Details for: JAMP ONDANSETRON
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02490617 | JAMP ONDANSETRON | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) | 4 MG / 5 ML | SOLUTION | 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 JAMP Ondansetron
Oral Solution (ondansetron hydrochloride dihydrate).
This medicine is one of a group called antiemetics.
JAMP Ondansetron is used for:
- 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 and radiotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. JAMP Ondansetron helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used
Do not take JAMP Ondansetron if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in JAMP Ondansetron.
- you are taking apomorphine (used to treat Parkinson’s disease).
What the medicinal ingredient is
JAMP Ondansetron Oral Solution contains ondansetron hydrochloride dihydrate as the medicinal ingredient.
What the non-medicinal ingredients are
JAMP Ondansetron Oral Solution contains the following nonmedicinal ingredients: citric acid, sodium benzoate, sodium citrate dihydrate, and strawberry flavour (contains a small amount of ethanol (alcohol)). JAMP Ondansetron Oral Solution is sucrosefree and is sweetened with sorbitol.
What dosage form it comes in
JAMP Ondansetron Oral Solution is supplied in one strength, 4 mg of ondansetron per teaspoon (5 mL), in bottles. Your doctor will decide how many teaspoons or milliliters you need.
Warnings and precautions
JAMP Ondansetron are not recommended for use
during pregnancy.
Breastfeeding is not recommended during treatment
with JAMP Ondansetron. The ingredients can pass
into your breast milk and may affect your baby.
JAMP Ondansetron 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 JAMP Ondansetron. You
should use effective birth control during treatment
with JAMP Ondansetron. Ask your doctor about
options of effective birth control.
BEFORE you use JAMP Ondansetron talk to your
doctor or pharmacist if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in JAMP Ondansetron.
- you have had an allergic reaction to medicines similar to JAMP Ondansetron 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.
Serotonin Syndrome is a rare but potentially lifethreatening reaction that may occur if you take JAMP Ondansetron 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,
JAMP Ondansetron 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
- Opiod 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.
**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.
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: Take 8 mg (10 mL or 2 teaspoons) 1 or 2 hours
before some forms of chemotherapy. After the first day
of chemotherapy, you can take 8 mg (10 mL or 2
teaspoons) orally every 8 hours for up to 5 days after a
course of treatment, 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 ( 5 mL or one tea spoon ) orally every 8
hours for up to 5 days.
Radiotherapy Induced Nausea and Vomiting
Adult:
Take 8 mg (10 mL or 2 teaspoons) orally 1 to 2
hours before radiotherapy. After therapy, take 8 mg
(10 mL or 2 teaspoons) 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 (20 mL or 4 teaspoons) 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.
Side effects and what to do about them
You may experience headaches, a feeling of warmness,
flushing or constipation, while taking JAMP
Ondansetron. 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 JAMP Ondansetron, 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.
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency assistance |
|---|---|---|
| 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 JAMP
Ondansetron with
certain other
medications.
Symptoms include:
|
✔ | |
| 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 JAMP Ondansetron, 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 JAMP Ondansetron Oral Solution should be kept
in its bottle, upright, between 15 and 30 °C. Do not
refrigerate.
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
Remember: This medicine is for you. Only a doctor
can prescribe it for you. Never give it to someone
else. It may harm them even if their symptoms are the
same as yours.
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.
You may want to read this leaflet again.
Please Do Not
Throw It Away until you have finished your medicine.
- 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://www.canada.ca/en/health-canada.html); or by contacting the sponsor, Jamp Pharma Corporation, at : 1866-399-9091.
1310 rue Nobel,
Boucherville, Québec,
Canada, J4B 5H3
This leaflet was prepared by Jamp Pharma Corporation.
Last revised: January 24, 2020