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Permax (Pergolide Mesylate) - Summary

 
 



WARNING

Cardiac Valvulopathy and Fibrotic Complications

Cardiac Valvulopathy

The use of pergolide has been shown to increase the risk of cardiac valvular disease involving one or more valves.  Some patients have required valve replacement, and deaths have been reported. Cases have been reported after exposures to pergolide ranging from several months to several years.  The histopathology of explanted valves is similar to that of other drug-induced valvulopathies. Precise risk estimates of pergolide-induced cardiac valvular disease are not available.

Specific risk factors predisposing patients to developing cardiac valvular disease with pergolide have not been identified.  Cardiac valvulopathy has been reported with all doses of pergolide; however, available data suggest that the risk may be greater with higher doses.  Doses of pergolide above 5 mg/day are not recommended ( see DOSAGE & ADMINISTRATION ).

Pergolide is not recommended for use in patients with a history of cardiac valvulopathy.

Before initiating treatment with pergolide, all patients should undergo a cardiovascular evaluation, including an echocardiogram, to determine whether valvular disease is present and to provide a baseline for subsequent monitoring.  Although the risk of disease progression in patients with asymptomatic valvular disease is unknown, pergolide ordinarily should not be initiated if valvulopathy is detected at screening.

All patients taking pergolide should undergo periodic echocardiograms to screen for the development of valvulopathy. Patients should also be monitored for signs and symptoms of valvulopathy, including dyspnea, edema, congestive heart failure and new cardiac murmurs. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation, including echocardiogram, has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with cardiac valvular disease. In some cases, signs and/or symptoms of cardiac valvulopathy improved after discontinuation of pergolide.

Fibrotic Complications

Case reports have demonstrated that pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis, pleuritis, and pericardial and/or pleural effusions.  Cases have been reported after exposures to pergolide ranging from about one to several years.  Precise risk estimates of pergolide-induced fibrotic complications are not available.

Specific risk factors predisposing patients to developing fibrotic complications with pergolide have not been identified.  Fibrotic complications have been reported with all therapeutic doses of pergolide.

Pergolide is not recommended for use in patients with a history of fibrotic conditions.

Patients should also be monitored for signs and symptoms of fibrotic complications, including dyspnea, persistent edema, cough, congestive heart failure, new cardiac rub, and/or signs of urinary tract obstruction. If a patient develops these signs or symptoms, consideration should be given to suspending treatment with pergolide until a full diagnostic evaluation has been performed. Pergolide should ordinarily be discontinued if a patient is diagnosed with a specific fibrotic complication. In some cases, signs and/or symptoms of fibrotic complications improved after discontinuation of pergolide.

 

PERMAX SUMMARY

PERMAX®
PERGOLIDE TABLETS, USP

Permax® (Pergolide Tablets, USP) is an ergot derivative dopamine receptor agonist at both D1 and D2 receptor sites.

Permax is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease.


See all Permax indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Permax (Pergolide)

Pergolide treatment of cognitive deficits associated with schizotypal personality disorder: continued evidence of the importance of the dopamine system in the schizophrenia spectrum. [2010.05]
Cognitive deficits observed in schizophrenia are also frequently found in individuals with other schizophrenia spectrum disorders, such as schizotypal personality disorder (SPD)...

Pergolide treatment of cognitive deficits associated with schizotypal personality disorder: continued evidence of the importance of the dopamine system in the schizophrenia spectrum. [2010]
Cognitive deficits observed in schizophrenia are also frequently found in individuals with other schizophrenia spectrum disorders, such as schizotypal personality disorder (SPD)...

Dopamine and cognitive functioning in de novo subjects with Parkinson's disease: effects of pramipexole and pergolide on working memory. [2009.04]
Very few studies have investigated the relationship between dopaminergic therapy and working memory (WM) functioning in Parkinson's disease (PD) patients. The aim of the present study was to explore the effects of pharmacological treatment with pergolide (a D1+D2 receptor agonist) and pramipexole (a D2+D3 receptor agonist) on performance in visual-spatial, visual-object, and verbal WM tasks in PD patients...

Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study. [2006.03]
Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long-term studies, allowing "rescue" therapy with levodopa... The choice remains with the treating physician based on the different efficacy and adverse event profiles.

Nocturnal activity with nighttime pergolide in Parkinson disease: a controlled study using actigraphy. [2005.04.26]
Pergolide is a dopamine agonist that improves Parkinson disease but is associated with dose-dependent sleepiness... Side effects were more frequent in the pergolide group.

more studies >>

Clinical Trials Related to Permax (Pergolide)

Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder [Recruiting]
Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0. 3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo.

Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.

Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide [Active, not recruiting]
The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.

Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia [Suspended]
Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. This double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.

Compassionate Use Study of Pergolide in Patients With Parkinson's Disease [Available]
This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.

Pergolide Treatment for Substance Abusers - 4 [Completed]

more trials >>


Page last updated: 2013-02-10

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