Warning:
Because ProAmatine® 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 ProAmatine® 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 ProAmatine®, principally improved ability to carry out activities of daily living, have not been verified.
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PROAMATINE SUMMARY
ProAmatine®
(midodrine hydrochloride)
Tablets
ProAmatine ® (midodrine hydrochloride) forms an active metabolite, desglymidodrine, that is an alpha1-agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure.
ProAmatine ® is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because ProAmatine ® can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on ProAmatine ®'s effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine ®, principally improved abitlity to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of ProAmatine ®. After initiation of treatment, ProAmatine ® should be continued only for patients who report significant symptomatic improvement.
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