Pergolide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Black Box Warning
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Cardiac Valvulopathy and Fibrotic Complications
See full prescribing information for complete Boxed Warning.
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 (seeDOSAGE & 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.
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. |
Overview
Pergolide is an antiparkinsonian, autonomic, central nervous system agent, dopamine agonist that is FDA approved for the treatment of Parkinson's disease as an adjunctive treatment with carbidopa/levodopa. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Pergolide FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pergolide in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pergolide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pergolide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pergolide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pergolide in pediatric patients.
Contraindications
There is limited information regarding Pergolide Contraindications in the drug label.
Warnings
|
Cardiac Valvulopathy and Fibrotic Complications
See full prescribing information for complete Boxed Warning.
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 (seeDOSAGE & 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.
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. |
There is limited information regarding Pergolide Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Pergolide Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Pergolide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Pergolide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Pergolide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pergolide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Pergolide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Pergolide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Pergolide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Pergolide in geriatric settings.
Gender
There is no FDA guidance on the use of Pergolide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pergolide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pergolide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pergolide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pergolide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pergolide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Pergolide Administration in the drug label.
Monitoring
There is limited information regarding Pergolide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Pergolide and IV administrations.
Overdosage
There is limited information regarding Pergolide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Pergolide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Pergolide Mechanism of Action in the drug label.
Structure
There is limited information regarding Pergolide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pergolide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Pergolide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Pergolide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Pergolide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Pergolide How Supplied in the drug label.
Storage
There is limited information regarding Pergolide Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Pergolide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Pergolide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Pergolide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Pergolide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.