Jane S. Ricciuti, RPh, MS

Disclosures

April 22, 2003

In This Article

Parasympathomimetic Agents

Mytelase
(ambenonium chloride) Capsules

Manufacturer: Sanofi-Synthelabo, Inc

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/26/03)

Precautions: The labeling for Mytelase (ambenonium chloride) has been revised to include a Geriatric subsection to the "Precautions" section:

  • Geriatric Use: Clinical studies of MYTELASE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.'

Mytelase (ambenonium chloride) Capsules Letter

Mytelase (ambenonium chloride) Capsules

Comments

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