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Dextrose, Ondansetron Hydrochloride Solution for injection

It is used to treat nausea and vomiting caused by chemotherapy

Generic Name: ondansetron  |  Brand Name: Zuplenz

Brand Names: Zofran ODT, Zofran, Zuplenz, Ondansetron Hydrochloride

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 09/15/2011] ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.

BACKGROUND: Ondansetron (Zofran) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which ondansetron may cause QT interval prolongation.

RECOMMENDATION: The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

ONDANSETRON (on DAN se tron) is used to treat nausea and vomiting caused by chemotherapy. It is also used to prevent or treat nausea and vomiting after surgery.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • history of irregular heartbeat
  • liver disease
  • low levels of magnesium or potassium in the blood
  • an unusual or allergic reaction to ondansetron, granisetron, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

-apomorphine
This medicine may also interact with the following medications:

-carbamazepine
-phenytoin
-rifampicin
-tramadol

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • dizziness
  • fast or irregular heartbeat
  • feeling faint or lightheaded, falls
  • fever and chills
  • swelling of the hands and feet
  • tightness in the chest

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation or diarrhea
  • headache

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: September 21, 2011
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