DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Mucomyst (Acetylcysteine Inhalation) - Summary

 
 



MUCOMYST SUMMARY

MUCOMYST®
(acetylcysteine solution, USP)

MUCOMYST brand of acetylcysteine is for inhalation (mucolytic agent) or oral administration (acetaminophen antidote), and available as sterile, unpreserved solutions (not for injection). The solutions contain 20% (MUCOMYST-20) or 10% (MUCOMYST-10) acetylcysteine, with edetate disodium in purified water. Sodium hydroxide is added to adjust pH to 7. Acetylcysteine is the N-acetyl derivative of the naturally-occurring amino acid, cysteine.

MUCOMYST is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:

Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)

Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)

Pulmonary complications of cystic fibrosis

Tracheostomy care

Pulmonary complications associated with surgery

Use during anesthesia

Post-traumatic chest conditions

Atelectasis due to mucous obstruction

Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)

Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion.


See all Mucomyst indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Mucomyst (Acetylcysteine Inhalation)

The Effects of N-Acetylcysteine and Deferoxamine on Plasma Cytokine and Oxidative Damage Parameters in Critically Ill Patients With Prolonged Hypotension: A Randomized Controlled Trial. [2011.11.01]
Reactive oxygen species and inflammation have been implicated in renal tubule cell injury. However, there is some controversy concerning whether antioxidants might attenuate oxidative damage and inflammation in humans after hypotension in the setting of critical illness... NAC plus DFX administration was able to decrease plasma markers of oxidative damage and creatinine levels at hospital discharge.

Effect of N-acetylcysteine on cardiac injury and oxidative stress after abdominal aortic aneurysm repair: A randomized controlled trial. [2011.09]
BACKGROUND: Several studies have reported that the antioxidant properties of N-acetylcysteine (NAC) can provide cardiac protection through scavenging of free radicals. The present study was aimed to assess the efficacy of NAC for cardiac protection in patients undergoing elective abdominal aortic aneurysm (AAA) repair... CONCLUSION: NAC infusion provided cardiac protection through scavenging of oxygen free radicals. (c) 2011 The Authors Acta Anaesthesiologica Scandinavica (c) 2011 The Acta Anaesthesiologica Scandinavica Foundation.

Qualitative methods in early-phase drug trials: broadening the scope of data and methods from an RCT of N-acetylcysteine in schizophrenia. [2011.07]
CONCLUSIONS: The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research. TRIAL REGISTRATION: www.anzctr.org.au Identifier: ACTRN12605000363684. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

A randomized trial of intravenous N-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes. [2011.05.03]
Background: Pharmacokinetic data suggests that the intravenous form of n-acetylcysteine (NAC) may be more effective than the oral formulation in preventing contrast induced nephropathy (CIN). NAC owing to its anti-oxidant properties might be beneficial for patients with acute coronary syndromes (ACS) who are at increased risk for CIN...

Effect of N-acetylcysteine treatment on the expression of leukocyte surface markers after burn injury. [2011.05]
Oxidative stress and inflammatory processes generate edema in burns.NAC treatment is associated with a less pronounced inflammation reflected in lower CD marker expression and vasopressor requirement.

more studies >>

Clinical Trials Related to Mucomyst (Acetylcysteine Inhalation)

Use of Mucomyst to Ameliorate Oxidant Stress in Diabetics With Proteinuria [Completed]
The study will look at the effect of 30 days of treatment of 15 diabetics with proteinuria with N-acetylcysteine ( Mucomyst ) at a dose of 1 gm twice a day by mouth. The primary outcome that will be measured is change in the oxidant stress as measurable by changes in the serum level of isoprostane, Glutathione peroxidase, aconitase and Total oxidant stress. Secondary outcomes measured will be changes in proteinuria and kidney function as measured by spot urine pr/cr and estimated GFR by MDRD formula.

Mucomyst for Hepatitis C [Suspended]
The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the changes in oxidant stress as measured by different oxidant stress markers level in sera. Secondary outcomes of interest will be changes in viral load of hep C and changes in liver function

Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection [Recruiting]
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.

