Acetylcysteine - Drug Information - UpToDate

7/7/2021 Acetylcysteine: Drug information - UpToDate
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Acetylcysteine: Drug information
Copyright 1978-2021 Lexicomp, Inc. All rights reserved.
(For additional information see "Acetylcysteine: Patient drug information" and see "Acetylcysteine: Pediatric drug
information")
For abbreviations and symbols that may be used in Lexicomp ( show table)
Brand Names: US
Acetadote;
Cetylev [DSC]
Brand Names: Canada

Parvolex
Pharmacologic Category
Antidote;
Mucolytic Agent
Dosing: Adult
Acetaminophen overdose: Only the 72-hour oral and 21-hour IV regimens are FDA
approved. Ideally, in patients with acute acetaminophen ingestion, treatment should begin
within 8 hours of ingestion or as soon as possible after ingestion. In patients with a suspected
acute ingestion where the time of ingestion is unknown, the concentration is unobtainable or
uninterpretable within 8 hours of ingestion, the patient presents >8 hours after ingestion, or
there is clinical evidence of toxicity, initiate treatment immediately and re-evaluate the need
for acetylcysteine upon receipt of the results (if applicable). In patients who present following
repeated supratherapeutic ingestion and treatment is deemed appropriate, acetylcysteine
should be initiated immediately. Regardless of the treatment regimen selected, serum
acetaminophen concentrations, liver function, and clinical status should be evaluated during
and prior to the end of the treatment regimen to determine if treatment discontinuation is
appropriate. In patients who continue to experience symptoms of hepatotoxicity or elevated
LFTs at the conclusion of a 72-hour oral or 21-hour IV regimen, extending the treatment
course may be appropriate; however, when and to which patients additional doses should be
administered is unclear. Possible candidates for extended therapy include patients with a
suspected massive overdose, concomitant ingestion of other substances, or patients with
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preexisting liver disease. In patients with persistently elevated acetaminophen concentrations,

persistently elevated LFTs, or an elevated INR, additional acetylcysteine should be
administered. Typically, an additional "third dose" or "third bag" (IV: 100 mg/kg [maximum: 10
g] infused over 16 hours) is administered; however, this dose may be inadequate in some
patients (Rumack 2012). It is critical that there is no delay in the administration of the loading
dose of acetylcysteine and no delays in the administration of bags 2 and 3 (Bailey 2016). A 2-
bag regimen with the same total dose of 300 mg/kg has been used, but is not FDA-approved
(Bateman 2014; Isbister 2016; Wong 2016a). Consultation with a poison control center or
clinical toxicologist is highly recommended to determine optimal patient care.
Note: There is no reason to withhold activated charcoal in a patient with an

acetaminophen overdose. If activated charcoal is administered within 1 to 2 hours
postingestion of acetaminophen, it may provide additional hepatoprotection in patients
requiring NAC treatment for acetaminophen overdose (Spiller 2007).
Oral: (Effervescent tablets [Cetylev]; solution for oral administration): Note: Consultation
with a poison control center or clinical toxicologist is highly recommended when
considering the discontinuation of oral acetylcysteine prior to the conclusion of a full 18-
dose course of therapy.
72-hour regimen: Consists of 18 doses; total dose delivered: 1,330 mg/kg.
Loading dose: 140 mg/kg.
Maintenance dose: 70 mg/kg every 4 hours; repeat dose if emesis occurs within
1 hour of administration.
IV:
21-hour regimen: Consists of 3 doses; total dose delivered: 300 mg/kg.
Loading dose: 150 mg/kg (maximum: 15 g) infused over 1 hour.
Second dose: 50 mg/kg (maximum: 5 g) infused over 4 hours.
Third dose: 100 mg/kg (maximum: 10 g) infused over 16 hours.
Note: The fluid volume should be reduced in patients weighing ≤40 kg.
Alternative recommendations
: Note: Institution-specific regimens may exist; consultation
with a poison control center or clinical toxicologist is highly recommended to determine
optimal patient care. Clinicians should note that experience with these dosing methods is
limited.
"Two bag method" (off-label dosing): Consists of 2 doses; total dose delivered: 300
mg/kg (Wong 2016b):
First dose: 200 mg/kg infused over 4 hours.
Second dose: 100 mg/kg infused over 16 hours.
Note: The "two bag method" has been associated with fewer and milder nonallergic
anaphylactic reactions as compared to the manufacturer's labeled dosing (Wong
2016b).
"Single bag method" (off-label dosing): Total dose delivered 430 mg/kg: Initiate
therapy with 150 mg/kg infused over 1 hour; then decrease the rate to 14 mg/kg/hour and
infuse for an additional 20 hours (Johnson 2011).
Note: Patients weighing >69 kg will require a second bag to complete the dosing
regimen.
Obesity: In patients who weigh >100 kg, the following dosing regimen is recommended:
Oral: Effervescent tablets (Cetylev): Limited information exists regarding the oral dosing
requirements of patients >100 kg.
72-hour regimen: Consists of 18 doses; total dose delivered: 142.5 g.
Loading dose: 15 g.
Maintenance dose: 7.5 g every 4 hours.
IV (Acetadote): 21-hour regimen: Consists of 3 doses; total dose delivered: 30 g.
Loading dose: 15 g infused over 1 hour.
Second dose: 5 g infused over 4 hours.
Third dose: 10 g infused over 16 hours.
Adjuvant therapy in respiratory conditions:
Note: Patients should receive an aerosolized bronchodilator 10 to 15 minutes prior to

