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(ondansetron hydrochloride) Injection
The active ingredient of ZOFRAN Injection is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:
The empirical formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.9.
Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline.
Each 1 mL of aqueous solution in the 20 mL multidose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers; and 1.2 mg of methylparaben, NF and 0.15 mg of propylparaben, NF as preservatives in Water for Injection, USP.
ZOFRAN Injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0.
What are the possible side effects of ondansetron (Zofran)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fast, slow, or uneven heartbeats;
- feeling like you might pass out; or
- headache with chest pain and severe dizziness, fainting, fast or pounding heartbeat.
Other common side effects may include:
- diarrhea, constipation;
- itching, numbness, or tingling;
- mild headache; or
- fever, or cold...
What are the precautions when taking ondansetron hydrochloride injection (Zofran Injection)?
Before using ondansetron, tell your doctor or pharmacist if you are allergic to it; or to other serotonin blockers (e.g., granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: irregular heartbeat, liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).
Ondansetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical...
Last reviewed on RxList: 12/23/2013
This monograph has been modified to include the generic and brand name in many instances.
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