The reference site for Ondansetron

Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery.

WHAT IS Ondansetron?

Ondansetron is a serotonin 5-HT3 receptor antagonist used mainly to treat nausea and vomiting following chemotherapy.

Its effects are thought to be on both peripheral and central nerves. One part is to reduce the activity of the vagus nerve, which is a nerve that activates the vomiting center in the medulla oblongata, the other is a blockage of serotonin receptors in the chemoreceptor trigger zone.

However, this medication does not have much effect on vomiting due to motion sickness, nor does it have any effect on dopamine receptors or muscarinic receptors.

It is currently marketed by GlaxoSmithKline under the trade name Zofran®. Other manufacturers include Cipla Ltd. (Emeset®), Gedeon Richter Ltd. (Emetron®), and Zentiva a.s. (Ondemet®).

 

Brand Name(s): Zofran; Emeset; Emetron; Ondemet
CAS nº: 99614-02-5
(on DAN se tron)

 

Product Info

The sections below will provide you with more specific information and guidelines related to ondansetron and its correct use. Please read them carefully.

FDA Information

Ondansetron was developed around 1984 by scientists working at Glaxo’s laboratories in London.

After several attempts the company successfully filed for U.S. patent protection for the drug in 1986. Patents were granted as folows:
U.S. Patent 4,695,578 was granted in September 1987.
U.S. Patent 4,753,789 was granted in June 1988.
U.S. Patent 5,578,628 (a divisional patent of U.S. Patent 4,753,789), was granted in November 26th 1996.

Ondansetron was granted FDA approval as Zofran® in January 1991. Glaxo did pediatric research on Zofran’s uses, and gained patent extension as a result. Consequently U.S. exclusivity is now set to end on December 24th 2006.

On May 29th, 2006, Baxter Healthcare received tentative approval to market its own label of ondansetron injection, USP, 8 mg/50 mL and 32 mg/50 mL iso-osmotic sodium chloride solution, after GSK’s patent expires in December.

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

Ondansetron is a serotonin 5-HT3 receptor antagonist used mainly to treat nausea and vomiting following chemotherapy.

Its effects are thought to be on both peripheral and central nerves. One part is to reduce the activity of the vagus nerve, which is a nerve that activates the vomiting center in the medulla oblongata, the other is a blockage of serotonin receptors in the chemoreceptor trigger zone.

This medication does not have much effect on vomiting due to motion sickness, nor does it have any effect on dopamine receptors or muscarinic receptors.

Other uses for this medicine

Ondansetron oral may also be used to treat alcoholism.

However, it is important that you talk to your doctor about the possible risks of using this drug for your particular condition.

Dosage and using this medicine

Ondansetron comes as an injection or as a tablet, liquid, or dissolving tablet to be taken orally.

For ondansetron INJECTION:

Ondansetron injection is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

In most cases, only one dose of ondansetron injection is given just before the start of surgery or chemotherapy. Sometimes a second and third dose are also given at 4 hours and 8 hours after the first dose.

The medicine must be given through an IV infusion, and can take up to 15 minutes to complete.

Ondansetron injection is not for preventing nausea or vomiting that are caused by factors other than chemotherapy or surgery.

For Ondansetron ORAL:

Take ondansetron exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each regular tablet with a full glass of water.

The ondansetron orally disintegrating tablets (Zofran ODT®) can be taken with or without water. Do not remove the tablet from the blister until immediately before taking a dose. Moreover, do not try to push the tablet through the foil backing, as the tablet may break. With dry hands, peel back the foil backing of one blister and gently remove the tablet. Then, place the tablet immediately on your tongue where it will dissolve in seconds, then swallow with saliva. Administration with water is not necessary.

To ensure that you get a correct dose, measure the liquid form of ondansetron with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Ondansetron can be taken with or without food.

What special precautions should I follow?

BEFORE TAKING ONDANSETRON:

Tell your doctor if you have liver disease, a history of allergic reaction to any medicine similar to ondansetron, including dolasetron (Anzemet®), granisetron (Kytril®), or palonosetron (Aloxi®), or a personal or family history of Long QT syndrome. If you have any of these conditions, you may not be able to use ondansetron injection, or you may need a dosage adjustment or special tests during treatment.

Before receiving ondansetron injection, please inform your doctor if you are using any of the following medication: phenytoin (Dilantin®), phenobarbital (Luminal®); carbamazepine (Carbatrol®, Tegretol®); tramadol (Ultram®); rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®, Rifater®); amiodarone (Cordarone®), mibefradil (Posicor®); cimetidine (Tagamet®); clarithromycin (Biaxin®), erythromycin (E.E.S.®, E-Mycin®, Ery-Tab®); or HIV medicines such as indinavir (Crixivan®), saquinavir (Invirase®), ritonavir (Norvir®), or nelfinavir (Viracept®). If you are using any of these drugs, you may not be able to use ondansetron injection, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ondansetron injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without first telling your doctor.

This medication falls into the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Furthermore, ondansetron can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by ondansetron injection.

Ondansetron can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I do if I forget a dose?

For ondansetron INJECTION:

Call your doctor for instructions.

For ondansetron ORAL:

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose.

It is strongly advised never to take a double dose of this medication.

What side effects can this medication cause?

Get emergency medical help if you have any of these signs of an allergic reaction:

hives
difficulty breathing
swelling of your face, lips, tongue, or throat

Call your doctor at once if you have any of these serious side effects:

For ondansetron INJECTION:
– muscle spasm or twitching, especially in your face
– stiffness in your neck

For ondansetron ORAL:
– irregular heartbeats
– muscle cramps or uncontrollable movements

Other less serious side effects are more likely to occur, such as:

For ondansetron INJECTION:
– diarrhea
– headache
– fever
– drowsiness
– blurred vision
– pain or redness where the medicine is injected

For ondansetron ORAL:

– headache
– fatigue, drowsiness, or dizziness
– anxiety or agitation
– diarrhea or constipation

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What storage conditions are needed for this medicine?

If you receive ondansetron injection at home and you keep your medicine there, store it at room temperature away from heat and light. The same is required for ondansetron tablets.

Please remember to keep this medication out of reach of children, and throw away any medication that is outdated or no longer needed. If you have any questions, talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of an overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, please call the local emergency services immediately on 911.

Symptoms of overdose may include:

For ondansetron INJECTION:
– change in vision
– severe constipation
– severe dizziness
– irregular heartbeat

For ondansetron ORAL:
– headache
– temporary blindness
– constipation
– faintness
– heart problems

Product Images

PICTURES OF ONDANSETRON PILLS

Below you will find images and specific information on the principal types of ondansetron that exist, including their respective brand name(s), strength, inscription codes, manufacturers and/or distributors.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

Name: ZOFRAN®
Strength(s): 8 MG
Imprint: ZOFRAN | 8
Manufacturer: GLAXOSMITHKLINE

Name: ZOFRAN®
Strength(s): 24 MG
Imprint: GX CF7 | 24
Manufacturer: GLAXOSMITHKLINE

Name: ZOFRAN®
Strength(s): 2 MG / ML
Imprint: ZOFRAN INJECTION
Manufacturer: GLAXOSMITHKLINE

Name: ZOFRAN®
Strength(s): 24 MG
Imprint: ZOFRAN ORAL SOLUTION
Manufacturer: GLAXOSMITHKLINE

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