOTHESIS: Postoperative nausea and vomiting (PONV) are associated with a variety of complications. Neurokinin subtype 1 receptor antagonists have antiemetic activity in the postoperative setting, and the neurokinin subtype 1 receptor antagonist casopitant mesylate (GW679769) was well tolerated and effective at reducing the incidence of PONV in phase 1 and phase 2 trials... CONCLUSIONS: The results of this pivotal phase 3 study demonstrate that the combination of casopitant and ondansetron was superior to ondansetron only in patients at high risk for PONV. Trial Registration clinicaltrials.gov Identifier: NCT00326248.

Effect of intravenous ondansetron on sensory and motor block after spinal anaesthesia with hyperbaric bupivacaine. [2011.01]
Ondansetron is a potent antiemetic and a competitive antagonist at serotonin receptors, which are also involved in modulation of pain. This study was designed to assess the effect of systemic ondansetron on sensory and motor block after subarachnoid anaesthesia with hyperbaric bupivacaine... We concluded that intravenous ondansetron does not affect the intensity or duration of sensory and motor block after spinal anaesthesia with hyperbaric bupivacaine.

Prophylactic control of post-operative nausea and vomiting using ondansetron and ramosetron after cardiac surgery. [2010.09]
BACKGROUND: The aim of this study was to evaluate the efficacy of ondansetron and ramosetron in the reduction of post-operative nausea and vomiting (PONV) associated with patient-controlled analgesia (PCA) after cardiac surgery... CONCLUSION: The addition of either ondansetron or ramosetron to PCA can reduce the incidence of PONV during 48 h after cardiac surgery.

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Clinical Trials Related to Zofran Injection (Ondansetron Injection)

To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects [Completed]
Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will be used as a positive control and will be given orally. The cardiac repolarization will be measured by taking consecutive ECGs on a recording device known as a Holter monitor and measuring the QT interval at specified times. In addition, blood samples will also be taken at specified times and will be used to measure the amount of study medication in the body.

Ondansetron and the QT Interval In Adult Emergency Department Patients [Completed]
The purpose of this study is to assess the use of the medication ondansetron (zofran) in the emergency department. There are studies of the ability of ondansetron to cause a prolongation in the QT interval (a certain measurement on an EKG) in anesthesia and cancer patients, but not on emergency department patients. This is an observational study where patients that are going to receive the anti-nausea medicine ondansetron in the emergency department will have an EKG performed every 2 minutes for 20 minutes to determine if the QT interval prolongs and returns to normal in that time period. Any serious outcomes will be reported. There is expected to be no adverse outcomes from this routinely used medication.

How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women [Completed]
This is called "Aim 1" of the investigators' NIH grant. Ondansetron (Zofran) is a safe and effective drug used in pregnant women to prevent nausea but the investigators do not know what effect pregnancy may have on the metabolism of Zofran in pregnant women or their babies. Therefore the investigators will enroll approximately 40 pregnant women and their babies and draw blood samples from the mother, the baby and the cord, to determine how much Zofran is in each sample of blood (called the pharmacokinetics or PK of Zofran). The pregnant women will receive Zofran, as a standard-of-care drug, for their scheduled Cesarean Section. The investigators will also enroll about 20 non-pregnant women undergoing surgery who will receive Zofran as standard-of-care during surgery. In both the pregnant & the non-pregnant women, the investigators will draw blood samples at the same time points based on number of minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the investigators move into Aim 2 of the study, which will be done in pregnant, narcotic-addicted mothers and their babies who are born addicted to narcotics. Aim 2 will be listed separately as it will be an interventional study.

Cross-over Bioequivalence Fasting Study to Compare Ondansetron Oral Soluble Film (OSF)With Zofran Orally Disintegrating Tablets(ODT) [Completed]
The purpose of this study was to assess the single dose bioequivalence of Ondansetron OSF 8mg (Manufactured by MonoSol Rx, USA) with Zofran ODT® (Containing Ondansetron 8 mg) (Manufactured by Cardinal Heasth Blagrove, Swindon, Wiltshire, UK, SN58RU for Glaxo SmithKline, Research Triangle Park, NC 27709, Made in England) in healthy, male and female adult, human study participants under fasting conditions. • To monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fasting conditions.

Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions [Completed]

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Page last updated: 2015-08-10

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