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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ONDANSETRON DISINTEGRATING TABLET - ORAL

(on-DANCE-eh-tron)

COMMON BRAND NAME(S): Zofran ODT

USES: This medication is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy. It is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body's natural substances (serotonin) that causes vomiting.

Ondansetron belongs to a class of medications called 5-HT3 blockers.

HOW TO USE: This medication is dissolved on top of the tongue. It is not meant to be chewed or swallowed like other tablet forms.

Dry your hands before using this medication. This medication may come in a bottle or a blister pack. If using the blister pack, peel back the foil on the blister pack to remove a tablet. Do not push the tablet through the foil. Immediately after removing the tablet, place it on the tongue. Allow it to dissolve completely, then swallow it with saliva. You do not need to take this product with water. Doing so may increase your chance of getting a headache.

To prevent nausea from chemotherapy, take this medication usually within 30 minutes before treatment begins. To prevent nausea from radiation treatment, take this medication 1 to 2 hours before the start of your treatment. To prevent nausea after surgery, take ondansetron 1 hour before the start of surgery. This medication may be taken with or without food. However, your doctor may tell you not to eat before chemotherapy, radiation, or surgery.

Take any other doses as directed by your doctor. Ondansetron may be taken up to 3 times a day for 1 to 2 days after your chemotherapy or radiation treatment is finished. If you are taking this medication on a prescribed schedule, take it regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

Dosage is based on your medical condition and response to therapy. The dosage for children may also be based on age and weight. In patients with severe liver problems, the usual maximum dose is 8 milligrams in 24 hours. Take this medication exactly as directed. Do not take more medication or take it more often than prescribed. Ask your doctor or pharmacist if you have questions.

Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Headache, lightheadedness, dizziness, drowsiness, tiredness, or constipation may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach pain, muscle spasm/stiffness, vision changes (e.g., temporary loss of vision, blurred vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fainting, slow/fast/irregular heartbeat, severe dizziness.

A very serious allergic reaction to this drug is unlikely, but stop taking this medication and seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ondansetron, tell your doctor or pharmacist if you are allergic to it; or to other 5-HT3 blockers (e.g., granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus, swelling).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist regarding the safe use of this medicine.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: apomorphine.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting ondansetron.

Before using this medication, tell your doctor of all nonprescription and prescription medication you may use, especially of: tramadol.

Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this product with others.

MISSED DOSE: Try to take each dose at the scheduled time. If you miss a dose, take it as soon as you remember unless it is near the time for the next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: The dissolving tablets may be stored in the refrigerator or at room temperature between 36-86 degrees F (2-30 degrees C).

Store away from light and moisture. Do not store in the bathroom. Keep all medicines out of reach of children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010 Copyright(c) 2010 First DataBank, Inc.

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