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)

Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. [2009.06]
Peri-operative prophylactic anti-emetics are commonly used parenterally... In conclusion, orally disintegrating ondansetron was as efficacious as intravenous ondansetron in the peri-operative phase and may be a viable option for prophylaxis of emesis in day care surgery.

A randomized, double-blind, multicenter trial comparing transdermal scopolamine plus ondansetron to ondansetron alone for the prevention of postoperative nausea and vomiting in the outpatient setting. [2009.05]
BACKGROUND: Postoperative nausea and vomiting (PONV) are common complications after ambulatory surgery. We sought to determine whether the use of transdermal scopolamine (TDS) in combination with IV ondansetron (OND) is more effective than one alone for reducing PONV in outpatient settings... CONCLUSIONS: TDS + OND reduces PONV compared with OND alone. This is achieved with a reduction in adverse events.

Haloperidol plus ondansetron prevents postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. [2009.03]
BACKGROUND: A combination of antiemetic drugs could be an effective method to prevent severe postoperative nausea and vomiting (PONV). Therefore, we examined the prophylactic effect of haloperidol plus ondansetron on PONV... CONCLUSION: We conclude that the combination of prophylactic haloperidol (2 mg) plus ondansetron (4 mg) provides a higher complete response rate and greater patient satisfaction after laparoscopic cholecystectomy than either drug used alone.

Postoperative intravenous patient-controlled analgesia in thyroid surgery: comparison of fentanyl and ondansetron regimens with and without the nonsteriodal anti-inflammatory drug ketorolac. [2008.12]
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs), through synergistic action with opioids, can reduce postoperative nausea and vomiting via intravenous patient-controlled analgesia (PCA). We compared the efficacy of three PCA regimens... CONCLUSIONS: The NSAID ketorolac when combined with lower doses of the opioid fentanyl and the same dose of ondansetron is associated with the same analgesic efficacy but less nausea and vomiting after thyroid surgery. A higher ratio of NSAID to opioid, when used as reported here, is associated with less postoperative dizziness.

Oral ondansetron is highly active as rescue antiemetic treatment for moderately emetogenic chemotherapy: results of a randomized phase II study. [2008.12]
AIMS: In the present phase II randomized study, two different schedules of ondansetron were investigated as rescue antiemetic treatment for delayed emesis related to moderately emetogenic chemotherapy (MEC)... CONCLUSIONS: Due to its high efficacy and excellent tolerability, oral ondansetron is an important option in the management of MEC-related delayed emesis refractory to standard antiemetic prophylaxis.

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

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