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)

The effect of ondansetron and meperedin on preventing shivering after off-pump coronary artery bypass graft. [2012]
One of the most common complications of operation and anesthesia is shivering. The purpose of this study was to compare the effectiveness of Ondanseton and Meperedine in preventing shivering after off-pump coronary artery bypass graft (OPCAB)... According to the findings, it was demonstrated that ondansetron is more effective in preventing shivering after Off-pump CABG than meperedine.

Dexamethasone versus ondansetron in combination with dexamethasone for the prophylaxis of postoperative vomiting in pediatric outpatients: a double-blind, randomized, placebo-controlled clinical trial. [2012]
incidence of which ranges from 8.9% to 42%... CONCLUSIONS: The prophylactic use of antiemetic drugs failed to reduce the

Anti-emetic effect of ondansetron and palonosetron in thyroidectomy: a prospective, randomized, double-blind study. [2012]
high-risk patients receiving i.v. PCA after thyroidectomy... CONCLUSIONS: Palonosetron is more effective than ondansetron for high-risk

Aprepitant plus ondansetron compared with ondansetron alone in reducing postoperative nausea and vomiting in ambulatory patients undergoing plastic surgery. [2012]
outpatient plastic surgery... CONCLUSION: In patients undergoing plastic surgery, the addition of aprepitant to

Aprepitant Plus Ondansetron Compared to Ondansetron Alone in Reducing Postoperative Nausea and Vomiting in Ambulatory Patients Undergoing Plastic Surgery. [2011.10.07]
BACKGROUND:: Postoperative nausea and vomiting (PONV) is a major challenge in the peri-operative setting. The incidence can be as high as 80%, and the majority of PONV symptoms among out-patients occur after discharge. This study evaluated the efficacy of an NK1 receptor antagonist (aprepitant) in reducing PONV for up to forty-eight hours in patients undergoing outpatient plastic surgery... CONCLUSIONS:: In patients undergoing plastic surgery, the addition of aprepitant to ondansetron significantly decreases postoperative vomiting rates and nausea severity for up to 48 hours postoperatively. LEVEL OF EVIDENCE:: Level 2 single-centered prospective randomized controlled therapeutic trial.

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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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Reports of Suspected Zofran (Ondansetron) Side Effects

Vomiting (37),  Nausea (31),  Malaise (29),  Abdominal Pain (27),  Headache (26),  Fatigue (22),  Pruritus (17),  Maternal Exposure During Pregnancy (17),  Cognitive Disorder (17),  Drug Ineffective (15), more >>

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 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

Zofran review by 46 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		nausea (after surgery)
Dosage & duration:		2mg IV push taken 1x for the period of 1 hour
Other conditions:		none
Other drugs taken:		Dilaudid
		Reported Results
Benefits:		Was prescribed in hospital to relieve nausea I was suffering, post foraminotomy.
Side effects:		Anaphylactic reaction. Extreme shaking of extremities. Loss of consciousness. Treated by hospital ER staff. Prior known allergic reaction to Compazine, hospital pharmacy said they were unrelated class of drugs and should not have caused allergic reaction. Physician suggested I take no anti-nausea drugs from now on.
Comments:		IV Steroids.