Midodrine

Supine Blood Pressure > 180 mmHg

• Because midodrine 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 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, principally improved ability to carry out activities of daily living, have not been verified.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Not recommended for use in patients with initial supine systolic blood pressure > 180 mmHg
• Monitor supine and sitting blood pressures during therapy

FDA and Industry Communications

• FDA Proposes U.S. Market Withdrawal (Aug/Sep 2010)

Patient Counseling Information

• Midodrine Hydrochloride

• ProAmatine

Package Inserts

Midodrine

Additional Information

• PubMed - Midodrine