Details for: ONDANSETRON ODT
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02519232 | ONDANSETRON ODT | ONDANSETRON | 4 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
| 02519240 | ONDANSETRON ODT | ONDANSETRON | 8 MG | TABLET (ORALLY DISINTEGRATING) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
The name of your medicine is Ondansetron ODT orally disintegrating tablets (ondansetron). This medicine is one of a group called antiemetics
Ondansetron ODT is used for the:
- prevention of nausea (feeling of sickness) and vomiting during treatment for cancer (chemotherapy and radiotherapy).
- prevention and treatment of nausea and vomiting after surgery.
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 ODT helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used
Do not take Ondansetron ODT if you:
- have a history of hypersensitivity (an allergic reaction) to any ingredient in Ondansetron ODT.
- are taking apomorphine (used to treat Parkinson’s disease).
What the medicinal ingredient is
Ondansetron ODT orally disintegrating tablets contain ondansetron as the medicinal ingredient.
What the non-medicinal ingredients are
Ondansetron ODT orally disintegrating tablets contain the following nonmedicinal ingredients: aspartame, colloidal anhydrous silica, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, silicified microcrystalline cellulose strawberry flavour, modified food starch and triacetin.
What dosage form it comes in
Ondansetron ODT orally disintegrating tablets are supplied in two strengths, one contains 4 milligrams of ondansetron and the other contains 8 milligrams of ondansetron.
Warnings and precautions
Ondansetron ODT is not recommended for use during pregnancy.
Breastfeeding is not recommended during treatment with Ondansetron ODT. The ingredients can pass into your breast milk and may affect your baby.
Ondansetron ODT 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 ODT. You should use effective birth control during treatment with Ondansetron ODT. Ask your doctor about options of effective birth control.
BEFORE you use Ondansetron ODT talk to your doctor or pharmacist if you:
- have a history of hypersensitivity (an allergic reaction) to any ingredient in Ondansetron ODT.
- have had an allergic reaction to medicines similar to Ondansetron ODT 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 a condition called phenylketonuria and were prescribed Ondansetron ODT, because it contains aspartame.
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, contact your doctor immediately. Do not take any more medicine unless your doctor tells you to do so.
Serotonin Syndrome is a rare but potentially lifethreatening reaction that may occur if you take Ondansetron ODT 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 ODT 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
The label on the container of your medicine should tell you how often to take your medicine and how many doses you should take each time. If not, or if you are not sure, consult your doctor or pharmacist.
Do not take more doses, or take them more often than your doctor prescribes. If, however, you vomit within one hour of taking your medicine, you should take the same amount of medicine again. If vomiting persists, consult your doctor.
For Ondansetron ODT orally disintegrating tablets:
Do not try to push Ondansetron ODT through the lidding foil.
Tear along the perforations of the foil to separate off one tablet within its blister unit.
Peel back the foil at the place indicated by the arrow.
Gently push the Ondansetron ODT out of the blister pocket, and remove it with dry fingers.
Place the Ondansetron ODT on top of the tongue. It will dissolve very quickly. Swallow as normal.
Usual Dose:
Chemotherapy Induced Nausea and Vomiting Based on how likely you are to experience nausea and/or vomiting, caused by your cancer treatment, your doctor will tell you the amount you need to take and how frequently.
Adult: You may receive Ondansetron ODT before and/or after chemotherapy. The dose of Ondansetron ODT is between 8 and 24 mg a day (taken orally) for up to 5 days depending on the potential of your chemotherapy treatment to cause you to vomit and/or have nausea.
Children (4 to 12 years): After chemotherapy, take 4 mg orally every 8 hours for up to 5 days.
Radiotherapy Induced Nausea and Vomiting Adult: Take 8 mg orally 1 to 2 hours before radiotherapy. After therapy, take 8 mg orally every 8 hours for up to 5 days after a course of treatment.
Prevention of Post-Operative Nausea and Vomiting Adult: Take 16 mg orally one hour before anaesthesia.
If you have a liver problem, your dose may be altered. Please follow the instructions of your doctor.
Overdose:
Missed Dose
If you miss a dose and do not feel sick, take the next dose when it is due.
If you forget to take your medicine and feel sick or vomit, take a dose as soon as possible.
If your doctor decides to stop the treatment, do not keep any leftover medicine unless your doctor tells you to.
You may experience headaches, a feeling of warmness, flushing or constipation, while taking Ondansetron ODT. Although uncommon, low blood pressure and hiccups have also been reported.
There is no need to stop taking your medicine, but you should tell your doctor about these symptoms at your next visit.
If your nausea (feeling of sickness) or vomiting do not improve while taking Ondansetron ODT, 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.
Side effects and what to do about them
| Symptom / effect | Talk with your Doctor or Pharmacist | Stop taking drug and seek immediate emergency assistance | |
|---|---|---|---|
| Uncommon | |||
| Heart problems such as fast/slow heart-beat, 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 MARONDNASETRON ODT 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, diarrhoea, 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 ODT, contact your doctor or pharmacist.
How to store
Keep your medicine in a safe place where children cannot reach it. Your medicine may harm them.
Your Ondansetron ODT orally disintegrating tablets should be stored between 15°C -30°C.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about Ondansetron ODT:
- 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://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.jamppharma.ca, or by calling 1-866-399-9091.
This leaflet was prepared by
JAMP Pharma Corporation
Boucherville, Québec
J4B 5H3
Last Revised: August 13, 2021