Methylprednisolone N Acetylcysteine in Hepatic Resections [Recruiting]
This is a prospective double-blind randomized phase II clinical trial, with two groups of intervention (one with administration of N-acetylcysteine and the other with administration of methylprednisolone), and one group of placebo. The purpose of this study is to investigate the role of N-acetylcysteine and Methylprednisolone in the modulation of warm ischemia of the liver during hepatic resection. In fact to avoid massive blood loss in liver surgery, continuous or intermittent vascular clamping of the hepatic hilum ('Pringle maneuver') is generally used with good results. However, as a consequence, ischemia and subsequent reperfusion result in complex metabolic, immunological, and microvascular changes, which together might contribute to hepatocellular damage and dysfunction. This phenomenon, known as ischemia-reperfusion (IR) injury of the liver, is a complex multi-path process leading to the activation of some inflammatory pathways. Any patient candidate to liver resection will be enrolled in the study based on the aforementioned criteria. The primary objective of the study is to assess the real efficacy of Methylprednisolone and N-acetylcysteine in reducing the secondary damage from ischemia reperfusion injury in liver resection and in reducing inflammatory response. Secondary objective of the study is whether the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative liver failure, improvement of postoperative liver function, and reduction of blood components transfusions. The randomization will be done the day before the operation. The drugs will be prepared in a blind fashion by the hospital pharmacy. The hospital pharmacy will provide to each patient a drip to make bolus of about an hour before the start of the liver resection and a syringe pump for an infusion of approximately 6 hours. If the patient is enrolled and randomized in the placebo arm, he/she will receive 250 ml of glucose 5% plus the infusion of 100 ml of glucose 5% If the patient is randomized in the Methylprednisolone arm, he/she will receive a dose of 500 mg in 250 ml of glucose 5% plus 100 mg of glucose 5%. If the patient is randomized in the N-acetylcysteine arm, he/she will receive a dose of 150 mg/kg in 250 ml of glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml glucose 5%. Systematic sampling of liver function tests will be done the day before the operation, at the end of the operation, as well as in postoperative day 1, 3, 5 and 7.

Mechanisms for the Effect of Acetylcysteine on Renal Function After Exposure to Radiographic Contrast Material [Recruiting]
Millions of people receive radiographic contrast material for investigations like CT and coronary angiography. While considered safe in healthy patients, it can cause acute renal impairment. This is termed radiocontrast-induced nephropathy (RCIN) and is generally defined as an increase in serum creatinine over baseline of more than 25% or 0. 5 mg/dL (44. 2 ╬╝mol/l) within 48 hrs. RCIN occurs in less than 2% of patients with normal renal function but is more common in patients with pre-existing renal damage.

The pathophysiology of RCIN is unclear. Possible mechanisms involve 1) reduced renal blood flow leading to acute tubular necrosis and 2) direct renal tubular injury by oxygen free radicals. Current prevention strategies focus on increasing renal blood flow and reducing oxidative stress. Patients at risk of RCIN currently receive fluids, a low dose of contrast, and variable and unproven doses of acetylcysteine.

The evidence for acetylcysteine administration is unclear. A RCIN consensus working group reported in the American Journal of Cardiology in September 2006 that "N-acetylcysteine is not consistently effective in reducing the risk for contrast-induced nephropathy". The perception of a benefit from acetylcysteine administration that is unproven has disadvantages as some clinicians report giving larger amounts of radio-contrast to patients who have received acetylcysteine since they believe that it prevents RCIN. There is a need to determine how acetylcysteine might prevent RCIN and to identify the appropriate dose and route of administration.

Since acetylcysteine is a vasodilator as well as an antioxidant, it may work in two distinct ways, by preventing reduction in renal blood flow (RBF) or contrast-induced oxidative damage. Previous studies have used changes in serum creatinine. In addition to being an insensitive marker of altered renal function, if contrast causes renal vasoconstriction and acetylcysteine vasodilatation, changes in serum creatinine will not be the ideal marker of effect. Finally the optimum dose and route of acetylcysteine administration is unclear, as illustrated by studies using a variety of doses and routes.

We propose to study the mechanism of effects of acetylcysteine on healthy and diseased kidneys, both unstressed and stressed by radiocontrast administration. We hypothesise that acetylcysteine may exert a renoprotective effect in RCIN by a renal vasodilatation and/or antioxidant mechanism.

more trials >>

Reports of Suspected Mucomyst (Acetylcysteine Inhalation) Side Effects

Foetal Growth Restriction (7)Rhabdomyolysis (3)Foetal Exposure During Pregnancy (3)Foetal Death (3)Maternal Exposure During Pregnancy (3)Maternal Exposure Timing Unspecified (3)Haemorrhage (2)Premature Baby (2)Premature Delivery (2)Shock Haemorrhagic (1)more >>


Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014