Proamatine (Midodrine Hydrochloride) - Summary

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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NEWS HIGHLIGHTS

Media Articles Related to Proamatine (Midodrine)

Orthostatic Hypotension
Source: MedicineNet Addison Disease Specialty [2009.06.11]
Title: Orthostatic Hypotension
Category: Diseases and Conditions
Created: 6/11/2009
Last Editorial Review: 6/11/2009

Low Blood Pressure (Hypotension) Photo Slideshow
Source: MedicineNet Addison Disease Specialty [2008.07.30]
Title: Low Blood Pressure (Hypotension) Photo Slideshow
Category: Slideshows
Created: 7/29/2008
Last Editorial Review: 7/30/2008

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Published Studies Related to Proamatine (Midodrine)

Midodrine for the treatment of organic anejaculation but not spinal cord injury: a prospective randomized placebo-controlled double-blind clinical study. [2009.07]
Anejaculation is a rare cause of infertility and adversely affects the general sense of well-being and perception of sexual life satisfaction... Further studies are needed, however, for the evaluation of different treatment regimens in anejaculation therapy.

Midodrine versus albumin in the prevention of paracentesis-induced circulatory dysfunction in cirrhotics: a randomized pilot study. [2008.06]
OBJECTIVES: Intravenous albumin has been used to prevent paracentesis-induced circulatory dysfunction (PICD) in cirrhotics; however, its use is costly and controversial. Splanchnic arterial vasodilatation is primarily responsible for PICD. There are no reports of use of midodrine in the prevention of PICD. In this pilot study, we evaluated midodrine and albumin in the prevention of PICD... CONCLUSIONS: The study suggests that midodrine may be as effective as albumin in preventing PICD in cirrhotics, but at a fraction of the cost, and can be administered orally. Midodrine also resulted in an increase in 24-h urine volume and sodium excretion.

Octreotide/Midodrine therapy significantly improves renal function and 30-day survival in patients with type 1 hepatorenal syndrome. [2007.03]
Type 1 hepatorenal syndrome (HRS) can be a rapidly fatal consequence of liver failure... A randomized, controlled trial is the next important step toward evaluating this treatment modality.

Midodrine hydrochloride and L-threo-3,4-dihydroxy-phenylserine preserve cerebral blood flow in hemodialysis patients with orthostatic hypotension. [2007.02]
Orthostatic hypotension (OH) after hemodialysis (HD) is a serious complication, as it causes various neurological symptoms and even ischemic brain damage. The aim of the present study was to evaluate the effects of antihypotensive agents, midodrine hydrochloride (MID) and L-threo-3,4-dihydroxyphenylserine (L-DOPS), on OH after HD.

Effects of a 7-day treatment with midodrine in non-azotemic cirrhotic patients with and without ascites. [2007.02]
BACKGROUND/AIMS: Splanchnic arterial vasodilatation has been causally related with hyperdynamic circulation and impaired natriuresis in advanced cirrhosis and has also been suggested to be responsible for the subtle sodium retention in pre-ascitic cirrhosis. This study evaluated the effects of a 7-day treatment with the alpha1-adrenergic agonist midodrine in non-azotemic cirrhotic patients with and without ascites... CONCLUSIONS: The administration of midodrine for 7 days improves systemic haemodynamics and sodium excretion in non-azotemic cirrhotic patients without or with ascites. In patients with ascites, but not in those without ascites, these effects are associated with a suppression of the activity of the renin-angiotensin-aldosterone system, suggesting that the increase in natriuresis is related to the improvement in the effective arterial blood volume.

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Clinical Trials Related to Proamatine (Midodrine)

Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.

Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.

Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension [Completed]
The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.

A Phase IV Study in Subjects With Neurogenic Orthostatic Hypotension [Terminated]
We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i. e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease.

The purpose of this clinical study is to further assess the clinical effect of high dose midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down, sitting and standing positions will be measured. Patients will also complete standing time assessments. They will be asked to remain standing without moving until they feel sufficiently lightheaded, or dizzy, or feel faint so that they would feel more comfortable sitting down.

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