dose.
Inhalation, nebulization (face mask, mouth piece, tracheostomy): Acetylcysteine

10% and 20% solution (dilute 20% solution with sodium chloride or sterile water for
inhalation); 10% solution may be used undiluted: 3 to 5 mL of 20% solution or 6 to 10 mL
of 10% solution until nebulized given 3 to 4 times/day; dosing range: 1 to 10 mL of 20%

solution or 2 to 20 mL of 10% solution every 2 to 6 hours.
Inhalation, nebulization (tent, croupette): Dose must be individualized; may require up

to 300 mL solution/treatment.
Direct instillation:
Into tracheostomy: 1 to 2 mL of 10% to 20% solution every 1 to 4 hours.
Through percutaneous intratracheal catheter: 1 to 2 mL of 20% or 2 to 4 mL of 10%

solution every 1 to 4 hours via syringe attached to catheter.
Diagnostic bronchogram: Nebulization or intratracheal: 1 to 2 mL of 20% solution or 2 to 4

mL of 10% solution administered 2 to 3 times prior to procedure.
Dosing: Renal Impairment: Adult

Oral, IV: There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Adult

Oral, IV: There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Pediatric
(For additional information see "Acetylcysteine: Pediatric drug information")
Acetaminophen poisoning:
Note: Only the 72-hour oral and 21-hour IV regimens are FDA approved. Ideally, in
patients with an acute acetaminophen ingestion, treatment should begin within 8 hours of
ingestion or as soon as possible after ingestion. In patients with a suspected acute
ingestion where the time of ingestion is unknown, the serum acetaminophen
concentration is unobtainable or uninterpretable within 8 hours of ingestion, the patient
presents >8 hours after ingestion, or there is clinical evidence of toxicity, initiate treatment
immediately and re-evaluate the need for acetylcysteine upon receipt of the results (if
applicable). In patients who present following repeated supratherapeutic ingestions
(RSTI) and treatment is deemed appropriate, acetylcysteine should be initiated
immediately. Regardless of the treatment regimen selected, serum acetaminophen
concentrations, liver function, and clinical status should be evaluated during and prior to
the end of the treatment regimen to determine if treatment discontinuation is appropriate.
In patients who continue to experience symptoms of hepatotoxicity or elevated liver
function tests at the conclusion of a 72-hour oral or 21-hour IV regimen, extending the
treatment course may be appropriate; however, when and to which patients additional
doses should be administered is unclear. Possible candidates for extended therapy

include patients with a suspected massive overdose, concomitant ingestion of other
substances, or patients with preexisting liver disease. In patients with persistently
elevated acetaminophen concentrations, persistently elevated liver function tests, or an
elevated INR, additional acetylcysteine should be administered. Typically, an additional
"third dose" or "third bag" (IV: 100 mg/kg [maximum dose: 10 g/dose] infused over 16
hours) is administered; however, this dose may be inadequate in some patients (Rumack
2012). It is critical that there is no delay in the administration of the loading dose of
acetylcysteine and no delays in the administration of bags two and three (Bailey 2016). A
two-bag regimen with the same total dose of 300 mg/kg has been used, but is not FDA-
approved (Bateman 2014; Isbister 2016; Wong 2016b). Consultation with a poison
control center or clinical toxicologist is highly recommended to determine optimal patient
care.
Oral: Effervescent tablet (Cetylev) or solution for oral administration (using

injectable/nebulizer formulation):
Note: There is no data for use of the OTC supplement tablets for
acetaminophen poisoning. Dosing below is based on effervescent tablet
(Cetylev) or a solution for oral administration that is prepared from the solution
for oral inhalation:
Infants, Children, and Adolescents: 72-hour regimen: Consists of 18 doses; total

dose delivered: 1,330 mg/kg.
Loading dose: Oral: 140 mg/kg; maximum dose: 15 g/dose.
Maintenance dose: Oral: 70 mg/kg every 4 hours for 17 doses; maximum

dose: 7.5 g/dose; repeat dose if emesis occurs within 1 hour of
administration; Note: Consultation with a poison control center or clinical
toxicologist is highly recommended when considering the discontinuation of
oral acetylcysteine prior to the conclusion of a full 18-dose course of
therapy.
IV: Acetadote:
Three-bag method: Infants, Children, and Adolescents: 21-hour regimen:

