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Proamatine (Midodrine Hydrochloride) - Summary

 
 



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.

 

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.


See all Proamatine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Proamatine (Midodrine)

Hypoxia, Hypotension 'Deadly Combo' in TBI
Source: Medscape Critical Care Headlines [2014.11.16]
A new study shows the combination of hypoxia and hypotension has a synergistic and "profoundly" negative effect on mortality in the setting of traumatic brain injury.
Medscape Medical News

Low Blood Pressure (Hypotension) Pictures Slideshow
Source: MedicineNet Abdominal Aortic Aneurysm Specialty [2014.08.13]
Title: Low Blood Pressure (Hypotension) Pictures Slideshow
Category: Slideshows
Created: 7/29/2008 12:00:00 AM
Last Editorial Review: 8/13/2014 12:00:00 AM

Low Blood Pressure (Hypotension)
Source: MedicineNet Abdominal Aortic Aneurysm Specialty [2014.07.14]
Title: Low Blood Pressure (Hypotension)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/14/2014 12:00:00 AM

Orthostatic Hypotension
Source: MedicineNet Addison Disease Specialty [2014.01.08]
Title: Orthostatic Hypotension
Category: Diseases and Conditions
Created: 6/11/2009 12:00:00 AM
Last Editorial Review: 1/8/2014 12:00:00 AM

Aspirin, Clonidine Fail to Halt Nephropathy After Surgery
Source: Medscape Nephrology Headlines [2014.11.18]
The perioperative use of aspirin or clonidine does not prevent kidney injury, a substudy of POISE-2 suggests, and can lead to major bleeding and hypotension.
Medscape Medical News

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Published Studies Related to Proamatine (Midodrine)

Midodrine in patients with cirrhosis and refractory or recurrent ascites: A randomized pilot study. [2011.07.13]
BACKGROUND & AIMS: Splanchnic arterial vasodilatation plays an important role in cirrhotic ascites. The aim of this study was to evaluate the effects of long term administration of midodrine on systemic hemodynamics, renal function, and control of ascites in patients with cirrhosis and refractory or recurrent ascites... CONCLUSIONS: The results of this randomized pilot study suggest that midodrine plus standard medical therapy improves the systemic hemodynamics without any renal or hepatic dysfunction in these patients and is superior to standard medical therapy alone for the control of ascites. Copyright (c) 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

The effects of midodrine on the natriuretic response to furosemide in cirrhotics with ascites. [2010.10]
BACKGROUND: Resistance to loop diuretics is common in patients with ascites. Diminished glomerular filtration rate (GFR) is thought to mediate resistance to loop diuretics. Midodrine, a commonly used alpha-1 agonist, has been shown to improve GFR in non-azotemic patients with cirrhosis. AIM: To conduct a randomized, double-blind, placebo-controlled, cross-over study to test the hypothesis that midodrine significantly increases natriuretic response of IV furosemide in non-azotemic cirrhotics with ascites... CONCLUSIONS: Oral midodrine does not increase the natriuretic response to furosemide in non-azotemic cirrhotic patients with ascites. Orally administered midodrine does not increase natriuretic response to furosemide in non-azotemic cirrhotic patients with ascites. (c) 2010 Blackwell Publishing Ltd.

[Efficacy of midodrine hydrochloride in the treatment of children with vasovagal syncope] [2009.07.28]
OBJECTIVE: To explore the efficacy of midodrine hydrochloride in the treatment of vasovagal syncope (VVS) in children... CONCLUSION: Health education and cresol are conventional therapies for pediatric VVS. The efficacy can be enhanced by supplementing midodrine hydrochloride. Such a regimen is effective and safe in treating pediatric VVS.

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.

more studies >>

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.

Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation [Recruiting]
The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.

Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment [Recruiting]
The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.

more trials >>


Page last updated: 2014-11-18

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