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Ondansetron Injection USP (Accord Healthcare, PM 00015958): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Pre Market
Strength:
2 mg
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Ondansetron Injection USP (Accord Healthcare, PM 00015958)

ABOUT THIS MEDICATION

What the medication is used for:

The name of your medicine is Ondansetron Injection USP (ondansetron hydrochloride dihydrate). This medicine is one of a group called antiemetics.

Ondansetron Injection USP is used for:

  • the prevention of nausea (feeling of sickness) and vomiting

    associated with emetogenic chemotherapy and radiotherapy.

  • the prevention and treatment of post-operative nausea and

    vomiting.

What it does:

Treatments such as general anaesthesia, cancer chemotherapy and radiotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. Ondansetron Injection USP helps to stop this from happening, thus preventing you from vomiting or feeling sick.

When it should not be used:

Do not take Ondansetron Injection USP if:

  • you have a history of hypersensitivity (an allergic reaction) to

    any ingredient (see What the nonmedicinal ingredients are) in Ondansetron Injection USP.

  • if you are pregnant, or likely to become pregnant, or if you are

    breast feeding a baby. However, there may be circumstances when your doctor advises you to use this medicine during pregnancy.

  • if you are taking apomorphine (used to treat Parkinson’s disease).

What the medicinal ingredient is:

Ondansetron Injection USP contains ondansetron (as ondansetron hydrochloride dihydrate) as the medicinal ingredient.

What the nonmedicinal ingredients are:

Ondansetron Injection USP (as hydrochloride dihydrate) [preservative free]:

Ondansetron Injection USP (2 mL and 4 mL ampoules) contains the following nonmedicinal ingredients: citric acid monohydrate, sodium chloride, sodium citrate dihydrate, sodium hydroxide, hydrochloric acid and water for injection.

Ondansetron Injection USP (as hydrochloride dihydrate) [with preservatives]:

Ondansetron Injection USP (20 mL vial) contains the following nonmedicinal ingredients: methylparaben (as preservative), propylparaben (as preservative), citric acid monohydrate, sodium chloride, sodium citrate dihydrate and water for injection.

What dosage forms it comes in:

Ondansetron Injection USP (as hydrochloride dihydrate) [preservative free]:

Ondansetron 2 mg/mL (as hydrochloride dihydrate) for intravenous use is supplied in 2 mL (4 mg) and 4 mL (8 mg) ampoules, in a plastic tray of 10 ampoules, packed in a carton.

Ondansetron Injection USP (as hydrochloride dihydrate) [with preservatives]:

Ondansetron 2 mg/mL (as ondansetron hydrochloride dihydrate) for intravenous use is supplied in 20 mL (40 mg) packed in individual cartons.

WARNINGS AND PRECAUTIONS

BEFORE you use Ondansetron Injection USP talk to your doctor or pharmacist if:

  • you have a history of hypersensitivity (an allergic reaction)

    to any ingredient in Ondansetron Injection USP.

  • you are pregnant or likely to become pregnant.
  • you are breast feeding a baby.
  • you have liver problems.
  • you have signs of intestinal obstruction.
  • you have a history of heart problems.

If you experience wheezing and tightness of the chest, heart throbbing, swelling of eyelids, face or lips, or develop a skin rash, skin lumps or hives, tell your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

It is important that your doctor know about all your medication so that you get the best possible treatment. Tell your doctor about all the medicines you are taking including those you have bought yourself. If you are taking any medicines containing tramadol, Ondansetron Injection USP may decrease its effectiveness.

PROPER USE OF THIS MEDICATION

Ondansetron Injection USP is not self administered by individual. It should be administered under the supervision of a health professional.

Usual dose:

Chemotherapy Induced Nausea and Vomiting You will receive Ondansetron Injection USP by intravenous infusion. Based on how likely you are to experience nausea and/or vomiting, caused by your cancer treatment, your doctor will determine the appropriate dose for you.

IMPORTANT:PLEASE READ

March 20, 2012 Page 26 of 26

Adult: The dose of Ondansetron Injection USP will be between 8 and 32 mg before your chemotherapy, depending on the potential of your chemotherapy treatment to cause you to vomit and/or have nausea. You may also receive Ondansetron Injection USP after your chemotherapy. The total daily dose does not exceed 32 mg.

Children (4 to 12 years): The dose is 3 to 5 mg/m2 just before chemotherapy.

Post-Operative Nausea and Vomiting:

Adult: For prevention of post operative nausea and vomiting, the dose is 4 mg at the time of surgery. For treating post operative nausea and vomiting, the dose is 4 mg after surgery.

If you have a liver problem, your dose may be altered.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

You may experience headaches, a feeling of warmness, flushing or constipation, while taking Ondansetron Injection USP. You may also experience pain, redness and burning at the injection site.

If your nausea (feeling of sickness) or vomiting do not improve while taking Ondansetron Injection USP, consult your doctor for further advice.

If you feel unwell or have any symptoms that you do not understand, you should contact your doctor immediately.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
FrequencySide Effect/ SymptomsTalk with
your Doctor
immediately
UncommonHeart problems such asX
fast/slow heart beat, chest pain
SeizuresX
Upward rolling of the eyes,X
abnormal muscular
stiffness/body
movements/shaking
RareEye problems such as blurredX
vision
Immediate allergic reaction andX
symptoms such as swelling of
the mouth, throat, difficulty in
breathing, rash, hives, increased
heart rate
Disturbance in heart rhythmX
(sometimes a sudden loss of
consciousness)
Very RareEye problems such asX
temporary blindness

This is not a complete list of side effects. For any unexpected effects while taking Ondansetron Injection USP, contact your doctor.

HOW TO STORE IT

Ondansetron Injection USP should be stored between 15°C – 30°C. It should not be frozen and it should be protected from light. Injection must not be autoclaved.

Intravenous solutions should be prepared at the time of infusion. Ondansetron Injection USP, when diluted with the recommended intravenous solutions, should be used within 24 hours if stored at room temperature or used within 72 hours if stored in a refrigerator, due to possible microbial contamination during preparation.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: --------------------------------------------------------------------------

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345

  • Complete a Canada Vigilance Reporting Form and:

    • Fax toll-free to 1-866-678-6789, or

    • Mail to: Canada Vigilance Program Health Canada

      Postal Locator 0701E

      Ottawa, Ontario

      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This leaflet does not contain the complete information about your medicine. If any questions remain unanswered or you are not sure about something, you should ask your doctor or pharmacist.

This document plus the full product monograph, prepared for health professionals can be found by contacting sponsor,

Accord Healthcare Inc.

3100 Steeles Ave E., Unit # 605

Markham ON L3R8T3

Canada

Tel: 1-866-296-0354

Last revised: March 21, 2012

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02382121

Revision date stated in the text: March 21, 2012

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ondansetron Injection USP (Accord Healthcare, PM 00015958)

Rx or OTC
Prescription (Rx)?
DIN 02382121
Schedule(s) PRESCRIPTION
Active ingredient(s) Ondansetron (ondansetron hydrochloride dihydrate) 2 MG
Dosage form(s) Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. A Alimentary tract and metabolism drugs
    1. A04 Antiemetics and antinauseants
      1. A04A Antiemetics and antinauseants
        1. A04AA Serotonin (5HT3) antagonists, antiemetics and antinauseants
          1. A04AA01 Ondansetron
Company ACCORD HEALTHCARE INC
Current status Cancelled Pre Market
Current status date August 7, 2017

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.