Safety

Mytelase (ambenonium chloride) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

November 2014

Summary View

PRECAUTIONS

  • The drug should be used with caution in patients with bradycardia or cardiac conduction disorders

ADVERSE REACTIONS

  • bradycardia and cardiac conduction disorders
     

 

November 2011

Summary View

CONTRAINDICATIONS

  • Mytelase should also not be administered to patients with a known hypersensitivity to ambenonium chloride or any other ingredients of Mytelase

PRECAUTIONS

  • The drug should be used with caution in patients with ...Parkinson’s Disease
Nursing Mothers
  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Mytelase a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug the mother.

ADVERSE REACTIONS

  • nausea, increase in bronchial and lachrymal secretions, and vomiting, and nicotinic effects such as muscle cramps, fasciculation of voluntary muscles, and rarely generalized malaise with anxiety and vertigo
     

Page Last Updated: 12/11/2014
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