Consists of 3 doses; total dose delivered: 300 mg/kg.
Loading dose: IV: 150 mg/kg infused over 60 minutes; maximum dose: 15
g/dose.
Second dose: IV: 50 mg/kg infused over 4 hours; maximum dose: 5 g/dose.
Third dose: IV: 100 mg/kg infused over 16 hours; maximum dose: 10
g/dose.
Two-bag method: Limited data available: Note: The "two-bag method" has been
associated with fewer and milder nonallergic anaphylactic reactions as
compared to the manufacturer's labeled dosing (Wong 2016b).
Children ≥12 years and Adolescents: 20-hour regimen: Consists of 2 doses;

total dose delivered: 300 mg/kg; maximum total dose: 30 g (Wong 2016b):
First dose: IV: 200 mg/kg infused over 4 hours.
Second dose: IV: 100 mg/kg infused over 16 hours.
Respiratory conditions, adjuvant therapy: Note: Patients should receive an aerosolized

bronchodilator 10 to 15 minutes prior to acetylcysteine:
Nebulized inhalation:
Face mask, mouth piece, tracheostomy:
Infants: 1 to 2 mL of 20% solution (may be further diluted with sodium chloride

or sterile water for inhalation) or 2 to 4 mL of 10% solution (undiluted);
administer 3 to 4 times daily.
Children: 3 to 5 mL of 20% solution (may be further diluted with sodium chloride

or sterile water for inhalation) or 6 to 10 mL of 10% solution (undiluted);
administer 3 to 4 times daily.
Adolescents: 3 to 5 mL of 20% solution (may be further diluted with sodium

chloride or sterile water for inhalation) or 6 to 10 mL of 10% solution (undiluted);
administer 3 to 4 times daily; usual dosing range: 20% solution: 1 to 10 mL or
10% solution: 2 to 20 mL every 2 to 6 hours.
Tent, croupette: 10% or 20% solution: Dose must be individualized; dose is volume
of solution necessary to maintain a very heavy mist in tent or croupette; in some
cases, may require up to 300 mL solution/treatment.
Direct instillation: Children and Adolescents:
Endotracheal: 1 to 2 mL of 10% to 20% solution every 1 to 4 hours as needed.
Percutaneous endotracheal catheter: 1 to 2 mL of 20% or 2 to 4 mL of 10% solution

every 1 to 4 hours via syringe attached to catheter.
Diagnostic bronchogram: Children and Adolescents: Nebulization or endotracheal: 1 to 2

mL of 20% solution or 2 to 4 mL of 10% solution administered 2 to 3 times prior to procedure.
Distal intestinal obstruction syndrome (previously known as meconium ileus

equivalent): Limited data available; dosing regimens variable (polyethylene glycol has
become more widely used for this indication):
Oral:
Children <10 years: 30 mL of 10% solution diluted in 30 mL juice or soda 3 times/day

for 24 hours.
Children 10 years and Adolescents: 60 mL of 10% solution diluted in 60 mL juice or

soda 3 times/day for 24 hours.
Note: Prior to treatment, administer a phosphosoda enema. A clear liquid diet

should be used during the 24-hour acetylcysteine treatment.
Rectal enema: Children: Varying dosages; 100 to 300 mL of 4% to 6% solution 2 to 4

times daily; 50 mL of 20% solution 1 to 4 times daily and 5 to 30 mL of 10% to 20%
solution 3 to 4 times daily have been used; rectal enemas appear to have less favorable
results than oral administration (Mascarenhas 2003). Note: Higher concentrations (10%
to 20%) appear to increase fluid in the bowel and lead to increased incidence of adverse
effects (Perman 1975).
Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Obesity: Adult

Refer to indication-specific dosing for obesity-related information (may not be available for all
indications).
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific
product labeling. [DSC] = Discontinued product
Solution, Inhalation:
Generic: 10% [100 mg/mL] (4 mL, 10 mL, 30 mL); 20% [200 mg/mL] (10 mL, 30 mL)
Solution, Inhalation [preservative free]:
Generic: 10% [100 mg/mL] (4 mL, 10 mL, 30 mL); 20% [200 mg/mL] (4 mL, 10 mL, 30
mL)
Solution, Intravenous [preservative free]:
Acetadote: 200 mg/mL (30 mL)
Generic: 200 mg/mL (30 mL)
Tablet Effervescent, Oral:
Cetylev: 500 mg [DSC], 2.5 g [DSC] [contains edetate disodium; lemon-mint flavor]
Generic Equivalent Available: US

