Patient Medication Information: uses, side effects, how to take - Ondansetron Injection, USP (Baxter, 4 mg, 8 mg)
What is Ondansetron Injection, USP used for?
Children (4 to 17 years of age):
Ondansetron Injection, USP is used to prevent nausea and vomiting during chemotherapy.
Adults (18 to 64 years of age): Ondansetron Injection, USP is used:
- to prevent nausea and vomiting during chemotherapy, and
- to prevent or treat nausea and vomiting after surgery.
Geriatrics (65 years of age and older):
Ondansetron Injection, USP is used to prevent nausea and vomiting during chemotherapy.
How does Ondansetron Injection, USP work?
Ondansetron Injection, USP is a medicine known as an antiemetic. Treatments such as cancer chemotherapy are associated with the release of a natural substance (serotonin). The release of serotonin can make you feel sick and vomit. The way that Ondansetron Injection, USP works is not known, but it is thought to help stop the effects of serotonin to reduce the effects of nausea and vomiting.
What are the ingredients in Ondansetron Injection, USP?
Medicinal ingredient: ondansetron hydrochloride dihydrate
Non-medicinal ingredients: citric acid monohydrate, sodium chloride, and sodium citrate and water for injection.
Ondansetron Injection, USP comes in the following dosage forms:
Solution for Injection: 2 mg / mL of ondansetron (as ondansetron hydrochloride dihydrate).
Do not use Ondansetron Injection, USP, if:
- you are allergic to ondansetron hydrochloride dihydrate, or to any other ingredients in Ondansetron Injection, USP.
- you are taking a medicine called apomorphine (used to treat Parkinson’s disease).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Ondansetron Injection, USP. Talk about any health conditions or problems you may have, including if you:
- have had an allergic reaction to medicines that are similar to Ondansetron Injection, USP, such as medicines containing granisetron or palonosetron.
- are pregnant or planning to become pregnant. Ondansetron Injection, USP is not recommended for use during pregnancy.
- are breast feeding or planning to breastfeed. Ondansetron Injection, USP can pass into your breast milk and affect your baby.
- have liver problems.
- have signs of intestinal obstruction or blockage.
have or have had heart or blood vessel problems, including if you are at a higher risk for these problems. Risk factors include, but are not limited to, if you:
- have family members who have or have had heart or blood vessel problems,
- smoke,
- have high blood pressure,
- have high cholesterol levels,
- have diabetes, or
- are overweight.
- are taking medicines that affect the serotonin in your body (e.g., serotonergic and neuroleptic medications). If you are unsure, ask your healthcare professional.
- have QT/QTc prolongation (a heart rhythm condition) or a family history of QT/QTc prolongation.
- are taking medications that may lead to QT/QTc prolongation or electrolyte imbalances. If you are unsure, ask your healthcare professional.
- have low blood levels of potassium, magnesium, or calcium.
Other warnings you should know about:
Serotonin syndrome: Ondansetron Injection, USP can cause serotonin syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin syndrome if you take Ondansetron Injection, USP with certain antidepressants or migraine medications.
Serotonin syndrome symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Myocardial ischemia (lack of blood flow to the heart): Treatment with Ondansetron Injection, USP can cause myocardial ischemia which can lead to a heart attack. This may happen shortly after Ondansetron Injection, USP administration. Some symptoms of myocardial ischemia can include sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, and sudden heavy sweating. Your healthcare professional will monitor your health during and after administration of Ondansetron Injection, USP. However, if you notice any symptoms of myocardial ischemia, tell your healthcare professional right away. They may reduce or stop your treatment and may recommend another therapy.
QT/QTc prolongation: Ondansetron Injection, USP can affect the electrical activity of your heart known as QT/QTc prolongation. This effect can be measured with an electrocardiogram (ECG). In rare cases, QT/QTc prolongation can cause changes to the rhythm of your heart (e.g., fast, slow or irregular heartbeats). This can lead to dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or death. You are at a higher risk if you have a heart disease, are taking certain interacting medicines, are a female, or are over the age of 65 years. It is important to follow the instructions of your healthcare professional with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm problem, you should seek immediate medical attention.
Severe allergic reactions: Ondansetron Injection, USP can cause allergic reactions in certain individuals. Symptoms of a severe allergic reaction can include wheezing, sudden chest pain, tightness of the chest, heart throbbing, swelling of eyelids, face or lips, or develop a skin rash, skin lumps or hives. If you notice any signs of a severe allergic reaction, contact your healthcare professional immediately. Do not take any more medicine unless your healthcare professional tells you to do so.
Pregnancy:
- If you are pregnant, there are specific risks for your unborn baby that you must discuss with your healthcare professional.
- If you are able to get pregnant, you may be asked to take a pregnancy test before starting your treatment with Ondansetron Injection, USP.
- You should use effective birth control while you are taking Ondansetron Injection, USP, and for at least 2 days after stopping Ondansetron Injection, USP. Ask your healthcare professional about options of effective birth control.
