Consumer Information for: ONDANSETRON INJECTION, USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

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

Ondansetron is used for:

  • the prevention of nausea (feeling of sickness) and vomiting during treatment for cancer (chemotherapy);
  • the prevention and treatment of nausea and vomiting after surgery.
What it does

Treatments such as general anaesthesia and cancer chemotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. Ondansetron 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 the Ondansetron Injection, USP;
  • 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 non-medicinal ingredients are

Ondansetron Injection, USP (preservative-free formulation, 2 mL and 4 mL ampoules and single-dose vials) contains: sodium chloride, citric acid (anhydrous), sodium citrate (dihydrate), water for injection. Ondansetron Injection, USP (preservative-containing formulation, 20 ml multiple-dose vials) contains: citric acid (monohydrate), methylparaben, propylparaben, sodium chloride, sodium citrate (dihydrate), water for injection.

What dosage form it comes in

Ondansetron Injection, USP 2 mg/mL (as hydrochloride dihydrate) preservative-free formulation is supplied in 2 mL (4 mg) and 4 mL (8 mg) ampoules and single-dose vials, in boxes of 5 vials; and the preservative-containing formulation is supplied in 20 mL (40 mg) multiple-dose vial, packed in individual carton.

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;
  • if you have had an allergic reaction to medicines similar to Ondansetron Injection, USP such as medicines containing granisetron or palonosetron.
  • you are pregnant or likely to become pregnant;
  • you are breast-feeding;
  • you have liver problems;
  • you have signs of intestinal obstruction;
  • you have a history of heart problems.
  • you have QT/QTc prolongation or a family history of QT/QTc prolongation.
  • you have low blood levels of potassium, magnesium, or calcium.

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.

When given intravenously, ondansetron has an effect on the electrical activity of the heart known as QT/QTc prolongation. This effect can be measured as a change in the electrocardiogram (ECG). In very rare cases, drugs with this effect on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. In general, females and people more than 65 years in age are at higher risk. It is important to follow the instructions of your doctor with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), or fainting, you should seek immediate medical attention.

Serotonin Syndrome is a rare but potentially life-threatening reaction that may occur if you take Ondansetron Injection, USP with certain other medications. It may cause serious changes in how your brain, muscles and digestive system work. Be sure to tell your healthcare professional all the medicines you are taking.

Interactions with this medication

As with most medicines, interactions with other drugs are possible. To avoid potentially life-threatening reactions tell your healthcare professional about ALL the medications you take, including those prescribed by other doctors, vitamins, minerals, natural supplements or alternative medicines. It is important that your doctor know about all your medication so that you get the best possible treatment. Tell your doctor if you are taking carbamazepine, phenytoin, or rifampicin. If you are taking any medicines containing tramadol, Ondansetron Injection, USP may decrease its effectiveness.

Also, make sure you tell your doctor or pharmacist if you are taking:

  • Drugs used to treat heart rhythm disorders
  • Antipsychotics
  • Antidepressants
  • Antibiotics or antifungals
  • Opiod analgesics (painkillers)
  • Other drugs to treat nausea and vomiting
  • Asthma drugs
  • Cancer drugs
  • Diuretics
  • Serotonergic drugs (including SSRIs*, SNRI’s**, and triptans) or drugs that significantly impair the metabolism of serotonin (such as MAOIs [including the antibiotic linezoid] and methylene blue)

*SSRI (Selective Serotonin-Reuptake Inhibitors) – used to treat depression or anxiety, e.g. escitalopram, citalopram, fluoxetine, paroxetine, sertaline.

**SNRI (Serotonin Noradrenalin Reuptake Inhibitors) – used to treat depression or anxiety, e.g. duloxetine, venlafaxine, desvenlafaxine.

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 regimen for you.

Adult: The single IV dose of Ondansetron Injection, USP is between 8 and 16 mg before your chemotherapy. You may also receive ondansetron orally after your chemotherapy.

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.

Although uncommon, low blood pressure and hiccups have also been reported.

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, tell your doctor immediately.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your Doctor Immediately
Uncommon
Heart problems such as fast/slow heartbeat, chest pain ✔
Seizures ✔
Upward rolling of the eyes, abnormal muscular stiffness/body movements/ shaking ✔
Rare
Eye problems such as blurred vision ✔
Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate ✔
Disturbance in heart rhythm (dizziness, palpitations, fainting ) ✔
Serotonin Syndrome: Symptoms of Serotonin Syndrome have been observed while taking Sandoz Ondansetron with certain other medications. Symptoms include:
  • agitation, confusion, restlessness, hallucinations, mood changes, unconsciousness, coma.
  • fast heartbeat, changes in blood pressure
  • Muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination
  • nausea, vomiting, diarrhea, fever, sweating, shivering.
 ✔
Very Rare
Eye problems such as temporary blindness ✔
Signs of serious skin reactions (skin rash, redness of the skin, blistering of the lips, eyes or mouth, and skin peeling.) ✔

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

How to store

Ondansetron Injection, USP should be stored between 15 and 30°C.

Ondansetron Injection, USP should not be frozen and should be protected from light. Ondansetron Injection, USP 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 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 three 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 ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6

Prepared on: March 19, 2015


Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca

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