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Acetylcysteine (N-Acetylcysteine) - Adult/Pediatric - Emergency Department/Inpatient

Acetylcysteine (N-Acetylcysteine) - Adult/Pediatric - Emergency Department/Inpatient - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Medications


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Acetylcysteine (N-acetylcysteine) –
Adult/Pediatric – Emergency
Department/Inpatient
Clinical Practice Guideline
Table of Contents
EXECUTIVE SUMMARY ................................................................................................ 3
SCOPE ........................................................................................................................... 4
DEFINITIONS ................................................................................................................. 5
INTRODUCTION ............................................................................................................. 6
RECOMMENDATIONS ................................................................................................... 7
TABLE 1. N-ACETYLCYSTEINE DOSING FOR CONFIRMED ACETAMINOPHEN
OVERDOSE, NAALF, OR ALCOHOL-INDUCED LIVER FAILURE ............................. 10
UW HEALTH IMPLEMENTATION ................................................................................ 11
IMPLEMENTATION PLAN ........................................................................................... 11
REFERENCES .............................................................................................................. 12
CPG Contact for Content and Changes:
Name: Philip Trapskin, PharmD, BCPS; Manager, Drug Policy Program
Phone Number: 608-265-0341
Email Address: PTrapskin@uwhealth.org
Note: Active Table of Contents
Click to follow link
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Guideline Update Authors:
Timothy Hinkley, PharmD
Joshua Vanderloo, PharmD

Coordinating Team Members:
Joshua Vanderloo, PharmD, Drug Policy Program

Review Individuals/Bodies:
Michael Lucey, MD; Joshua Ross, MD; Teresa Darcy, MD; Jeff Fish, PharmD;
Julie Cable, PharmD; David Hager, PharmD; Philip Trapskin, PharmD

Committee Approvals/Dates:
Lab Committee February 2015
MUE Subcommittee April 2015
P&T Committee October 2012; June 2015

Release Date: November 2016

Next Review Date: June 2018
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Executive Summary
Guideline Overview
This document is intended to guide the use of N-acetylcysteine for the treatment of confirmed
acetaminophen overdoses, non-acetaminophen acute liver failure, and alcohol-induced liver
failure.

Target Population
Adult and pediatric patients receiving N-acetylcysteine.

Key Practice Recommendations
Intravenous and oral dosing of N-acetylcysteine for the treatment of confirmed acetaminophen
overdoses, non-acetaminophen acute liver failure, and alcohol-induced liver failure.


Companion Documents
ED/IP ± Acetylcysteine Administration ± Adult ± Supplemental Order Set [3528]

Pertinent UWHC Policies & Procedures
UWHC Prevention of Contrast-Induced Nephropathy ± Adult ± Inpatient/Ambulatory ± Clinical
Practice Guideline








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Scope

Disease/Condition(s):
- Treatment of confirmed acetaminophen overdose
- Non-acetaminophen acute liver failure (NAALF) management in adult patients
- Alcohol-induced liver failure

Clinical Specialty/Intended Users:
- Medicine
- Hepatology
- Nephrology
- Respiratory/Pulmonary
- Pediatrics

CPG objective:
To guide the use of N-acetylcysteine for appropriate indications and dosing.

Target Population:
- Adult and pediatric with acetaminophen overdose
- Adult patients with non-acetaminophen acute liver failure
- Adult patients with alcohol-induced liver failure
- Adult and pediatric patients at risk for contrast induced nephropathy

Major Outcomes Considered:
- Survival to discharge
- Transplant-free survival
- Improvement in coma grade score

Guideline Metrics:
- Normalization of LFTs to baseline (AST, ALT, Bilirubin, INR)

Methodology
Methods Used to Collect/Select the Evidence:
An extensive evidence review through October 2014. Searches were extended to studies,
reviews, and other evidence that were conducted in human subjects, published in English, and
accessible via PubMed, EMBASE, Cochrane,
Agency for Healthcare Research and Quality Reports, and other selected databases relevant to
this guideline.