- If you become pregnant while taking Ondansetron Injection, USP, tell your healthcare professional right away.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Ondansetron Injection, USP:
- medicines called CYP3A4 inducers (e.g., phenytoin, carbamazepine, and rifampicin);
- medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, and propafenone);
- medicines used to treat vomiting and nausea called antiemetics (e.g., dolasetron, palonosetron, granisetron, droperidol, chlorpromazine, prochlorperazine, and domperidone);
- medicines called tyrosine kinase inhibitors (e.g., vandetanib, sunitinib, nilotinib, and lapatinib);
- medicines used to manage psychosis or schizophrenia called antipsychotics (e.g., chlorpromazine, pimozide, haloperidol, and ziprasidone);
- medicines used to treat depression called antidepressants (e.g., citalopram, fluoxetine, venlafaxine, tricyclic/tetracyclic antidepressants, amitriptyline, imipramine, and maprotiline);
- medicines used to treat pain called opioids (e.g., methadone and tramadol);
- medicines used to treat bacterial infections called antibiotics (e.g., erythromycin, clarithromycin, telithromycin, tacrolimus, moxifloxacin, levofloxacin, and ciprofloxacin);
- medicines used to treat malaria called antimalarials (e.g., quinine and chloroquine);
- medicines used to treat fungal infections called azole antifungals (e.g., ketoconazole, fluconazole, and voriconazole);
- medicines used to treat cancer (e.g., vorinostat);
- medicines called beta-2 adrenoceptor agonists (e.g., salmeterol and formoterol);
- medicines that can affect electrolyte levels (e.g., diuretics, laxatives, enemas, amphotericin B, and high doses of corticosteroids);
- a medicine used to treat Parkinson’s Disease called apomorphine;
- medicines called serotonergic drugs that can affect the serotonin in the body (e.g., triptans, Selective Serotonin-Reuptake Inhibitors (SSRIs), Serotonin Noradrenalin Reuptake Inhibitors (SNRIs), lithium, sibutramine, fentanyl and its analogues, dextromethorphan, tramadol, tapentadol, meperidine, methadone, pertazocine, St. John’s Wort (Hypericum perforatum), monoamine oxidase inhibitors (MAOIs), linezolid, and methylene blue).
If you are unsure about any medications you are taking, ask your healthcare professional.
How to take Ondansetron Injection, USP:
Ondansetron Injection, USP will be prepared and administered by a healthcare professional or under the supervision of a healthcare professional.
Usual dose:
Your healthcare professional will determine the right dose and length of Ondansetron Injection, USP for you. Your dose will depend on your medical condition, age, current health, and if you take certain other medications. Your healthcare professional may monitor your health throughout your treatment and may interrupt, reduce or stop your dose.
Overdose:
If you think you, or a person you are caring for, have taken too much Ondansetron Injection, USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using Ondansetron Injection, USP?
These are not all the possible side effects you may have when taking Ondansetron Injection, USP. If you experience any side effects not listed here, tell your healthcare professional.
Some side effects may include:
- feeling of flushing or warmth;
- pain, redness, and burning at the site of injection;
- hiccups.
If you feel unwell or have any symptoms that you do not understand, tell your healthcare professional immediately.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
| Only if severe | In all cases | |
| UNCOMMON | ||
| Heart problems (disorders affecting your heart muscle, valves or rhythm): chest pain, chest discomfort, high blood pressure, irregular heart rhythm, shortness of breath, or fainting. | ||
| √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Seizures: loss of consciousness with uncontrollable shaking visual disturbances (e.g., blurred vision). | √ | ||
| Movement disorders (including dyskinesia): loss of coordination or balance, speech or limb movements, muscle spasms, difficultly walking, tremor, upward rolling of the eyes, or abnormal muscular stiffness. | √ | ||
| RARE | |||
| Eye problems such as blurred vision | √ | ||
| Immediate severe allergic reaction: swelling of the mouth, throat, difficulty in breathing, rash, hives, or increased heart rate. | √ | ||
| Serotonin syndrome: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (> 38°C), or rigid muscles. | √ | ||
| Liver problems: yellowing of your skin and eyes (jaundice), unusual dark urine and pale stools, pain or swelling in the right upper abdomen, unusual tiredness, nausea, or vomiting. | √ | ||
| Hypokalemia (low level of potassium in the blood): muscle weakness, muscle spasms, cramping, constipation, feeling of skipped heart beats or palpitations, fatigue, tingling, or numbness | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Prolongation of QT interval (a heart rhythm condition): irregular heartbeat, palpitations, dizziness, fainting, loss of consciousness, or seizures. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, or vomiting. | √ | ||
| Myocardial ischemia (lack of blood flow to the heart which can lead to heart attack): sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, or sudden heavy sweating. | √ | ||
| VERY RARE | |||
| Eye problems such as temporary blindness | √ | ||
| Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (severe skin reactions): redness, blistering or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, fever, chills, headache, cough, body aches, or swollen glands. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Ondansetron Injection, USP should be stored between 15⁰C to 30°C. Do not freeze. Protect from light.
Keep your medicine in a safe place out of reach and sight of children. Your medicine may harm them.
If you want more information about Ondansetron Injection, USP:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.baxter.ca, or by calling 1-888-719-9955
Baxter is a registered trademark of Baxter International Inc.