Jamp-Ondansetron (Jamp Pharma, 2 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The name of your medicine is JAMP-Ondansetron (ondansetron hydrochloride dehydrate). This medicine is one of a group of medicines called antiemetics.

Ondansetron is used for:

• the prevention of nausea (feeling of sickness) and vomiting

  during treatment for cancer (chemotherapy);

• the prevention and treatment of nausea and vomiting after

  surgery.

What it does:

Treatments such as general anesthesia and cancer chemotherapy 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 JAMP-Ondansetron if:

• you have a history of hypersensitivity (an allergic reaction) to

  any ingredient (see “What the nonmedicinal ingredients are”) in the JAMP-Ondansetron;

• if you are taking apomorphine (used to treat Parkinson’s

  disease).

What the medicinal ingredient is:

JAMP-Ondansetron contains ondansetron (as ondansetron hydrochloride dihydrate) as the medicinal ingredient.

What the nonmedicinal ingredients are:

JAMP-Ondansetron (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.

JAMP-Ondansetron (preservative-containing formulation, 20 ml multiple-dose vials) contains: citric acid (monohydrate), methylparaben, propylparaben, sodium chloride, sodium citrate

(dihydrate), water for injection.

What dosage forms it comes in:

JAMP-Ondansetron 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 JAMP-Ondansetron talk to your doctor or pharmacist if:

• you have a history of hypersensitivity (an allergic reaction) to any ingredient in JAMP-Ondansetron;
• if 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.

• you have QT/QT_c prolongation or a family history of

  QT/QT_c prolongation.

• you 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 has an effect on the electrical activity of the heart known as QT/QT_c 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 heart beat), or fainting, you should seek immediate medical attention.

Serotonin Syndrome is a rare but potentially life-threatening 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
• Antipsychotics
• Antidepressants
• Antibiotics or antifungals
• Opiod analgesics (painkillers)
• Other drugs to treat nausea and vomiting
• Asthma drugs
• Cancer drugs
• Diuretics

• Serotonergic drugs (including SSRIs*, SNRI’s**, and

  triptans) or drugs that significantly impair the metabolism of serotonin (such as MAOIs [including the antibiotic linezoid] and methylene blue)

*SSRI (Selective Serotonin-Reuptake Inhibitors) – used to treat depression or anxiety, e.g. escitalopram, citalopram, fluoxetine, paroxetine, sertaline.

**SNRI (Serotonin Noradrenalin Reuptake Inhibitors) – used to treat depression or anxiety, e.g. duloxetine, venelaxafine, desvenlaxafine.

PROPER USE OF THIS MEDICATION

JAMP-Ondansetron 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 JAMP-Ondansetron 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 JAMP-Ondansetron is between 8 and 16 mg before your chemotherapy. You may also receive ondansetron orally after 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 JAMP-Ondansetron. You may also experience pain, redness and burning 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 JAMP-Ondansetron, consult your doctor for further advice.

If you feel unwell or have any symptoms that you do not understand, tell your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking JAMP-Ondansetron, contact your doctor.

HOW TO STORE IT

JAMP-Ondansetron should be stored between 15 and 30˚C.

JAMP-Ondansetron should not be frozen and should be protected from light. JAMP-Ondansetron must not be autoclaved.

Intravenous solutions should be prepared at the time of infusion. JAMP-Ondansetron, 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 Reporting 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 MedEffect^TM 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

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.

This document plus the full product monograph, prepared for health professionals, can be requested from:

Jamp Pharma Corporation

203-1380 Newton

Boucherville, Québec J4B 5H2

Jamp Pharma Corporation

Last revised: March 17, 2015.