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.
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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.
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 μmol/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.
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 >>
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Page last updated: 2011-12-09
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