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Ondansetron (Oral route, oromucosal route)

Pronunciation:

on-DAN-se-tron

Brand Names:

  • Zofran
  • Zofran ODT
  • Zuplenz

Dosage Forms:

  • Film
  • Tablet, Disintegrating
  • Tablet
  • Solution

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Serotonin Receptor Antagonist, 5-HT3

Uses of This Medicine:

Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation therapy. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ondansetron in children younger than 4 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ondansetron in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Apomorphine
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Bepridil
  • Bretylium
  • Bupropion
  • Carbamazepine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Deferasirox
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Droperidol
  • Ebastine
  • Enflurane
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isoflurane
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Mizolastine
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Paliperidone
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Pixantrone
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Salmeterol
  • Sematilide
  • Sertindole
  • Sertraline
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tedisamil
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cyclophosphamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to other selective 5-HT3 receptor antagonists (eg, alosetron [Lotronex®], dolasetron [Anzemet®], granisetron [Kytril®], palonosetron [Aloxi®])—Use with caution. It is likely you will also be allergic to ondansetron.
  • Bowel blockage or
  • Gastric distension (enlarged abdomen)—May cover up symptoms of these stomach or intestinal problems.
  • Congestive heart failure or
  • Heart rhythm problems (eg, prolonged QT interval, slow heartbeat) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May make these conditions worse.
  • Heart rhythm problems (eg, congenital long QT syndrome)—Avoid use in patients with this condition.
  • Liver disease—May have an increased chance of side effects.
  • Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To use the oral disintegrating tablet:

  • Make sure your hands are dry.
  • Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
  • Immediately place the tablet on top of the tongue. The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

To use the oral soluble film:

  • Make sure your hands are clean and dry before and after using this medicine.
  • Fold the pouch along the dotted line to expose the tear notch.
  • While still folded, tear the pouch carefully along the edge and remove the film out from the pouch.
  • Put the soluble film immediately on top of your tongue where it will dissolve in 4 to 20 seconds. Do not chew or swallow the film whole.
  • Once the film is dissolved, you may swallow with or without water.

If you vomit within 30 minutes after using this medicine, take the same amount of medicine again. If vomiting continues, check with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (oral disintegrating tablets, solution, or tablets):
    • For prevention of moderate nausea and vomiting after treatment with cancer medicines:
      • Adults, teenagers, and children 12 years of age—At first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. The 8-mg dose is taken again 8 hours after the first dose. Then, the dose is 8 mg every 12 hours for 1 to 2 days.
      • Children 4 to 11 years of age—At first, 4 mg taken 30 minutes before starting cancer treatment. The 4-mg dose is taken again 4 and 8 hours after the first dose. Then, the dose is 4 mg every 8 hours for 1 to 2 days.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For prevention of more severe nausea and vomiting after treatment with cancer medicines:
      • Adults, teenagers, and children 12 years of age—One 24-milligram (mg) tablet taken 30 minutes before starting cancer treatment.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For prevention of nausea and vomiting after radiation treatment:
      • Adults—At first, 8 milligrams (mg) taken 1 to 2 hours before radiation treatment. Then, the dose is 8 mg every 8 hours.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of nausea and vomiting after surgery:
      • Adults—16 milligrams (mg) one hour before anesthesia is given.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (soluble film):
    • For prevention of moderate nausea and vomiting after treatment with cancer medicines:
      • Adults, teenagers, and children 12 years of age—At first, one 8-milligram (mg) film taken 30 minutes before starting cancer treatment. The second 8-mg film is taken 8 hours after the first dose. Then, one 8-mg film is taken two times a day (every 12 hours) for 1 to 2 days.
      • Children 4 to 11 years of age—At first, one 4-milligram (mg) film taken 30 minutes before starting cancer treatment. The second and third 4-mg films are taken 4 and 8 hours after the first dose. Then, one 4-mg film is taken three times a day (every 8 hours) for 1 to 2 days.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For prevention of more severe nausea and vomiting after treatment with cancer medicines:
      • Adults—24 milligrams (mg) or three 8-mg films taken 30 minutes before starting cancer treatment. Each film should be dissolved in the tongue before taking the next film.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of nausea and vomiting after radiation treatment:
      • Adults—One 8-milligram (mg) film three times a day.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of nausea and vomiting after surgery:
      • Adults—16 milligrams (mg) or two 8-mg films taken 1 hour before anesthesia is given. Each film should be dissolved in the tongue before taking the next film.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage—

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the unused soluble film in the foil pouch until you ready to use it.

Precautions While Using This Medicine:

Check with your doctor if severe nausea and vomiting continue after leaving the hospital or cancer treatment center.

Do not use this medicine if you are receiving apomorphine (Apokyn®). Using these medicines together may increase risk for more serious problems.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor right away if you start to have pain or swelling in your stomach area. These may be signs of a serious stomach or bowel problem.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Confusion
dizziness
fast heartbeat
fever
headache
shortness of breath
weakness
Less common
Decrease in the frequency of urination
decrease in the urine volume
difficulty with passing urine (dribbling)
painful urination
Rare
Arm, back, or jaw pain
chest pain or discomfort
chest tightness or heaviness
convulsions
cough
decreased urine
difficulty with breathing
difficulty with swallowing
dry mouth
fast, pounding, or irregular heartbeat or pulse
increased thirst
loss of appetite
loss of bladder control
loss of consciousness
mood changes
muscle pain or cramps
nausea or vomiting
noisy breathing
numbness or tingling in the hands, feet, or lips
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash, hives, or itching
sweating
tightness in the chest
total body jerking
unusual tiredness or weakness
wheezing
Incidence not known
Blurred vision
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fixed position of the eye
heart stops
hoarseness
inability to move the eyes
increased blinking or spasms of the eyelid
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
no breathing
no pulse or blood pressure
noisy breathing
pounding heartbeat
slow or irregular breathing
sticking out of the tongue
sweating
trouble with speaking
unconscious
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual facial expressions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Anxiety
difficulty having a bowel movement (stool)
dry mouth
general feeling of discomfort or illness
hyperventilation
irritability
restlessness
shaking
trouble sleeping
Rare
Difficulty with speaking
drooling
loss of balance control
muscle trembling, jerking, or stiffness
shuffling walk
stiffness of the limbs
twisting movements of the body
uncontrolled movements, especially of the face, neck, and back
Incidence not known
Feeling of warmth
hiccups
redness of the face, neck, arms, and occasionally, upper chest
redness of the skin
welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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