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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)

Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. [2014]
hyperemesis gravidarum... CONCLUSION: Ondansetron and metoclopramide demonstrated similar antiemetic and

Effect of oral ondansetron on decreasing the vomiting associated with acute gastroenteritis in Iranian children. [2013]
in decreasing the vomiting due to acute gastroenteritis in children... CONCLUSION: Although administrayion of oral ondansetron in gastroenteritis could

Ondansetrone or metoclopromide? Which is more effective in severe nausea and vomiting of pregnancy? A randomized trial double-blind study. [2013]
of OND versus metoclopramide (MET) in the treatment of HG... CONCLUSION: OND has a more favorable effect in controlling severe vomiting.

Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study. [2013]
The aim of this study was to assess the effect of ondansetron on symptoms of patients with subjective tinnitus accompanied by sensorineural hearing loss or normal hearing. Sixty patients with a chief complaint of tinnitus (with duration of more than 3 months) were equally randomized to ondansetron or placebo for 4 weeks...

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.

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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 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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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

Based on a total of 10 ratings/reviews, Zofran has an overall score of 6.30. The effectiveness score is 7.40 and the side effect score is 6.60. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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.

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Page last updated: 2014-12-01

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