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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).


See all Zofran Injection indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zofran Injection (Ondansetron Injection)

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.

Acupressure using ondansetron versus metoclopramide on reduction of postoperative nausea and vomiting after strabismus surgery. [2010.07]
OBJECTIVE: To compare the clinical efficacy of acupressure with treatment induced by ondansetron and metoclopramide on reduction of the severity of postoperative nausea and vomiting (PONV) after strabismus surgery... CONCLUSION: Acupressure at the P6 point causes a significant reduction in the incidence and severity of PONV 24 hours after strabismus surgery as well as metoclopramide (0.2 mg/kg) and ondansetron (0.15 mg/kg) intravenous for patients aged 10 or older. (Irct ID: IRCT138807152556N1).

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Clinical Trials Related to Zofran Injection (Ondansetron Injection)

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

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions [Completed]

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

Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions [Completed]

Fasting Study of Ondansetron Tablets 24 mg and ZofranŽ Tablets 24 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's ZofranŽ 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.

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Page last updated: 2011-12-09

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