Description
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.
This product is available in the following dosage forms:
- Tablet, Disintegrating
- Film
- Tablet
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ondansetron in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Apomorphine
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mavorixafor
- Mesoridazine
- Phenelzine
- 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.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acecainide
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Anagrelide
- Anileridine
- Apalutamide
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azathioprine
- Azimilide
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Benzphetamine
- Bretylium
- Brompheniramine
- Buprenorphine
- Bupropion
- Buserelin
- Buspirone
- Butorphanol
- Capmatinib
- Carbamazepine
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 stomach)—May cover up symptoms of these stomach or intestinal problems, especially in patients who had a recent stomach surgery.
- Bradyarrhythmia (slow heartbeat) or
- 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)—Use is not recommended in patients with this condition.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.
Proper Use
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.
This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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.
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 and children 12 years of age and older—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 prevention of moderate nausea and vomiting after treatment with cancer medicines:
- For oral dosage form (soluble film):
- For prevention of moderate nausea and vomiting after treatment with cancer medicines:
- Adults and children 12 years of age and older—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.
- For prevention of moderate nausea and vomiting after treatment with cancer medicines:
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
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, which 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 including QT prolongation.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may cause a serious heart problem called myocardial ischemia (low blood supply to the heart). Check with your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, irregular heartbeat, or vomiting.
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
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
- trouble breathing
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, discomfort, tightness, or heaviness
- 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
- seizures
- skin rash, hives, or itching
- sweating
- total body jerking
- unusual tiredness or weakness
Incidence not known
- Agitation
- blistering, peeling, or loosening of the skin
- blurred vision
- chills
- diarrhea
- 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 pulse or blood pressure
- noisy breathing
- overactive reflexes
- pain or discomfort in the arms, jaw, back, or neck
- poor coordination
- pounding heartbeat
- red irritated eyes
- red skin lesions often with a purple center
- restlessness
- shivering
- slow or irregular breathing
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sticking out of the tongue
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- trouble with speaking
- twitching
- unconscious
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- vomiting
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
- shaking
- trouble sleeping
Rare
- Difficulty with speaking
- drooling
- loss of balance control
- muscle trembling, jerking, or stiffness
- shuffling walk
- stiffness of the limbs
- 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
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.
DRG-20074421
