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
Patient Counseling Information
Updated January 2018