May be product dependent
Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific
product labeling.
Solution, Inhalation:
Parvolex: 20% [200 mg/mL] (10 mL, 30 mL)
Generic: 20% [200 mg/mL] (10 mL, 30 mL)
Administration: Adult
Inhalation: Acetylcysteine is incompatible with tetracyclines, erythromycin, amphotericin B,

iodized oil, chymotrypsin, trypsin, and hydrogen peroxide. Administer separately. Intermittent
aerosol treatments are commonly given when patient arises, before meals, and just before
retiring at bedtime.
Oral:
Effervescent tablets (Cetylev): Use within 2 hours of preparation. If the patient vomits
within 1 hour of administration, repeat that dose. If the patient is persistently unable to
retain the orally administered acetylcysteine, acetylcysteine may be administered by
nasoduodenal tube. An intravenous formulation of acetylcysteine may also be
considered.
Solution for oral administration: For the treatment of acetaminophen overdose, administer
orally as a 5% solution. Use within 1 hour of preparation. The unpleasant odor (sulfur-
like) becomes less noticeable as treatment progresses. If patient vomits within 1 hour of
dose, readminister. (Note: It is helpful to put the acetylcysteine on ice, in a cup with a
cover, and drink through a straw; alternatively, administer via an NG tube).
IV (Acetadote): Acetaminophen overdose:
Loading dose: Administer over 1 hour.
Second dose: Administer over 4 hours.
Third dose: Administer over 16 hours.
If the commercial IV form is unavailable, the solution for inhalation has been used; each
dose should be infused through a 0.2 micron Millipore filter (in-line) over 60 minutes (Yip
1998); intravenous administration of the solution for inhalation is not USP 797-compliant.
Alternative recommendations (off-label):
"Two bag method" (off-label dosing): Administer first dose (200 mg/kg) over 4
hours, then administer the second dose (100 mg/kg) over 16 hours (Wong 2016b).
"Single bag method" (off-label dosing): Administer initial dose (150 mg/kg) over 60
minutes, then decrease the rate and administer the remaining dose (14 mg/kg/hour)
over 20 hours (Johnson 2011). Note: Patients weighing >69 kg will require a second
bag to complete the dosing regimen.
Administration: Pediatric
Oral: Differs based on use.
Acetaminophen poisoning:
Effervescent tablets: Cetylev: Use within 2 hours of preparation. If the patient vomits
within 1 hour of administration, repeat that dose. If the patient is persistently unable
to retain the orally administered acetylcysteine, acetylcysteine may be administered
by nasoduodenal tube.
Solution for oral administration: Administer as a 5% solution (see Preparation for

Administration); use within 1 hour of preparation. If patient vomits within 1 hour of
dose, readminister. Note: The unpleasant odor (sulfur-like) becomes less noticeable
as treatment progresses. It is helpful to put the acetylcysteine on ice, in a cup with a
cover, and drink through a straw; alternatively, administer via an NG tube.
Parenteral: Acetaminophen poisoning:
IV: Acetadote:
Three-bag method: Neonates, Infants, Children, and Adolescents:
Loading dose: Administer IV over 60 minutes.
Second dose: Administer IV over 4 hours.
Third dose: Administer IV over 16 hours.
Note: If the commercial IV form is unavailable, the solution for inhalation has
been used; each dose should be infused through a 0.2 micron Millipore filter (in-
line) over 60 minutes (Yip 1998); intravenous administration of the solution for
inhalation is not USP 797-compliant.
Two-bag method: Children ≥12 years and Adolescents:
First dose: Administer IV over 4 hours.
Second dose: Administer IV over 16 hours.
Inhalation solution: May be administered by nebulization either undiluted (both 10% and 20%)
or diluted in NS. Acetylcysteine solution for inhalation is incompatible with tetracyclines,
erythromycin, amphotericin B, iodized oil, chymotrypsin, trypsin, and hydrogen peroxide.
Administer separately. Intermittent aerosol treatments are commonly given when patient
arises, before meals, and just before retiring at bedtime.
Rectal: Inhalation solution may be given undiluted (10% to 20%) or diluted to 4% to 6%

solution and administer rectally (Mascarenhas 2003; Perman 1975).
Use: Labeled Indications
Acetaminophen overdose: To prevent or lessen hepatic injury after ingestion of a potentially

hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated
supratherapeutic ingestion (RSTI).
Mucolytic: Adjunct therapy in patients with abnormal, viscid, or inspissated mucous

secretions in conditions such as: chronic bronchopulmonary disease (chronic emphysema,
emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis,
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; posttraumatic chest conditions;
atelectasis due to mucous obstruction; diagnostic bronchial studies (bronchograms,
bronchospirometry, bronchial wedge catheterization).
Medication Safety Issues

