Patient Medication Information: uses, side effects, how to take - Ondansetron Injection, USP (Agila Specialties Private)
ABOUT THIS MEDICATION
What the medication is used for:
The name of your medicine is Ondansetron Injection, USP. This medicine is one of a group of medicines called antiemetics.
Ondansetron is used for:
the prevention of nausea (feeling of sickness) and vomiting
associated with emetogenic chemotherapy, and radiotherapy;
the prevention and treatment of postoperative nausea and
vomiting.
What it does:
Treatments such as general anesthesia, 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 helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used:
Do not take ondansetron if:
you have a history of hypersensitivity (an allergic reaction) to
any ingredient (see “What the important nonmedicinal ingredients are”) in the product;
you are pregnant, or likely to become pregnant or if you are
breast-feeding a baby. However, there may be circumstances when your doctor advises you to use this medicine during pregnancy.
What the medicinal ingredient is:
Ondansetron Injection contains ondansetron (as ondansetron hydrochloride dihydrate) as the medicinal ingredient.
What the important nonmedicinal 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).
What dosage forms 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; $ you are pregnant, or likely to become pregnant; $ you are breast-feeding a baby;
$ you have liver problems;
$ you have signs of intestinal obstruction;
$ you have a history of heart problems.
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.
INTERACTIONS WITH THIS MEDICATION
It is important that your doctor know about all your medication so that you get the best possible treatment. Tell your doctor about all the medicines you are taking including those you have bought yourself. If you are taking any medicines containing tramadol (such as TRAMACET), Ondansetron Injection, USP may decrease its effectiveness.
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 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
You will receive Ondansetron Injection, USP prior to chemotherapy. 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: The dose of Ondansetron Injection will be between 8 and 32 mg a day depending on the potential of your chemotherapy treatment to cause you to vomit and/or have nausea. Children (4 to 12 years): Just before chemotherapy, infuse 3 to 5 mg/m2 over 15 minutes.
Postoperative Nausea and Vomiting
Adult: For prevention, 4 mg by slow i.v. injection at the induction of anesthesia. For treatment, 4 mg by slow i.v. injection.
If you have a liver problem, your dose may be altered. Please follow the instructions of your doctor.
Overdose:
In the event you accidentally take more doses than prescribed, immediately contact your doctor or hospital emergency department or nearest poison control centre.
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.
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. 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 Injection, 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Uncommon | Heart problems such as fast/slow heart beat, chest pain Seizures Upward rolling of the eyes, abnormal muscular | T | T T |
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| 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 | T | T |
| Very Rare | Eye problems such as temporary blindness | T | |
This is not a complete list of side effects. For any unexpected effects while taking Ondansetron Injection, USP, contact your doctor or pharmacist.
HOW TO STORE IT
Ondansetron Injection, USP should be stored between 15 and 30˚C.
Ondansetron Injection should not be frozen and should be protected from light. Ondansetron Injection must not be autoclaved.
Intravenous solutions should be prepared at the time of infusion. Ondansetron Injection, 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 SUSPECTED 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 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Report Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
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
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.
This document plus the full product monograph, prepared for health professionals, can be requested from:
AGILA SPECIALTIES PRIVATE LIMITED