Patient Medication Information: uses, side effects, how to take - Ondansetron Injection BP (Auro Pharma)
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is Ondansetron Injection BP (ondansetron hydrochloride dihydrate). This medicine is one of a group called antiemetics.
Ondansetron Injection BP is used for the:
- the prevention of nausea (feeling of sickness) and vomiting during treatment for cancer (chemotherapy and radiotherapy).
- the prevention and treatment of nausea and vomiting after surgery.
What it does:
Treatments such as general anaesthesia, cancer chemotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. Ondansetron Injection BP 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 BP if you:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in Ondansetron Injection BP.
- you are taking apomorphine (used to treat Parkinson’s disease).
What the medicinal ingredient is:
Ondansetron Injection BP contains ondansetron (as ondansetron hydrochloride dihydrate) as the medicinal ingredient.
What the nonmedicinal ingredients are:
Ondansetron Injection BP may contain the following nonmedicinal ingredients: citric acid monohydrate, sodium chloride, sodium citrate (dihydrate), nitrogen and water for injection.
What dosage forms it comes in:
Ondansetron Injection is available as ondansetron 2 mg/mL (as hydrochloride dihydrate) for intravenous use.
WARNINGS AND PRECAUTIONS
Ondansetron Injection BP are not recommended for use during pregnancy.
Breastfeeding is not recommended during treatment with Ondansetron Injection BP. The ingredients can pass into your breast milk and may affect your baby.
Ondansetron Injection BP may harm your unborn baby. If you are a woman of childbearing age, your doctor or healthcare provider will check if you are pregnant and perform a pregnancy test if necessary before starting treatment with Ondansetron Injection BP. You should use effective birth control during treatment and for at least 2 days after stopping Ondansetron Injection BP. Ask your doctor about options of effective birth control.
BEFORE you use Ondansetron Injection BP talk to your doctor or pharmacist if you:
- have a history of hypersensitivity (an allergic reaction) to any ingredient in Ondansetron Injection BP.
- have had an allergic reaction to medicines similar to Ondansetron Injection BP such as medicines containing granisetron or palonosetron.
- are pregnant or likely to become pregnant.
- are breast feeding.
- have liver problems.
- have signs of intestinal obstruction.
- have a history of heart problems.
- have QT/QTc prolongation or a family history of QT/QTc prolongation
- 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 Injection BP 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 heartbeat), 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 BP 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 BP may decrease its effectiveness.
Also, make sure you tell your doctor or pharmacist if you are taking:
- Drugs used to treat heart rhythm disorders
- Other drugs that may disturb heart rhythm Antipsychotics
- Antidepressants
- Antibiotics or antifungals
- Opioid analgesics (painkillers)
- Other drugs to treat nausea and vomiting
Asthma drugs
- Cancer drugs
- Diuretics
- Other drugs that affect serotonin including SSRI*s, SNRI**s, triptans, MAOIs*** (including the antibiotic linezolid and methylene blue), drugs that contain tryptophan, or St. John’s Wort.
*SSRI (Selective Serotonin-Reuptake Inhibitors) – used to treat depression or anxiety, e.g. escitalopram, citalopram, fluoxetine, paroxetine, sertraline.
**SNRI (Serotonin Noradrenalin Reuptake Inhibitors) – used to treat depression or anxiety, e.g. duloxetine, venlafaxine, desvenlafaxine.
***MAOIs (Monoamine Oxidase Inhibitors) - used to treat depression, Parkinson’s disease, e.g., phenelzine, rasagiline, selegiline.
PROPER USE OF THIS MEDICATION
Ondansetron Injection BP 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 BP 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 BP is between 8 and 16 mg before 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 BP. You may also experience pain, redness and burning sensation 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 BP, 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
| Frequency | Side Effect/ Symptom | Talk with your health care professional Immediately |
|---|---|---|
| Uncommon | Heart problems such as fast/slow heartbeat, chest pain Seizures Upward rolling of the eyes, abnormal muscular stiffness / body movements / shaking | X X X |
| Frequency | Side Effect/ Symptom | Talk with your health care professional Immediately |
|---|---|---|
| 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 Ondansetron Injection BP with certain other medications. Symptoms include:
| X X X X |
| 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) | X X |
This is not a complete list of side effects. For any unexpected effects while taking Ondansetron Injection BP, contact your doctor.
HOW TO STORE IT
Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them.
Sterile solution for Intravenous Injection (Single Use):
Store at Controlled Room Temperature 15 to 30°C. Do not freeze. Protect from light.
Diluted Solutions:
Up to 24 hours at room temperature or 72 hours refrigerated.
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. |
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.
If you want more information about Ondansetron Injection BP:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada website (https://health-
- products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of revision: January 21, 2021