Sound-alike/look-alike issues:
https://bibvirtual.upch.edu.pe:2050/contents/acetylcysteine-drug-information/print?search=acetylcysteine&source=panel_search_result&selecte… 10/22
Acetylcysteine may be confused with acetylcholine
Mucomyst may be confused with Mucinex
Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless
otherwise specified.
Intravenous:
>10%:
Immunologic: Autoimmune disease (14% to 18%)
Miscellaneous: Anaphylactoid reaction (1% to 18%)
1% to 10%:
Cardiovascular: Flushing (1% to 3%), tachycardia (1% to 4%), edema (1% to 2%)
Dermatologic: Urticaria (≤21%), rash (2% to ≤21%), pruritus (1% to ≤21%)
Gastrointestinal: Vomiting (2% to 10%), nausea (1% to 6%)
Respiratory: Pharyngitis (≤1%), rhinorrhea (≤1%), rhonchi (≤1%), throat tightness

(≤1%)
<1%, postmarketing, and/or case reports (limited to important or life-threatening):

Anaphylaxis, angioedema, bronchospasm, chest tightness, cough, dizziness (Sandilands
2008), dyspnea (Sandilands 2008), hypotension, respiratory distress, stridor, wheezing
Oral: Frequency not defined.
Cardiovascular: Chest tightness, hypotension (Bebarta 2010; Sandilands 2009)
Dermatologic: Rash (with or without fever), urticaria
Gastrointestinal: Gastrointestinal symptoms, nausea, vomiting
Hypersensitivity: Hypersensitivity reaction
Respiratory: Bronchospasm, bronchitis
<1%, postmarketing, and/or case reports (limited to important or life-threatening):

Angioedema (Bebarta 2010), pruritus (Bebarta 2010), tachycardia (Bebarta 2010)
Contraindications
Hypersensitivity to acetylcysteine or any component of the formulation.
Effervescent tablet (Cetylev): There are no contraindications listed in the manufacturer's

labeling.
Warnings/Precautions
Concerns related to adverse effects:
• Anaphylactoid reactions: Acute flushing and erythema have been reported; usually
occurs within 30 to 60 minutes and may resolve spontaneously. Serious anaphylactoid
reactions (some fatal) have also been reported and are more commonly associated with
IV administration, but also occur with oral administration (Mroz 1997). When used for
acetaminophen overdose, the incidence is reduced when the initial intravenous loading
dose is administered over 60 minutes. The acetylcysteine infusion may be interrupted
until the treatment of allergic symptoms is initiated; the infusion can then be carefully
restarted. Treatment for anaphylactoid reactions should be immediately available.
Conversely, patients with high acetaminophen concentrations (>150 mg/L) may be at a
reduced risk for anaphylactoid reactions (Pakravan 2008; Sandilands 2009; Waring
2008).
• Fluid overload: IV administration can cause fluid overload, potentially resulting in

hyponatremia, seizure and death. To avoid fluid overload in patients ≤40 kg and those
requiring fluid restriction, decrease volume of diluent proportionally.
Disease-related concerns:
• Asthma/bronchospasm: Use caution in patients with asthma or history of

bronchospasm; these patients may be at increased risk of hypersensitivity reactions.
Other warnings/precautions:
• Acute acetaminophen overdose: Appropriate use: Acetylcysteine is indicated in patients

with a serum acetaminophen concentration that indicates they are at "possible" risk or
greater for hepatotoxicity when plotted on the Rumack-Matthew nomogram. There are
several situations where the nomogram is of limited use. Serum acetaminophen
concentrations obtained <4 hours postingestion are not reliable, except to document the
presence of acetaminophen (Seifert 2015). Patients presenting late may have
undetectable serum concentrations, despite having received a toxic dose. The
nomogram is less predictive of hepatic injury following an acute overdose with an
extended release acetaminophen product. The nomogram also does not take into
account patients who may be at higher risk of acetaminophen toxicity (eg, alcoholics,
malnourished patients, concurrent use of CYP2E1 enzyme-inducing agents [eg,
isoniazid]). Nevertheless, acetylcysteine should be administered to any patient with signs
of hepatotoxicity, even if the serum acetaminophen concentration is low or undetectable.

