Label Changes for:
Mytelase (ambenonium chloride) Tablets
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- The drug should be used with caution in patients with bradycardia or cardiac conduction disorders
- bradycardia and cardiac conduction disorders
- Mytelase should also not be administered to patients with a known hypersensitivity to ambenonium chloride or any other ingredients of Mytelase
- The drug should be used with caution in patients with ...Parkinson’s Disease
- 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.
- 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