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Basic Drug Info
Drug Name:Ondansetron
Manufacturer:WEST-WARD PHARMACEUTICAL Corp.
Other Info:

Stability: Ondansetron injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following I.V.

fluids: 0.9% sodium chloride injection, 5 % dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, and 3% sodium chloride injection.Although ondansetron injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.

After dilution, do not use beyond 24 hours.Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright.

Potency and safety are not affected.

If a precipitate is observed, resolubilize by shaking the vial vigorously.



Clinical Trials:


Indications and Usage

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.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, ondansetron injection, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.

For patients who do not receive prophylactic ondansetron injection, USP and experience nausea and/or vomiting postoperatively, ondansetron injection, USP may be given to prevent further episodes (see CLINICAL TRIALS).
Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Vomiting -- The forcible expulsion of the contents of the STOMACH through the MOUTH.

Contraindications
Ondansetron Injection, USP is contraindicated for patients known to have hypersensitivity to the drug.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonist.
Branded Drugs
The following US Branded drugs contain Ondansetron


ZOFRAN ODT -- GLAXOSMITHKLINE


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