Methods Used to Assess the Quality and Strength of the
Evidence:
A modified Grading of Recommendations Assessment, Development and Evaluation (GRADE)
developed by the American Heart Association and American College of Cardiology (Figure 1) was
used to assess the quality and strength of the evidence and recommendations.1




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Figure 1. Grades of Recommendations and Levels of Evidence


Definitions
ξ NAALF: Non-acetaminophen acute liver failure2,3
o includes liver failure etiologies of hepatitis B; other non-acetaminophen, drug-
induced hepatotoxicity; and autoimmune hepatitis
o excludes alcohol-induced liver failure
ξ N-acetylcysteine: N-Ac or acetylcysteine
ξ Rumack-Matthew Nomogram (Figure 2); used for interpretation of acetaminophen
concentrations in association with potential acetaminophen overdose4,5
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Figure 2. Rumack-Matthew Nomogram

Introduction
Acetylcysteine (N-Acetylcysteine or N-Ac) is a derivative of cysteine. It has mucolytic activity that
is exerted through physical disruption of chemical bonds in mucous that results in decreased
mucous viscosity. N-acetylcysteine also acts as an antidote to acetaminophen toxicity by
enhancing glutathione stores, providing a glutathione substitute, and enhancing disposition by
nontoxic sulfate conjugation. N-acetylcysteine has also been implicated in free radical scavenging
antioxidant activity and subsequent cytoprotection.6 These mechanisms of action have led to
FDA-labeled indications for N-Ac as an acetaminophen overdose antidote and as a mucolytic
agent.6

The diverse mechanisms of action demonstrated by N-acetylcysteine, particularly its antioxidant
effects, have resulted in substantive off-label use of this agent for numerous clinical health states.
The most common off-label uses include: NAALF, alcohol-induced liver failure, hemorrhagic
cystitis, hepatorenal syndrome, radiographic contrast agent nephropathy prophylaxis, and
multiple organ failure prophylaxis.

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Recommendations
1. Appropriate indications for use6,7:
1.1. Treatment of confirmed acetaminophen overdose. (I, A)
1.2. Treatment of conditions that involve significant, abnormal, viscid mucus secretions are
generally managed with nebulized hypertonic saline. In pediatric neuromuscular
disorders with atelectasis due to mucus obstruction N-Ac may be a more appropriate
option than hypertonic saline.8 (I, A)
1.3. NAALF management in adult patients (IIa, B)2,3,9,10
1.4. Alcohol-induced liver failure. (IIa, B)11,12
1.5. Contrast Induced Nephropathy (CIN): refer to UWHC Prevention of Contrast-Induced
Nephropathy ± Adult ± Inpatient/Ambulatory ± Clinical Practice Guideline

2. The following indications have insufficient evidence to support their use (IIb, C)6,7
2.1. Acute renal failure, in patients with chronic renal insufficiency undergoing cardiac
surgery; Prophylaxis
2.2. Acute respiratory distress syndrome
2.3. Administration of anesthesia for procedures
2.4. Bezoar
2.5. Blepharitis
2.6. Cancer
2.7. Cystinosis
2.8. Treatment and prophylaxis of cytotoxicity
2.9. Drug allergies
2.10. Drug tolerance to nitrates
2.11. Prophylaxis of hemorrhagic cystitis
2.12. Hepatic ischemia-reperfusion injury13
2.13. Hepatorenal syndrome
2.14. HIV infection
2.15. Lamellar ichthyosis
2.16. Malaria
2.17. Meconium ileus
2.18. Prophylaxis of multiple organ failure
2.19. Mucolysis associated with occlusion of the ureter
2.20. Otitis media
2.21. Respiratory tract infection
2.22. 6MRJUHQ¶V�V\QGURPH
2.23. Unverricht-Lundborg syndrome

3. Dosing for Recommended Indications
3.1. General recommendations
3.1.1. For the management of acetaminophen overdose, N-acetylcysteine should be
dosed on actual weight up to a maximum of 100 kg for IV administration6 (I, A)
and it is reasonable to dose up to a maximum of 110 kg for oral administration.
(IIa, C)
3.1.2. For other indications, it is reasonable to dose on actual weight up to a maximum
of 100 kg for IV administration and up to a maximum of 110 kg for oral
administration. (IIa, C)
3.1.3. It is reasonable to use enteral N-acetylcysteine regimens preferentially over
intravenous regimens unless a patient is unable to tolerate an enteral regimen.
(IIa, C)