Patients who present >24 hours after an acute ingestion or patients who present
following an acute ingestion at an unknown time may be candidates for acetylcysteine
therapy; consultation with a poison control center or clinical toxicologist is highly
recommended.
• Repeated supratherapeutic ingestion (RSTI) of acetaminophen: Appropriate use: The

Rumack-Matthew nomogram is not designed to be used following RSTIs. In general, an
accurate past medical history, including a comprehensive acetaminophen ingestion
history, in conjunction with AST concentrations and serum acetaminophen
concentrations, may give the clinician insight as to the patient's risk of acetaminophen
toxicity. Some experts recommend that acetylcysteine be administered to any patient with
"higher than expected" serum acetaminophen concentrations or serum acetaminophen
concentration >10 mcg/mL, even in the absence of hepatic injury; others recommend
treatment for patients with laboratory evidence and/or signs and symptoms of
hepatotoxicity (Hendrickson 2006; Jones 2000). Consultation with a poison control center
or a clinical toxicologist is highly recommended.
Dosage form specific issues:
• Effervescent tablets (Cetylev): Contains sodium; consider acetylcysteine treatment as a

source of sodium in patients who may be sensitive to excess sodium intake (eg, heart
failure, hypertension, renal impairment).
• Oral administration: Gastrointestinal hemorrhage: Oral administration of acetylcysteine

may result in nausea and vomiting, which may exacerbate vomiting associated with
acetaminophen overdose. Therefore, patients at risk of gastrointestinal hemorrhage (eg,
esophageal varices, peptic ulcer) may experience an even higher risk of gastrointestinal
hemorrhage during therapy.
• Inhalation: Since increased bronchial secretions may develop after inhalation,

percussion, postural drainage, and suctioning should follow. If bronchospasm occurs,
administer a bronchodilator; discontinue acetylcysteine if bronchospasm progresses.
Metabolism/Transport Effects
None known.
Drug Interactions
(For additional information: Launch drug interactions program)
There are no known significant interactions.
Pregnancy Considerations
Acetylcysteine crosses the placenta.
Acetylcysteine may be used to treat acetaminophen overdose during pregnancy (Wilkes 2005).
Delaying treatment to pregnant women with acetaminophen toxicity may increase the risk of
adverse maternal and fetal outcomes. In general, medications used as antidotes should take into
consideration the health and prognosis of the mother; antidotes should be administered to
pregnant women if there is a clear indication for use and should not be withheld because of fears
of teratogenicity (Bailey 2003).
Breast-Feeding Considerations
It is not known if acetylcysteine is excreted in breast milk. According to the manufacturer, the
decision to continue or discontinue breast-feeding during therapy should take into account the
risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to
the mother. Based on pharmacokinetics, acetylcysteine should be nearly completely cleared
30 hours after administration; breast-feeding women may consider pumping and discarding
breast milk for 30 hours after administration.
Monitoring Parameters
Acetaminophen overdose: Monitor patient for the development of anaphylaxis or

anaphylactoid reactions; monitor serum acetaminophen concentrations, AST, ALT, bilirubin,
PT, INR, serum creatinine, BUN, serum glucose, hemoglobin, hematocrit, and electrolytes.
Assess patient for nausea, vomiting, and skin rash following oral administration. Reassess
LFTs for possible hepatotoxicity every 4 to 6 hours. An early elevation in the INR may be
related to acetylcysteine therapy (Schmidt 2002).
Acute ingestion: Obtain the first acetaminophen concentration 4 hours postingestion (or as
soon as possible thereafter); plot on the Rumack-Matthew nomogram. In patients who have
ingested an extended release formulation of acetaminophen or have coingested an agent
known to delay gastric emptying, obtain a repeat serum acetaminophen measurement 4 to 6
hours following the first measurement if the original concentration (taken at 4 to 8 hours
postingestion) when plotted on the Rumack-Matthew nomogram indicated that treatment was
not necessary.
Mechanism of Action
Acetaminophen overdose: Acetylcysteine acts as a hepatoprotective agent by restoring

hepatic glutathione, serving as a glutathione substitute, and enhancing the nontoxic sulfate
conjugation of acetaminophen.
Mucolytic: Exerts mucolytic action through its free sulfhydryl group which opens up the
disulfide bonds in the mucoproteins thus lowering mucous viscosity.
Pharmacodynamics and Pharmacokinetics
Onset of action: Inhalation: 5 to 10 minutes
Duration: Inhalation: >1 hour
Distribution: Vdss: 0.47 L/kg
Protein binding: 66% to 87%
Metabolism: Undergoes extensive first pass metabolism to form cysteine and disulfides (N,N-
diacetylcysteine and N-acetylcysteine); cysteine is further metabolized to form glutathione and
other metabolites
Half-life elimination:
Reduced acetylcysteine: 2 hours
Total acetylcysteine: Adults: 5.6 hours; Newborns: 11 hours
Effervescent tablets: Terminal half-life: 18.1 hours
Time to peak, plasma: Oral solution: 1 to 2 hours; Effervescent tablets: 1 to 3.5 hours
(median: 2 hours)
Excretion: Urine (13% to 38%)
Pricing: US
Solution (Acetadote Intravenous)
200 mg/mL (per mL): $8.62
Solution (Acetylcysteine Inhalation)
10% (per mL): $2.49 - $3.07
20% (per mL): $1.80 - $3.84
Solution (Acetylcysteine Intravenous)
200 mg/mL (per mL): $4.00 - $7.52
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as
reference price only. A range is provided when more than one manufacturer's AWP price is
available and uses the low and high price reported by the manufacturers to determine the range.
The pricing data should be used for benchmarking purposes only, and as such should not be used
alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to
be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all
warranties of any kind or nature, whether express or implied, and assumes no liability with respect
to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be
liable for special, indirect, incidental, or consequential damages arising from use of price or price
range data. Pricing data is updated monthly.
Brand Names: International

