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ANZEMET- dolasetron mesylate tablet, film coated


  1. Patient Information
  2. Patients Should Be Informed That The Chances Of Developing Serious Cardiac Arrhythmias Such As Qt Prolongation And Torsade De Pointes Or Heart Block Are Higher In The Following People:
  3. Manufactured For And Distributed By:

Patient Information 

Patients should be informed that ANZEMET may cause serious cardiac arrhythmias such as QT prolongation or heart block. Patients should be instructed to tell their health care provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Patients Should Be Informed That The Chances Of Developing Serious Cardiac Arrhythmias Such As Qt Prolongation And Torsade De Pointes Or Heart Block Are Higher In The Following People: 

  • Patients with a personal or family history of abnormal heart rhythms, such as congenital long QT syndrome
  • Patients with a personal history of sick sinus syndrome, atrial fibrillation with slow ventricular response or myocardial ischemia
  • Patients who take medications that may prolong the PR interval, such as certain antihypertensives or medications that may prolong the QRS interval, such as antiarrythmic medications
  • Patients who take medications, such as diuretics, which may cause electrolyte abnormalities
  • Patients with hypokalemia or hypomagnesemia. Some types of chemotherapy cause hypokalemia and hypomagnesemia
  • Elderly patients and renally impaired patients

ANZEMET should be avoided in these patients, since they may be more at risk for cardiac arrhythmias such as QT prolongation and Torsade de Pointes.

Advise patients of the possibility of serotonin syndrome with concomitant use of Anzemet and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.

Prescribing Information as of June 2018

Manufactured For And Distributed By: 

Validus Pharmaceuticals LLC

119 Cherry Hill Road, Suite 110
Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438 (1-866-9VALIDUS)

Product of India

2018 Validus Pharmaceuticals LLC

60035-03 June 2018



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