3.2. Treatment of confirmed acetaminophen overdose6,14
3.2.1. N-acetylcysteine should be used in the management of acetaminophen overdose
(I, A)
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3.2.2. In patients with confirmed acetaminophen overdose, no further acetaminophen
should be ordered upon admission (I, A)
3.2.3. An acetaminophen concentration should be obtained four hours or greater after
acetaminophen overdose ingestion. This acetaminophen concentration should be
interpreted according to the Rumack-Matthew nomogram (See Figure 2). If the
measured acetaminophen concentration falls on or above the solid line (the FDA
25% safety line), then the concentration is considered toxic and N-acetylcysteine
treatment is warranted. (I, A)
3.2.3.1. Administration should be initiated within 8 hours of ingestion or as soon
as possible after ingestion (I, A)
3.2.3.2. The Rumack-Matthew nomogram should not be applied to patients with
evidence of hepatotoxicity, multiple acetaminophen ingestions (i.e. not a
single ingestion event), or patients with an uncertain time of
acetaminophen ingestion (I, A)
3.2.4. See Table 1 for dosing recommendations.
3.2.5. The oral protocol is as effective as the intravenous one.15,16 Therefore, oral
administration is preferable as it is less invasive and has a lower potential for
anaphylaxis than does the intravenous regimen. (I, A)
3.2.5.1. Shorter courses of oral N-acetylcysteine lasting at least 20 hours may be
considered in the setting repeat acetaminophen concentrations below 10
mcg/mL and no increase in ALT/AST or INR17-20 (IIb, B)
3.2.6. Therapy should be guided by patient condition, resolution of transaminase
elevation, and completion of acetaminophen metabolism.21 (IIa, B)
3.2.7. Patients should have serial acetaminophen levels and LFTs measured before
completion of N-acetylcysteine.22 (IIa, B)
3.2.7.1. The first repeat acetaminophen concentration should be drawn 4-6 hours
after the baseline.14 (IIa,C)
3.2.8. Periodic acetaminophen concentrations should be drawn while N-acetylcysteine is
being continued with a goal of decreasing the acetaminophen concentration below
10 mcg/mL. (IIb, C)
3.2.9. N-acetylcysteine should be continued if acetaminophen levels remain greater than
10 mcg/mL or if the aminotransferases (AST, ALT) remain elevated.22,23 (IIa, A)
3.2.9.1. Maintenance treatment courses may be extended beyond 17 doses or
16 hours for oral or intravenous N-acetylcysteine therapy, respectively, if
clinically warranted, especially in patients with liver injury.24 (IIa, B)
3.2.9.2. Status should be reevaluated 12 hours after initiation of continuation of
N-acetylcysteine.22 (IIa, A)
3.2.9.3. With extended courses of N-acetylcysteine, therapeutic endpoints to
monitor include INR normalization, encephalopathy resolution, and
decreasing AST (to a level at least below 1000 units/L).21(IIa, B)
3.2.10. N-acetylcysteine treatment discontinuation may be considered when a single
acetaminophen concentration is below 10 mcg/mL and AST has decreased to
fewer than 1000 units/mL or may be discontinued at the discretion of the
physician.14,19 (IIb, C)
3.2.10.1. Drawing no further acetaminophen concentrations beyond thirty-six
hours may be reasonable.14,19 (IIb, B)
3.2.10.2. ALT and total bilirubin, if elevated in the setting of acetaminophen
overdose, will resolve more slowly in comparison to AST.
3.2.10.3. INR may be considered to evaluate liver injury (IIb, C)

3.3. NAALF management
3.3.1. N-acetylcysteine use is reasonable for use in adults for NAALF management.3,25
(IIa, B)
3.3.2. N-acetylcysteine use may be considered in pediatric patients for NAALF
management26,27 (IIb, B)
3.3.3. See Table 1 for dosing recommendations.
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3.3.4. N-acetylcysteine treatment discontinuation may be considered AST has fallen
below the threshold of five times the upper limit of normal or may be discontinued
at the discretion of the physician. (IIb, C)

3.4. Alcohol-induced liver failure12
3.4.1. N-acetylcysteine use is reasonable for alcohol-induced liver failure management.
(intravenous: IIa, B; enteral: IIb, C)
3.4.2. See Table 1 for dosing recommendations.
3.4.3. N-acetylcysteine discontinuation may be considered at the discretion of the
physician or if there is no improvement of total bilirubin at day seven of
treatment.(IIb, C)

