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Medihaler-Iso (Isoproterenol Sulfate Inhalation) - Summary

 
 



MEDIHALER-ISO SUMMARY

Medihaler-Iso™
(isoproterenol sulfate)
Inhalation Aerosol

MEDIHALER-ISO (isoproterenol sulfate) is a short-acting sympathomimetic administered by oral inhalation for the treatment of bronchoconstriction. Each metered dose of the aerosol delivers through the oral adapter 0.08 mg isoproterenol sulfate of appropriate particle size (the majority less than 5μ). This drug product also contains dichlorodifluoromethane, dichlorotetrafluoroethane, sorbitan trioleate, and trichloromonofluoromethane.

MEDIHALER-ISO is indicated for the treatment of reversible obstructive airways disease.


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NEWS HIGHLIGHTS

Published Studies Related to Medihaler-Iso (Isoproterenol Inhalation)

Particulate matter inhalation exacerbates cardiopulmonary injury in a rat model of isoproterenol-induced cardiomyopathy. [2010.04]
Ambient particulate matter (PM) exposure is linked to cardiovascular events and death, especially among individuals with heart disease. A model of toxic cardiomyopathy was developed in Spontaneously Hypertensive Heart Failure (SHHF) rats to explore potential mechanisms... The enhanced sensitivity to PM exposure in SHHF rats with ISO-accelerated cardiomyopathy suggests that this model may be useful for elucidating the mechanisms by which PM exposure exacerbates heart disease.

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Clinical Trials Related to Medihaler-Iso (Isoproterenol Inhalation)

Measurement of Bispectral Index and Awareness in Patients Undergoing Electrophysiology Studies With Isoproterenol [Recruiting]
Isoproterenol is used as a cardiac stimulant in electrophysiology studies (EP). Preliminary data suggests that administration of isoproterenol increases the Bispectral index (BIS). BIS is used to monitor neuronal signals under anesthesia. The BIS level is suggested to correspond to the level of consciousness. We hypothesize that isoproterenol increases BIS values because it increases the patient's level of consciousness through its central nervous system (CNS) stimulatory effects. In this study, we will administer increasing doses of isoproterenol to EPS patients. We will measure the BIS levels continuously before and after isoproterenol administration. In addition, we will test the level of awareness of patients by their response to a modified isolated forearm technique.

Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms [Completed]
Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the 2 adrenergic receptor (2AR) modify its pharmacological properties and may alter the response to 2AR agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo.

Internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. Four rings that were prepared from each specimen were allowed to reach equilibrium with physiological Krebs solution prior to precontraction with U46619. Using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean EC50 calculated for each patient.

Isoproterenol Challenge to Detect Arrhythmogenic Right Ventricular Cardiomyopathy [Completed]
This study will examine the usefulness of a new test called an isoproterenol challenge in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) and family members who may have the disease but do not have clear-cut evidence of it. ARVC is a rare condition that runs in families. Heart muscle is replaced with fatty, scar-like tissue, especially in the right ventricle (lower pumping chamber of the heart), and can sometimes extend to the left ventricle (the main pumping chamber). The fat can interfere with the heartbeat, producing

abnormal heart rhythms, such as ventricular tachycardia (VT) - a very fast heartbeat that can

cause sudden death, especially in young people. Isoproterenol is a drug that increases heart rate and heart muscle contractions. In isoproterenol challenge, subjects are given increasing doses of the drug through a catheter (see details below) to try to produce an abnormal heart rhythm.

ARVC is hard to diagnose with current tests. This study will see if isoproterenol challenge provokes VT in patients with the disease and can confirm the diagnosis; if it can detect the disease in family members better than currently available tests; and if it provokes abnormal rhythms in healthy control subjects. In addition, the study will explore the genetics of ARVC and determine whether infection could contribute to its development.

Patients with ARVC, their family members, and normal volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and physical examination, electrocardiogram (EKG), treadmill and bicycle exercise testing, and an echocardiogram (ultrasound test of the heart).

Participants undergo the following tests and procedures:

- Blood tests - Blood is collected to study the genetics of ARVC, to test for evidence of

old infections, and to measure brain natriuretic peptide - a hormone that can increase

with development of heart failure.

- Heart magnetic resonance imaging (MRI). This test looks at heart structure and function.

MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking sounds that occur during the scanning process. At some time during the test, the subject is given a contrast agent called gadolinium through a catheter (thin, flexible tube) in a vein to improve the scan pictures. The scan time varies from 30 to 90 minutes, with most scans lasting 60 minutes. (Control subjects do not undergo MRI.)

- Isoproterenol challenge. Subjects are given increasing doses of isoproterenol through a

catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1 hour. A special EKG records heart rhythm during the test and an echocardiogram records right and left ventricular function.

- QRST surface mapping EKG. This special EKG, done with 64 or 120 leads, maps

abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge. These tests are like a regular EKG, except that more leads are placed on the chest, and on the back as well.

Patients and family members who wish to have follow-up visits may return to the NIH Clinical Center once a year for 5 years for guidance about therapy based on clinical considerations and new information or investigations.

Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas [Recruiting]
The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which are benign fatty tumors.

Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract [Completed]
The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.

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Page last updated: 2010-10-05

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