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Dolasetron Mesylate Monohydrate Oral tablet

It is used to prevent nausea and vomiting caused by chemotherapy.

Generic Name: dolasetron

Brand Names: Anzemet

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 12/17/2010] ISSUE: FDA notified healthcare professionals that a contraindication is being added to the prescribing information advising that the injection form of dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that dolasetron injection can increase the risk of developing torsade de pointes, an abnormal heart rhythm, which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. Dolasetron causes a dose-dependant prolongation in the QT, PR, and QRS intervals on an electrocardiogram.

BACKGROUND: FDA previously noted cardiovascular safety concerns which suggested dolasetron could cause QT prolongation. However, limitations of the previous data did not clearly establish the degree to which dolasetron may cause QT prolongation. FDA recommended that the drug sponsor conduct a thorough QT study in adults in order to determine the degree of the prolongation. A pediatric study was not recommended due to the wide variability in heart rate and, thus, QTc interval in the pediatric population. See the Data Summary section of the Drug Safety Communication (DSC) for information that supports this change in the prescribing information.

RECOMMENDATION: Dolasetron should not be used in patients with congenital long-QT syndrome. Hypokalemia and hypomagnesemia should be corrected before administering dolasetron. These electrolytes should be monitored after administration as clinically indicated. Use electrocardiogram monitoring in patients with congestive heart failure, patients with bradycardia, patients with underlying heart disease, the elderly and in patients who are renally impaired who are taking dolasetron. Dolasetron injection may still be used for the prevention and treatment of postoperative nausea and vomiting because the lower doses used are less likely to affect the electrical activity of the heart and result in abnormal heart rhythms.

Dolasetron tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the dolasetron tablet label. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

DOLASETRON (dol A se tron) is used to prevent nausea and vomiting caused by chemotherapy.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • heart disease
  • history of irregular heartbeat
  • kidney disease
  • low levels of magnesium or potassium in the blood
  • an unusual or allergic reaction to dolasetron, granisetron, ondansetron, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not take this medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • arsenic trioxide
  • certain antipsychotics like haloperidol, thioridazine, ziprasodone
  • certain medicines for chemotherapy like daunorubicin, epirubicin, idarubicin
  • certain medicines for irregular heart beat like amiodarone, disopyramide, dofetilide, ibutilide, procainamide, propafenone, quinidine, sotalol
  • certain medicines used for nausea like chlorpromazine, droperidol
  • certain medicines used to treat infections like chloroquine, clarithromycin, erythromycin, pentamidine
  • cisapride
  • dextromethorphan; quinidine
  • dronedarone
  • flecainide
  • methadone

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS
  • atenolol
  • beta-blockers like propranolol
  • calcium channel blockers like diltiazem and verapamil
  • cimetidine
  • digoxin
  • diuretics
  • rifampin

What should I watch for while using this medicine?

Check with your doctor or health care professional right away if you have any sign of an allergic reaction.

Do not drink alcohol while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • chest tightness
  • dizziness
  • fast or irregular heartbeat
  • feeling faint or lightheaded, falls
  • fever and chills
  • swelling of the feet or hands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation or diarrhea
  • headache

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: September 19, 2013
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