Ac-Lyte (PH);
ACC (AR, BG, CH, CZ, DE, EG, HU, LB, LU, MX, RO, RU, SA, SK, UA, ZA);
ACC
200 (AE, BH, EE, KW, QA);
ACC Long (BH, QA);
Acemuc (EC);
Acemuk (AR, CL);
Acesolv (EG);
Acestad (UA);
Acet (TW);
Acetadote (AU, NZ);
Acetein (KR);
Acetimax (PH);
Acetin (ID, MY);
Acetylcystein NM Pharma (SE);
Acetylcystein Tika (SE);
Acetyst (DE);
Actein (HK);
Aflux (CO,
EC);
Aires (BR);
Bisolbruis (NL);
Brimodin (PE);
Bromuc (BR);
Bronchocil (BE);
Broncoflem (PH);
Broncolium (AR);
Brunac (JO);
Cetilan (PH);
Cilol (LK);
Cirocyst (LK);
Codotussyl (SG);
Cystaline
(TH);
Debeneweist (EG);
Dextein (PH);
Drenaflen (DO, EC);
Ecomucyl (CH);
Encore (TW);
Enumine NAC (TH);
Exflem (PH);
Exomuc (FR, LB, LU, VN);
Fabrol (AT, GR);
Flemex AC (TH);
Flemex-AC OD (TH);
Flucee (PH);
Flucil (TH);
Fluidasa (CL, VN);
Fluidine (EC);
Fluimicil (CH,
DE);
Fluimiquil (LU);
Fluimucil (AR, AT, BG, BR, CO, CZ, ES, FR, GR, HK, HU, ID, IT, LB, NL, PE,
PL, PT, QA, RU, SA, SG, TH, TW, UA, VN);
Fluimucil A (MY, PK);
Fluimukan (HR, SI);
Flumex
(PH);
Flumil (ES);
Flumixol (CO);
Flutafin (TW);
Genac (FR);
Glotamuc (VN);
Granon (DK);
Hidonac (EG, HK, ID, MY, PH, TW);
Icystein (TW);
Ilube (GB);
L-Acys (ID);
L-Cimexyl (SG);
Lubrisec (AR);
Lysomucil (BE, CR, DO, GT, HN, LU, NI, PA, SV);
Lysox (BE, LU);
Madame Pearl's
Mucolytic (HK);
Mentopin (MY, SG);
Mitux (VN);
Moktin (KR);
Muclear (TH);
Mucobene (AT);
Mucocar (PE);
Mucocystein (PH);
Mucofillin (JP);
Mucofluid (EE);
Mucolair (LU);
Mucolator (LU,
MY);
Mucolid SF (TH);
Mucolitico (CL, CN);
Mucolysin (IS);
Mucolyte (LK);
Mucomist (BD);
Mucomyst (DK, FI, FR, GR, KR, LU, NO, SE);
Mucomystendo (FR);
Mucoserin (KR);
Mucosoft
(BG);
Mucosten (KR);
Mucosys (IN);
Mucotic (TH);
Mucylin (ID);
Mufresin (PH);
Muterin (KR);
Muxatil (PY);
Mysoven (TH);
N-Acc (ID);
NAC (TR);
NAC-ratiopharm (LU);
Nacetyl (PH);
Parvolex
(GB, IE, NZ, ZA);
Pectocil (ID);
Pectomucil (LU);
Reolin (IL);
Respar (ID);
Respicyl (ID);
Rinofluimucil (JO);
Rumicil (LU);
Sebron (KR);
Sensemoc (CR, DO, GT, HN, NI, PA, SV);
Simucil
(ID);
Simucin (TH);
Siran 200 (IL);
Siran Forte (ID);
Solmucol (CZ, HU, IT, LU, SG, SK);
Solvimyst
(EG);
Spatam (SG);
Sputopur (HU);
Stecin (KR);
Stenac (MY, SG);
Systalin (BD);
Tancore (TW);
Tirocular (PT);
Toflux (AR);
Touxium Mucolyticum (LU);
Viscotin (BD);
Viskoferm (SE)
For country abbreviations used in Lexicomp ( show table)
Use of UpToDate is subject to the Subscription and License Agreement.
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Acetylcysteine: Drug information

Copyright 1978-2021 Lexicomp, Inc. All rights reserved.

