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.

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NEWS HIGHLIGHTS

Published Studies Related to Mucomyst (Acetylcysteine Inhalation)

N-Acetylcysteine as adjunctive treatment in severe malaria: A randomized, double-blinded placebo-controlled clinical trial. [2009.12.26]
OBJECTIVE:: Markers of oxidative stress are reported to be increased in severe malaria. It has been suggested that the antioxidant N-acetylcysteine (NAC) may be beneficial in treatment. We studied the efficacy and safety of parenteral NAC as an adjunct to artesunate treatment of severe falciparum malaria... CONCLUSION:: Systemic oxidative stress is increased in severe malaria. Treatment with NAC had no effect on outcome in patients with severe falciparum malaria in this setting.

Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure. [2009.09]
BACKGROUND & AIMS: N-acetylcysteine (NAC), an antidote for acetaminophen poisoning, might benefit patients with non-acetaminophen-related acute liver failure... CONCLUSIONS: Intravenous NAC improves transplant-free survival in patients with early stage non-acetaminophen-related acute liver failure. Patients with advanced coma grades do not benefit from NAC and typically require emergency liver transplantation.

A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis. [2009.08.12]
OBJECTIVE: We conducted a single-centre, randomised, double-blinded, placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose (700 mg/daily) or high-dose (2800 mg/daily) of NAC... CONCLUSIONS: High-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways.

Effect of N-acetylcysteine on air trapping in COPD: a randomized placebo-controlled study. [2009.08]
BACKGROUND: FEV(1) is used for the classification of disease severity and is a good predictor of COPD mortality. However, it is a poor predictor of clinical symptoms, exercise tolerance, and response to bronchodilators in COPD. Progressive reduction in inspiratory capacity (IC) during exercise reflects dynamic hyperinflation and is a good predictor of decreased exercise ability as well as increased exertional dyspnea. In animal models of COPD, N-acetylcysteine (NAC), an antioxidant/mucous modifier, has been shown to modify small airways, which mainly causes lung hyperinflation. OBJECTIVE: Our goal was to examine the effect of 1,200 mg/d of NAC on lung hyperinflation at rest and after exercise in patients with moderate-to-severe COPD... CONCLUSIONS: NAC treatment of patients with stable, moderate-to-severe COPD has a beneficial effect on physical performance, probably due to a reduction in air trapping. Trial registration: Clinicaltrials.gov Identifier: NCT00476736.

N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. [2009.07]
CONTEXT: Trichotillomania is characterized by repetitive hair pulling that causes noticeable hair loss. Data on the pharmacologic treatment of trichotillomania are limited to conflicting studies of serotonergic medications. N-acetylcysteine, an amino acid, seems to restore the extracellular glutamate concentration in the nucleus accumbens and, therefore, offers promise in the reduction of compulsive behavior. OBJECTIVE: To determine the efficacy and tolerability of N-acetylcysteine in adults with trichotillomania... CONCLUSIONS: This study, the first to our knowledge that examines the efficacy of a glutamatergic agent in the treatment of trichotillomania, found that N-acetylcysteine demonstrated statistically significant reductions in trichotillomania symptoms. No adverse events occurred in the N-acetylcysteine group, and N-acetylcysteine was well tolerated. Pharmacologic modulation of the glutamate system may prove to be useful in the control of a range of compulsive behaviors. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00354770.

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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

N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) [Completed]
The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children.

Optimalization of Nephroprotection Using N-Acetylcysteine [Completed]
The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

A Multi-Center Study of the Safety and Efficacy of N-Acetylcysteine in ALF [Completed]
The present proposal is to expand and continue the double blind, randomized trial of N-acetylcysteine vs. placebo for the treatment of non-acetaminophen ALF, to test the safety and efficacy of a short course (72 hours) of intravenous N-acetylcysteine in patients with acute liver failure for whom no antidote or other specific treatment is available.

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