Anzemet Oral

Generic Name: dolasetron (Oral route)

doe-LAS-e-tron MES-i-late

Commonly used brand name(s)

In the U.S.

• Anzemet

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiemetic

Pharmacologic Class: Dolasetron

Uses For Anzemet

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

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

Before Using Anzemet

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dolasetron in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolasetron in the elderly. However, elderly patients are more likely to have heart rhythm problems (e.g., prolonged QT, PR, and QRS interval), which may require caution in patients receiving dolasetron.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal 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.

Interactions with 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.

• Apomorphine


• Bepridil


• Cisapride


• Dronedarone


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• 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


• Ajmaline


• Alfuzosin


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Bretylium


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Doxepin


• Droperidol


• Enflurane


• Erythromycin


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Lapatinib


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirmenol


• Posaconazole


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Risperidone


• Salmeterol


• Saquinavir


• Sematilide


• Sertindole


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Zolmitriptan


• Zotepine

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or 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:

• Bradycardia (slow heartbeat) or


• Congestive heart failure or


• Kidney disease—Patients with these conditions should be monitored with an electrocardiogram (ECG) while using this medicine.

• Heart block, without a pacemaker or


• Heart rhythm problems (e.g., congenital long QT syndrome)—Should not be used in patients with these conditions.

• Heart disease or


• Heart rhythm problems (e.g., atrial fibrillation, prolonged QT, PR, and QRS interval) or


• Sick sinus syndrome (type of abnormal heart rhythm)—Use with caution. May increase risk for more serious heart rhythm problems (such as torsade de pointes) and ECG monitoring is recommended.

Proper Use of Anzemet

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.

If your child cannot swallow the tablets, the injection solution mixed with apple or apple-grape juice may be given. The mixed medicine may be stored up to 2 hours at room temperature before use.

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 form (tablets):
  
  • For prevention of nausea and vomiting after treatment with cancer medicines:
    
    • Adults—100 milligrams (mg) given within 1 hour before starting cancer treatment.
    
    
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.8 milligrams (mg) per kilogram (kg) of body weight given within 1 hour before starting cancer treatment. However, the dose is usually not more than 100 mg.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For prevention of nausea and vomiting after surgery:
    
    • Adults—100 milligrams (mg) given within 2 hours before surgery.
    
    
    • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.2 milligrams (mg) per kilogram (kg) of body weight given within 2 hours before surgery. However, the dose is usually not more than 100 mg.
    
    
    • Children younger than 2 years of age—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

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

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.

Precautions While Using Anzemet

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

This medicine can cause changes in heart rhythms, such as conditions called QT, PR, and QRS prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Do not stop taking this medicine without checking first with your doctor. Your doctor may gradually reduce the amount you are using before stopping completely.

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.

Anzemet 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

• Chest pain or discomfort


• lightheadedness, dizziness, or fainting


• shortness of breath


• slow or irregular heartbeat


• unusual tiredness or weakness

Less common

• Chills


• decrease in the amount of urine


• fast, pounding, or irregular heartbeat or pulse


• fever

Less common or rare

• Agitation


• black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• blurred vision


• burning while urinating


• changes in skin color


• coma


• confusion


• cough


• depression


• difficult or labored breathing


• difficult or painful urination


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• frequent urination


• headache


• hives or welts


• hostility


• increased volume of pale, dilute urine


• irritability


• itching of the skin


• lethargy


• muscle twitching


• nausea


• noisy breathing


• numbness and tingling of the face, fingers, or toes


• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion


• pain, tenderness, or swelling of the foot or leg


• pale skin


• pale, bluish-colored, or cold hands or feet


• pinpoint red or purple spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• redness of the skin


• seizures


• skin rash


• stupor


• sweating


• swelling of the face, ankles, or hands


• tightness in the chest


• tingling of the hands or feet


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual weight gain or loss


• weak or absent pulses in the legs


• wheezing

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

• Diarrhea

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• pain


• stomach discomfort, upset, or pain

Less common or rare

• Abnormal dreams


• agitation


• bad, unusual, or unpleasant (after) taste


• bloating


• bloody nose


• change in color vision


• change in taste


• changes in vision


• continuing ringing or buzzing or other unexplained noise in the ears


• darkened urine


• difficulty having a bowel movement (stool)


• difficulty seeing at night


• difficulty with moving


• feeling of constant movement of self or surroundings


• feeling of unreality


• feeling of warmth


• hearing loss


• increased sensitivity of the eyes to sunlight


• increased sweating


• joint pain


• loss of appetite


• muscle aching or cramping


• muscle pain or stiffness


• pain or burning sensation at the injection site


• pains in the stomach, side, or abdomen, possibly radiating to the back


• redness of the face, neck, arms, and occasionally, upper chest


• sensation of spinning


• sense of detachment from self or body


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• swollen joints


• trembling or shaking of the hands or feet


• unsteadiness, trembling, or other problems with muscle control or coordination


• vomiting


• weight loss


• yellow eyes or 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.

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