Acetylcysteine: Drug information
Copyright 1978-2018 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
Brand Names: Canada
  • Acetylcysteine Injection;
  • Acetylcysteine Solution;
  • Mucomyst;
  • 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 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: 10 g] infused over 16 hours) is administered; however, this dose may be inadequate in some patients (Rumack 2012). Consultation with a poison control center or clinical toxicologist is highly recommended to determine optimal patient care.

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 (Acetadote):

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 according to the following table:

Acetadote Dosing / Fluid Volume Guidelines for Patients ≤40 kg

Body Weight

(kg)

Loading Dose

150 mg/kg over 1 hour

Second Dose

50 mg/kg over 4 hours

Third Dose

100 mg/kg over 16 hours

Acetadote

(mL)

Diluent

(mL)

Acetadote

(mL)

Diluent

(mL)

Acetadote

(mL)

Diluent

(mL)

40

30

100

10

250

20

500

30

22.5

100

7.5

250

15

500

21

15.75

100

5.25

250

10.5

500

20

15

60

5

140

10

280

15

11.25

45

3.75

105

7.5

210

10

7.5

30

2.5

70

5

140

5

3.75

15

1.25

35

2.5

70

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: Pediatric

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

Acetaminophen overdose: Infants, Children, and Adolescents: Refer to adult dosing.

Adjuvant therapy in respiratory conditions:

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

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.

Infants: 1 to 2 mL of 20% solution or 2 to 4 mL 10% solution until nebulized given 3 to 4 times/day

Children: Refer to adult dosing.

Inhalation, nebulization (tent, croupette): Children: Refer to adult dosing.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Dosing: Obesity

Refer to indication-specific dosing for obesity-related information (may not be available for all indications).

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free]: 20% (30 mL)

Acetadote: 20% [200 mg/mL] (30 mL)

Solution, for inhalation/oral: 10% [100 mg/mL] (10 mL, 30 mL); 20% [200 mg/mL] (10 mL, 30 mL)

Solution, for inhalation/oral [preservative free]: 10% [100 mg/mL] (4 mL, 10 mL, 30 mL); 20% [200 mg/mL] (4 mL, 10 mL, 30 mL)

Tablet Effervescent, Oral:

Cetylev: 500 mg, 2.5 g [contains edetate disodium; lemon mint flavor]

Generic Equivalent Available (US)

Yes; excludes effervescent tablet.

Administration

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.

Use

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).

Use: Off-Label

Distal intestinal obstruction syndrome (DIOS, previously referred to as meconium ileus equivalent)

Medication Safety Issues
Sound-alike/look-alike issues:

Acetylcysteine may be confused with acetylcholine

Mucomyst may be confused with Mucinex

Adverse Reactions

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 2008)

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 (see table in dosing section).

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 Implications

Adverse events have not been observed in animal reproduction studies. Based on limited reports using acetylcysteine to treat acetaminophen overdose in pregnant women, acetylcysteine has been shown to cross the placenta and may provide protective concentrations in the fetus.

Acetylcysteine may be used to treat acetaminophen overdose in during pregnancy (Wilkes 2005). 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/Kinetics

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 (30 mL): $258.74

Solution (Acetylcysteine Inhalation)

10% (10 mL): $12.60

20% (10 mL): $14.58

Solution (Acetylcysteine Intravenous)

200 mg/mL (30 mL): $225.60

Tablet, effervescent (Cetylev Oral)

2.5 g (20): $433.96

500 mg (20): $86.80

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, CR, CZ, DE, DO, GT, HN, HU, LB, LU, MX, NI, PA, RU, SA, SK, SV, ZA);
  • ACC 200 (AE, BH, EE, KW, QA);
  • ACC Long (QA);
  • Acemuc (EC);
  • Acemuk (AR, CL);
  • 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);
  • 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);
  • 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, VN);
  • Fluimucil A (MY, PK);
  • Fluimukan (HR, SI);
  • Flumex (PH);
  • Flumil (ES);
  • Flumixol (CO);
  • Flutafin (TW);
  • Genac (FR);
  • Glotamuc (VN);
  • Granon (DK);
  • Hidonac (HK, ID, MY, PH, TH, TW);
  • Icystein (TW);
  • Ilube (GB);
  • 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);
  • 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);
  • 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);
  • Pulmovital (CR, DO, GT, HN, NI, PA, SV);
  • Reolin (IL);
  • Respar (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);
  • Spatam (SG);
  • Sputopur (HU);
  • Stacytine (VN);
  • Stecin (KR);
  • Stenac (MY);
  • Systalin (BD);
  • Tancore (TW);
  • Tirocular (PT);
  • Toflux (AR);
  • Touxium Mucolyticum (LU);
  • Viscotin (BD);
  • Viskoferm (SE)
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