Zofran (Ondansetron) - Summary

ZOFRAN SUMMARY

The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, 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 highly emetogenic cancer chemotherapy, including cisplatin >/=50 mg/m².
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
4. 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 Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.

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NEWS HIGHLIGHTS

Published Studies Related to Zofran (Ondansetron)

Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. [2009.10.15]
BACKGROUND:: This randomized, double-blind, dose-ranging, placebo-controlled, phase 2 trial evaluated the neurokinin-1 receptor antagonist casopitant mesylate in combination with ondansetron/dexamethasone (ond/dex) for the prevention of chemotherapy-induced nausea and vomiting (CINV) related to moderately emetogenic chemotherapy (MEC)... CONCLUSIONS:: Casopitant plus ond/dex was more effective than ond/dex alone for the prevention of CINV. Cancer 2009. (c) 2009 American Cancer Society.

Clinical trial: Oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children - a double-blind randomised study. [2009.09.16]
Summary Background: Vomiting due to gastroenteritis frequently occurs in children. It is still debatable whether vomiting should be treated with antiemetic drugs...

A randomized, double-blinded comparison of ondansetron, granisetron, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. [2009.07]
Postoperative nausea and vomiting (PONV) are frequent and distressing complications after neurosurgical procedures... However, neither drugs prevented nausea effectively.

Transdermal scopolamine patch in addition to ondansetron for postoperative nausea and vomiting prophylaxis in patients undergoing ambulatory cosmetic surgery. [2009.06]
STUDY OBJECTIVE: To determine the efficacy of transdermal scopolamine in addition to ondansetron in decreasing the incidence of postoperative nausea and vomiting (PONV)... CONCLUSIONS: Transdermal scopolamine in addition to ondansetron benefits patients at high risk for PONV undergoing outpatient plastic surgery for up to 20 hours after surgery.

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.

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Clinical Trials Related to Zofran (Ondansetron)

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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PATIENT REVIEWS / RATINGS / COMMENTS

Zofran review by 21 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		nausea
Dosage & duration:		4mg taken once daily for the period of 6 months
Other conditions:		pregnancy
Other drugs taken:		prenatal vitamins
		Reported Results
Benefits:		cured the hyperemesis I was suffering completely with no noticeable side effects.
Side effects:		Because it specifically treats the stomach there were no side effects to any other part of my body.
Comments:		I was suffering hyperemesis during pregnancy and was not able to take other anti nausea pills due to side effects and potential risks to the fetus. So this very safe, gentle pill was given to me and it worked perfectly.

Zofran review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		nausea/vomiting
Dosage & duration:		8 mg taken twice a day for the period of three months
Other conditions:		undiagnoses gastrointestinal difficulties
Other drugs taken:		aciphex
		Reported Results
Benefits:		Completely controlled nausea and vomiting.
Side effects:		Some sleepiness
Comments:		I was dealing with unrelenting nausea and vomiting for about five months. A combination of other drugs was tried, and they had a limited ability to control the nausea. I had lost a lot of weight, and was at the point where the weight loss had left me pale and weak. When Zofran was added to the list of drugs I was given, I had immediate relief and was able to stop taking several of the other drugs. I now take Zofran in the morning and evening and have stopped an unwanted weight loss and can enjoy eating again. I recently had a biopsy where I had to have nothing in my stomach for twelve hours. The prescribed pain killers after the procedure immediately brought back the vomiting, and my friend reminded the nurse that I usually used Zofran for that. Within ten minutes after giving me a dose the nausea was gone and I was able to get much needed rest.

Zofran review by 34 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		nausea
Dosage & duration:		4mg taken 2 times/day for the period of 4 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		no nausea, less vomiting. able to get through work and school feeling better
Side effects:		mild dizziness, sometimes I would get a headache
Comments:		I was prescribes 4 mg zofran to take 4 times per day for relief of nausea and vomiting which was most likely due to vertigo. I had a decrease in the nausea symptoms after the first dose, and had total relief after about 3 doses. i did experience a mile headache, which I believe is common for this drug