Ondansetron Injection USP -(Preservative Free): Uses, Side Effects and Dosage

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 called antiemetics.

Ondansetron Injection USP 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 anaesthesia 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 Injection USP 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 USP if:

• you have a history of hypersensitivity (an allergic reaction) to any ingredient (see What the medicinal ingredient and nonmedicinal ingredients are) in Ondansetron Injection USP.
• if you are taking apomorphine (used to treat Parkinson’s disease).

What the medicinal ingredient is:

Ondansetron Injection USP contains ondansetron hydrochloride dihydrate as the medicinal ingredient.

What the nonmedicinal ingredients are:

Ondansetron Injection USP contains the following non-medicinal ingredients: citric acid monohydrate, sodium citrate dihydrate, sodium chloride and water. The multidose vials also contain methylparaben and propylparaben as preservative agents.

What dosage forms it comes in:

Ondansetron 2 mg/mL (as hydrochloride dihydrate) for intravenous use is supplied in single dose vials of 2 mL (4 mg) and 4 mL (8 mg) vials, in boxes of 5 vials and in multi-dose vials of 20 mL (40 mg), packed in individual cartons.

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 USP.
• If you have had an allergic reaction to medicines similar to 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/QTc prolongation or a family history of QT/QTc 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, contact your doctor immediately.

When given intravenously, ondansetron 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 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 Ondansetron Injection USP 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 USP 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 USP is not self administered by individuals. It should be administered under the supervision of a health professional.

Usual dose

Chemotherapy Induced Nausea and Vomiting:

You will receive Ondansetron Injection USP 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 intravenous dose of Ondansetron Injection USP is between 8 and 16 mg before your chemotherapy. You may also receive ondansetron to be taken 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 Ondansetron Injection USP. 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 USP, 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.

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

HOW TO STORE IT

Ondansetron Injection USP should be stored between 2 and 25 °C. Ondansetron Injection USP should not be frozen and should be protected from light.

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 found by contacting the sponsor, Hospira Healthcare Corporation at: 1-866-488-6088

Hospira Healthcare Corporation

Saint-Laurent, QC, H4S 0A9

Last revised: April 7, 2016.