3.5. Therapeutic use as a mucolytic6 (I, A)
3.5.1. Nebulize via face mask, mouth piece or into a tracheostomy
3.5.2. Use 1-10 mL of 20% N-acetylcysteine solution every one to six hours. Frequency
and volume of medication administration will vary within this range depending on
health condition or surgical procedure necessitating mucolytic therapy.
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Table 1. N-acetylcysteine dosing for confirmed acetaminophen overdose, NAALF, or alcohol-induced liver failureA
Adult Pediatric
Confirmed
acetaminophen
overdose
Oral Loading DoseB 140 mg/kg 140 mg/kg
Oral Maintenance DoseB Following loading dose, 70 mg/kg every 4 hours for 17 doses Following loading dose, 70 mg/kg every 4 hours
for 17 doses

Intravenous Loading
DoseC 150 mg/kg over 60 minutes 150 mg/kg over 60 minutes
Intravenous
Maintenance DoseC
12.5 mg/kg/hr for 4 hours,
then 6.25 mg/kg/hr
12.5 mg/kg/hr for 4 hours,
then 6.25 mg/kg/hr
Adult
NAALF
Oral Loading DoseB 140 mg/kg
Oral Maintenance DoseB Following loading dose, 70 mg/kg every 4 hours for 17 doses

Intravenous Loading
DoseC 150 mg/kg over 60 minutes
Intravenous
Maintenance DoseC
12.5 mg/kg/hr for 4 hours,
then 6.25 mg/kg/hr for 67 hours
Adult
Alcohol-induced
liver failure
Oral Loading DoseB 140 mg/kg
Oral Maintenance DoseB Following loading dose, 70 mg/kg every 4 hours for 17 doses

Intravenous Loading
DoseC 150 mg/kg over 60 minutes
Intravenous
Maintenance DoseC
1) Day 1: 12.5 mg/kg/hr for 4 hours, then 6.25 mg/kg/hr for 16 hours
2) Days 2-5: 4.17 mg/kg/hr for 4 days
A See text for specific recommendations regarding enteral and parenteral administration; enteral is acceptable for any patient who may tolerate it
B
Use actual body weight up to a maximum of 110 kg
C
Use actual body weight up to a maximum of 100 kg
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4. N-acetylcysteine monitoring for recommended indications6,14
4.1. General (IIa, B)
4.1.1. Laboratory
4.1.1.1. Evaluate liver function (AST, ALT, bilirubin, PT/INR), renal function (creatinine, BUN),
blood glucose, hemoglobin, hematocrit, and electrolytes prior to initiating N-
acetylcysteine and daily during continuation N-acetylcysteine therapy
4.1.2. Physical findings and symptom assessment
4.1.2.1. Mucolytic agent: mucous viscosity, respirations
4.1.2.2. Hepatic indications: encephalopathy grade
4.1.3. Anaphylactoid reaction assessment: assessment for the emergence of rash, hypotension,
wheezing, and shortness of breath shortly after intravenous infusion initiation
4.1.3.1. Anaphylactic reactions should be managed with antihistamines and epinephrine, as
necessary

UW Health Implementation
Potential Benefits/Harms:
The predominant benefit with guideline implementation will be standardization of can-acetylcysteine use to
promote safety and adherence to evidence-based use in managing patients. Additionally, when utilized for
acetaminophen overdoses, avoidance of fulminant liver failure, possible liver transplant or death may be
avoided.

Implementation Plan
A. The restriction of N-acetylcysteine use to appropriate, evidence-based indications will be
operationalized by linking the guideline to the medication orders
B. An N-acetylcysteine order set is available to assist practitioners in ordering N-acetylcysteine for various
indications: ED/IP ± Acetylcysteine Administration ± Adult ± Supplemental Order Set [3528]
C. Decentralized clinical pharmacists will be educated about this guideline through pharmacy team
meetings.

Disclaimer
CPGs are described to assist clinicians by providing a framework for the evaluation and treatment of patients.
This Clinical Practice Guideline outlines the preferred approach for most patients. It is not intended to replace a
FOLQLFLDQ¶V�MXGJPHQW�RU�WR�HVWDEOLVK�D�SURWRFRO�IRU�DOO�SDWLents. It is understood that some patients will not fit the
clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate
approach to a problem.


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