Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
Midodrine Hydrochloride Tablets, USP Rx only WARNING: Because midodrine hydrochloride can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to carry out activities of daily living, have not been verified.
United States
Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.