"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...
ProAmatine® (midodrine hydrochloride) is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because ProAmatine® (midodrine hydrochloride) 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® (midodrine hydrochloride) '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® (midodrine hydrochloride) , 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® (midodrine hydrochloride) .
After initiation of treatment, ProAmatine® (midodrine hydrochloride) should be continued only for patients who report significant symptomatic improvement.
DOSAGE AND ADMINISTRATION
The recommended dose of ProAmatine® (midodrine hydrochloride) is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before, or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently. Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, ProAmatine® (midodrine hydrochloride) should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, ProAmatine® (midodrine hydrochloride) should be continued only in patients who appear to attain symptomatic improvement during initial treatment.
The supine and standing blood pressure should be monitored regulary, and the administration of ProAmatine® (midodrine hydrochloride) should be stopped if supine blood pressure increases excessively.
Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5-mg doses.
Dosing in children has not been adequately studied.
Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.
ProAmatine® (midodrine hydrochloride) is supplied as 2.5-mg, 5-mg and 10-mg tablets for oral administration. The 2.5-mg tablet is white, round, and biplanar, with a bevelled edge, and is scored on one side with “RPC” above and “2.5” below the score, and “003” on the other side. The 5-mg tablet is orange, round, and biplanar, with a bevelled edge, and is scored on one side with “RPC” above and “5” below the score, and “004” on the other side. The 10-mg is blue, round, and biplanar, with a bevelled edge, and is scored on one side with “RPC” above and “10” below the score, and “007” on the other side.
2.5-milligram Tablets: NDC 54092-003-01 Bottle of 100
5.0-milligram Tablets: NDC 54092-004-01 Bottle of 100
10-milligram Tablets: NDC 54092-007-01 Bottle of 100
Store at 25°C (77°F)
Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
Manufactured for: Shire US Inc., One Riverfront Place, Newport, KY, 41071, USA by NYCOMED Austria GmbH. Rev. 10/03. FDA revision date: 7/22/2004
Last reviewed on RxList: 10/25/2010
This monograph has been modified to include the generic and brand name in many instances.
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