Brand Names: Canada

preexisting liver disease. In patients with persistently elevated acetaminophen concentrations,

Note: There is no reason to withhold activated charcoal in a patient with an

72-hour regimen: Consists of 18 doses; total dose delivered: 1,330 mg/kg.

Loading dose: 140 mg/kg.

21-hour regimen: Consists of 3 doses; total dose delivered: 300 mg/kg.

Loading dose: 150 mg/kg (maximum: 15 g) infused over 1 hour.

Second dose: 50 mg/kg (maximum: 5 g) infused over 4 hours.

Third dose: 100 mg/kg (maximum: 10 g) infused over 16 hours.

First dose: 200 mg/kg infused over 4 hours.

Second dose: 100 mg/kg infused over 16 hours.

72-hour regimen: Consists of 18 doses; total dose delivered: 142.5 g.

Maintenance dose: 7.5 g every 4 hours.

IV (Acetadote): 21-hour regimen: Consists of 3 doses; total dose delivered: 30 g.

Loading dose: 15 g infused over 1 hour.

Second dose: 5 g infused over 4 hours.

Third dose: 10 g infused over 16 hours.

Adjuvant therapy in respiratory conditions:

Note: Patients should receive an aerosolized bronchodilator 10 to 15 minutes prior to

Inhalation, nebulization (face mask, mouth piece, tracheostomy): Acetylcysteine

of 10% solution until nebulized given 3 to 4 times/day; dosing range: 1 to 10 mL of 20%

Inhalation, nebulization (tent, croupette): Dose must be individualized; may require up

Into tracheostomy: 1 to 2 mL of 10% to 20% solution every 1 to 4 hours.

Through percutaneous intratracheal catheter: 1 to 2 mL of 20% or 2 to 4 mL of 10%

Diagnostic bronchogram: Nebulization or intratracheal: 1 to 2 mL of 20% solution or 2 to 4

Dosing: Renal Impairment: Adult

Dosing: Hepatic Impairment: Adult

(For additional information see "Acetylcysteine: Pediatric drug information")

doses should be administered is unclear. Possible candidates for extended therapy

Oral: Effervescent tablet (Cetylev) or solution for oral administration (using

Infants, Children, and Adolescents: 72-hour regimen: Consists of 18 doses; total

Loading dose: Oral: 140 mg/kg; maximum dose: 15 g/dose.

Maintenance dose: Oral: 70 mg/kg every 4 hours for 17 doses; maximum

Three-bag method: Infants, Children, and Adolescents: 21-hour regimen:

Children ≥12 years and Adolescents: 20-hour regimen: Consists of 2 doses;

First dose: IV: 200 mg/kg infused over 4 hours.

Second dose: IV: 100 mg/kg infused over 16 hours.

Respiratory conditions, adjuvant therapy: Note: Patients should receive an aerosolized

Face mask, mouth piece, tracheostomy:

Infants: 1 to 2 mL of 20% solution (may be further diluted with sodium chloride

Children: 3 to 5 mL of 20% solution (may be further diluted with sodium chloride

Adolescents: 3 to 5 mL of 20% solution (may be further diluted with sodium

Direct instillation: Children and Adolescents:

Endotracheal: 1 to 2 mL of 10% to 20% solution every 1 to 4 hours as needed.

Percutaneous endotracheal catheter: 1 to 2 mL of 20% or 2 to 4 mL of 10% solution

Diagnostic bronchogram: Children and Adolescents: Nebulization or endotracheal: 1 to 2

Distal intestinal obstruction syndrome (previously known as meconium ileus

Children <10 years: 30 mL of 10% solution diluted in 30 mL juice or soda 3 times/day

Children 10 years and Adolescents: 60 mL of 10% solution diluted in 60 mL juice or

Note: Prior to treatment, administer a phosphosoda enema. A clear liquid diet

Rectal enema: Children: Varying dosages; 100 to 300 mL of 4% to 6% solution 2 to 4

Dosing: Renal Impairment: Pediatric

Dosing: Hepatic Impairment: Pediatric

Dosing: Obesity: Adult

Solution, Inhalation [preservative free]:

Solution, Intravenous [preservative free]:

Acetadote: 200 mg/mL (30 mL)

Generic: 200 mg/mL (30 mL)

Tablet Effervescent, Oral: